The first thing that stands out is that even under old protocols the time between trial phases for Anavex 2-73 does not seem to be unusual.
Most of these drugs are either plaque attack or re-purposed. I don't see much that is novel or apt to be competitive to 2-73 if it works as we hope it will.
Copy in red is from Google
1
Recruiting A Study of CNP520 Versus Placebo in Participants at Risk for the Onset of Clinical Symptoms of Alzheimer's Disease Alzheimer's Disease Drug: CNP520 50mg Drug: CNP520 15mg Other: Placebo to CNP520 Banner Alzheimer's Institute, 901 East Willetta Street Phoenix, Arizona, United States Banner Sun Health Research Institute, 10515 West Santa Fe Drive, Building B Sun City, Arizona, United States ATP Clinical Research Inc, 3151 Airway Avenue T 3 Costa Mesa, California, United States (and 53 more...)
Novartis and Amgen announce expanded collaboration with Banner ... https://www.novartis.com/.../novartis-and-amgen-announce-expanded-collaboration-b... Nov 2, 2017 - Parties to collaborate on a new Generation Study 2, assessing whether investigational drug CNP520 can prevent or delay the symptoms of Alzheimer's disease (AD); Clinical trial is part of the Generation Program, which includes cognitively healthy people at genetic risk of developing AD; Generation Study ...
A Study of CNP520 Versus Placebo in Participants at Risk for the ... https://clinicaltrials.gov/ct2/show/NCT03131453 Apr 27, 2017 - The purpose of this study is to determine the effects of CNP520 on cognition, global clinical status, and underlying AD pathology, as well as the safety of CNP520, in people at risk for the onset of clinical symptoms of AD based on their age, APOE genotype and elevated amyloid. Actual Study Start Date?: ?August 3, 2017 Study Type?: ?Interventional (Clinical Trial) Estimated Study Completion Date?: ?July 30, 2024 Estimated Primary Completion Date?: ?July 30, 2024
2
Not yet recruiting BAC in Patient With Alzheimer's Disease or Vascular Dementia Alzheimer's Disease Vascular Dementia Drug: BAC Other: BAC Matched Vehicle National Cheng Kung University Hospital Tainan, Taiwan
2017 Medicines in Development for Alzheimer's Disease - PhRMA phrma-docs.phrma.org/files/.../MID-Update_Alzheimers-Disease_2017-Drug-List.pdf mild cognitive impairment in. Phase II. (amyloid beta-protein inhibitor). New York, NY patients at risk for Alzheimer's www.cerespir.com disease. CSTC1 (BAC). Charsire Biotechnology. Alzheimer's disease. Phase II. Tainan, Taiwan www.charsire.com.tw. CT1812. Cognition Therapeutics mild to moderate Alzheimer's disease.
3
Recruiting Brain Imaging and Safety Study Evaluating TRx0237 in Subjects With Mild Alzheimer's Disease Alzheimer Disease Drug: TRx0237 8 mg/day Drug: Placebo Arizona Research Center Phoenix, Arizona, United States Arizona Health Science Center Tucson, Arizona, United States ATP Clinical Research Costa Mesa, California, United States (and 52 more...)
LMTM | ALZFORUM https://www.alzforum.org/therapeutics/lmtm TRx 0237 (LMTX™) is a second-generation tau protein aggregation inhibitor for the treatment of Alzheimer's disease (AD) and frontotemporal dementia. It is a replacement formulation for Rember, the first company's first proprietary formulation of methylthioninium chloride (MTC). Both TRx 0237 and Rember are purified ...
4
Not yet recruiting Phase 2 Study of BIIB092 in Participants With Early Alzheimer's Disease Alzheimer's Disease Drug: BIIB092 Drug: Placea
BIIB092 | ALZFORUM https://www.alzforum.org/therapeutics/biib092 Dec 14, 2017 - Overview. Name: BIIB092 Synonyms: BMS-986168, IPN007 Therapy Type: Immunotherapy (passive) (timeline) Target Type: Tau (timeline) Condition(s): Progressive Supranuclear Palsy, Alzheimer's Disease U.S. FDA Status: Progressive Supranuclear Palsy (Phase 2), Alzheimer's Disease (Phase 2) Phase 2 Study of BIIB092 in Participants With Early Alzheimer's ... https://clinicaltrials.gov/ct2/show/NCT03352557
Nov 24, 2017 - To evaluate the safety and tolerability of BIIB092 in participants with mild cognitive impairment (MCI) due to Alzheimer's disease (AD) or with mild AD. To evaluate the efficacy of multiple doses of BIIB092 in slowing cognitive and functional impairment in participants with MCI due to AD or with mild AD. Study Type?: ?Interventional (Clinical Trial) Estimated Study Completion Date?: ?September 8, ... Anticipated Study Start Date?: ?February 23, 2018 Estimated Enrollment?: ?528 participants
5
Recruiting Clinical Trial to Explore the the Amyloid Beta Draining Effect of Thiethylperazine (TEP) in Subjects With Newly Diagnosed Early-to-mild Dementia Due to Alzheimer's Disease (AD) in Comparison to Healthy Volunteers Alzheimer Disease Drug: TEP Klinik für Psychiatrie und Psychotherapie Universitätsmedizin Göttingen Göttingen, Germany Zentralinstitut für seelische Gesundheit, Medizinische Fakultät Mannheim, Universität Heidelberg, Mannheim, Germany
Thiethylperazine - DrugBank https://www.drugbank.ca/drugs/DB00372 Jun 13, 2005 - Not Available; Pharmacodynamics. Thiethylperazine, an atypical antipsychotic agent, is used to treat both negative and positive symptoms of schizophrenia, acute mania with bipolar disorder, agitation, and psychotic symptoms in dementia. Future uses may include the treatment of obsessive-compulsive ... ?Identification · ?Pharmacology · ?Interactions · ?References
6
Recruiting A Study to Evaluate the Efficacy and Safety of RO7105705 in Patients With Prodromal to Mild Alzheimer's Disease Alzheimer's Disease Drug: RO7105705 Drug: Placebo Drug: [18F]GTP1 University of Alabama at Birmingham Birmingham, Alabama, United States California Clinical Trials Glendale, California, United States Institute for Memory Impairments Irvine, California, United States (and 89 more...)
a phase i study to evaluate the safety and tolerability of ro7105705 in ... www.alzheimersanddementia.com/article/S1552-5260(17)33159-X/fulltext by GA Kerchner - ?2017 RO7105705 is a humanized anti-tau monoclonal antibody in development for the treatment of Alzheimer's disease (AD) and other neurodegenerative diseases. RO7105705 binds specifically to tau and is intended to intercept tau in the extracellular space of the brain, blocking cell-to-cell spread of tau pathology. No adverse ...
7
Recruiting A Study of LY3002813 and LY3202626 in Participants With Early Symptomatic Alzheimer's Disease Alzheimer Disease Drug: LY3002813 Drug: LY3202626 Drug: Placebo (IV) Drug: Placebo (Oral) Banner Alzheimer's Institute Phoenix, Arizona, United States St Josephs Hospital and Medical Center Phoenix, Arizona, United States Banner Sun Health Research Institute Sun City, Arizona, United States (and 67 more...)
LY3002813 | ALZFORUM https://www.alzforum.org/therapeutics/ly3002813 LY3002813 is a monoclonal antibody developed from mouse mE8-IgG2a. This antibody recognizes Aß(p3-42), a pyroglutamate form of Aß that is aggregated in amyloid plaques. Most Aß antibodies in therapeutic development bind various soluble or insoluble species but have low affinity to deposited amyloid plaques.
8
Not yet recruiting Efficacy and Safety Study of Gantenerumab in Participants With Early Alzheimer's Disease (AD) Alzheimer Disease Drug: Gantenerumab Drug: Placebo Center for Neurosciences Tucson, Arizona, United States CITrials, Inc. Bellflower, California, United States Global Clinical Trials; Irvine, CA Irvine, California, United States (and 165 more...)
Gantenerumab | ALZFORUM https://www.alzforum.org/therapeutics/gantenerumab Gantenerumab is a fully human IgG1 antibody designed to bind with subnanomolar affinity to a conformational epitope on Aß fibrils. It encompasses both N-terminal and central amino acids of Aß. The therapeutic rationale for this antibody is that it acts centrally to disassemble and degrade amyloid plaques by recruiting ...
Roche is bringing back gantenerumab from the dead, taking another ... https://endpts.com/roche-is-bringing-back-gantenerumab-from-the-dead-taking-anoth... Mar 7, 2017 - Nothing has worked in Alzheimer's R&D over the last 14 years, and gantenerumab looked like it would join a list of the most prominent drugs in the field to wash out of a big Phase III. But researchers have also been emboldened by better diagnostics to select patients as well as by the early data from ...
9
Not yet recruiting Safety and Efficacy Study of Gantenerumab in Participants With Early Alzheimer's Disease (AD) Alzheimer's Disease Drug: Gantenerumab Drug: Placebo Noesis Pharma Clinical Trials Phoenix, Arizona, United States Mayo Clinic Scottsdale, Arizona, United States Fullerton Neurology and Headache Center Fullerton, California, United States (and 157 more...)
see above
10
Recruiting Proof-of-Concept Study of a Selective p38 MAPK Alpha Inhibitor, Neflamapimod, in Subjects With Mild Alzheimer's Disease Alzheimer Disease Drug: neflamapimod Other: placebo Anchor Neuroscience Pensacola, Florida, United States
EIP Pharma Publishes Positive Alzheimer's Disease Clinical Study Data with Neflamapimod Phase 2a Results Published in Annals of Clinical and Translational Neurology Demonstrate Statistically Significant Improvement in Episodic Memory Function in Patients with Alzheimer's Disease
Company Initiates Phase 2b (REVERSE-SD) Confirmatory Study with Neflamapimod
NEWS PROVIDED BY
EIP Pharma LLC Mar 07, 2018, 08:00 ET
SHARE THIS ARTICLE
CAMBRIDGE, Mass., March 7, 2018 /PRNewswire/ -- EIP Pharma LLC (www.eippharma.com), a CNS-focused therapeutics company, today announced that the results from a 3-month Phase 2a clinical study with neflamapimod, a brain-penetrant oral small molecule that inhibits the intra-cellular enzyme p38 MAP kinase alpha (p38a), in patients with early Alzheimer's disease have been published in the Annals of Clinical and Translational Neurology. Based on the findings from phase 2a, the company has initiated a 6-month phase 2b clinical study (REVERSE-SD) designed to evaluate neflamapimod's activity in reversing synaptic dysfunction ("SD"), as assessed by tests of episodic memory in patients with mild Alzheimer's disease.
"Significant unmet need exists for improved Alzheimer's treatments which is why we are so encouraged by these data demonstrating neflamapimod's potential to improve memory function in patients with Alzheimer's disease," said John Alam, CEO of EIP Pharma. "We look forward to reporting top-line results of the recently initiated REVERSE-SD Phase 2b clinical study in the second half of 2019."
"Neflamapimod demonstrated a robust signal of efficacy on measures of episodic memory in this study," said Professor Philip Scheltens of the VU Medical Center in Amsterdam (Netherlands), first author of the publication and global principal investigator for REVERSE-SD, "Through conducting the REVERSE-SD study we hope to definitively confirm the effects on episodic memory seen in our phase 2a study in a placebo-controlled study."
The paper, titled 'An exploratory clinical study of p38a kinase inhibition in Alzheimer's disease' (https://doi.org/10.1002/acn3.549), reports the results of the Phase 2a study with neflamapimod (NCT02423122), in which 16 patients with early Alzheimer's disease were enrolled. The major clinical finding was statistically significant improvement in episodic memory function with neflamapimod, as assessed by immediate recall (p=0.001) and delayed recall (p<0.001) composites of the relevant components of the Wechsler Memory Scale (WMS). The improvement was progressive over the 3-months of treatment and at the end of treatment the within-subject treatment Effect Size was in medium to large range: 0.59 for immediate recall and 0.67 for delayed recall. In addition, individual subject plasma drug concentration profiles were highly significantly positively correlated with the change in combined WMS immediate and delayed recall (p < 0.0001, r2 = 0.70). The primary biomarker endpoint in the study was change in brain amyloid plaque load by quantitative dynamic amyloid PET scanning, with 4 of the 16 patients meeting pre-defined responder criteria for a significant reduction in brain amyloid plaque load between baseline and month 3 PET scans. No correlation was evident between improvement in episodic memory function and reduction in brain amyloid plaque load.
About REVERSE-SD 150 patients with mild Alzheimer's disease will be randomized on a double-blind basis to placebo or 40 mg of neflamapimod twice daily for 24 weeks. Inclusion criteria include Clinical Dementia Rating scale (CDR) 0.5 or 1.0 with documented memory deficit, MMSE 20 to 28, and positive AD-related cerebrospinal fluid biomarkers. The primary endpoint will be episodic memory, with secondary endpoints including CDR-SB, MMSE, and CSF biomarkers. Further details are available at clinicaltrials.gov: https://clinicaltrials.gov/ct2/show/NCT03402659.
About neflamapimod (VX-745) and p38 MAPKa Neflamapimod (formerly VX-745) is a brain-penetrant oral small molecule that inhibits the intra-cellular enzyme p38 MAP kinase alpha (p38a). p38a, which is expressed in neurons under conditions of stress and disease, plays a major role in inflammation and/or amyloid beta induced synaptic toxicity, including the impairment of synaptic function (specifically synaptic plasticity). Synaptic plasticity is known to be a major driver of the development of deficits in learning and memory formation that are defining characteristics of Alzheimer's disease. Further information on neflamapimod and p38a was published in November 2017 as a review in the Journal of Prevention of Alzheimer's Disease (JPAD): https://doi.org/10.14283/jpad.2017.41
Neflamapimod was discovered by Vertex Pharmaceuticals Incorporated and licensed by EIP Pharma LLC in 2014.
About EIP Pharma LLC EIP Pharma LLC (www.eippharma.com) is a private, Cambridge, MA-based company advancing CNS-focused therapeutics for improved patient benefit. For more information please visit www.eippharma.com.
Comment P2a only had 16 participants. It is also a plaque attack drug.
11
Not yet recruiting Safety, Feasibility, Tolerability, and Efficacy of a New Buccal Film of Montelukast in Patients With Mild to Moderate Alzheimer's Disease Alzheimer Disease Drug: Montelukast new buccal film Other: Placebo buccal film
Case Series Using Montelukast in Patients with Memory Loss and ... https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5420184/ by SI Rozin - ?2017 - ?Related articlesJan 31, 2017 - Patients with dementia were noted by family members to be less agitated, but had no memory improvement at the doses used. Montelukast may be useful to treat memory impairment and dementia. Long term use might act as a prophylactic to prevent dementia. Keywords: Alzheimer's, Cognitive impairment, ... ?Abstract · ?INTRODUCTION · ?RESULTS · ?DISCUSSION Safety, Feasibility, Tolerability, and Efficacy of a New Buccal Film of ... https://clinicaltrials.gov/ct2/show/NCT03402503
Jan 18, 2018 - Official Title: A Randomized Phase IIa, Multi-center, Double-blind, Placebo-controlled Study to Assess the Safety, Feasibility, Tolerability, and Efficacy of a New Buccal Film of Montelukast in Patients With Mild to Moderate Alzheimer's Disease. Anticipated Study Start Date : February 19, 2018. Estimated ... IntelGenx on go in Canada to launch mid-stage study of Montelukast ... https://seekingalpha.com/.../3318655-intelgenx-go-canada-launch-mid-stage-study-m...
Dec 15, 2017 - Health Canada has signed off on a Phase 2a proof-of-concept study assessing IntelGenx's (OTCQX:IGXT +4.6%) Montelukast VersaFilm in patients with mild-to-moderate Alzheimer's disease (AD). Patient screening should commence next quarter. The 70-subject, randomized, double-blind, ...
12
Recruiting A Study of Crenezumab Versus Placebo to Evaluate the Efficacy and Safety in Participants With Prodromal to Mild Alzheimer's Disease (AD) Alzheimer's Disease Drug: Crenezumab Drug: Placebo Imaging End Points Clinical Research Scottsdale, Arizona, United States Radiant Research, Inc. Tempe, Arizona, United States University of Arizona Tucson, Arizona, United States (and 314 more...)
Crenezumab | ALZFORUM https://www.alzforum.org/therapeutics/crenezumab Crenezumab is a passive immunotherapy approach in which patients are treated with monoclonal antibodies that specifically recognize Aß peptides. Crenezumab recognizes multiple forms of aggregated Aß, including oligomeric and fibrillar species and amyloid plaques with high affinity, and monomeric Aß with low affinity. Genentech doubles down on its PhIII Alzheimer's campaign for ... https://endpts.com/genentech-doubles-down-on-its-phiii-alzheimers-campaign-for-cre... Feb 28, 2017 - Roche's big biotech group Genentech is doubling down on one of the most prominent drugs in late-stage development for Alzheimer's. The company is launching a second Phase III study of crenezumab, according to its partners at AC Immune $ACIU, in search of positive data in a field littered with the ...
13
Recruiting A Multinational, Multi-center, Randomized, Double-blind, Active Comparator, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Donepezil Transdermal Patch in Patients With Alzheimer's Disease Alzheimer Disease Drug: Donepezil patch Drug: aricept Tab 44sites including Konkuk University Medical Center Seoul, Korea, Republic of
no comment
14
Not yet recruiting Effect of Choline Alphoscerate on Cognitive Function in Alzheimer's Dementia Alzheimer's Disease Drug: Alfoatirin® Tab. + Aripezil® Tab. Drug: Aripezil® Tab. Dong-A University Hospital Busan, Korea, Republic of Gyeongsang National University Hospital Busan, Korea, Republic of Inje University Busan Paik Hospital Busan, Korea, Republic of (and 3 more...)
Overseas Business/Products/Finished Products | YUHAN eng.yuhan.co.kr/OVERSEAS/Products/Finished/?cid=516&Category=529 Anxiolytics, SEDIEL TAB. Tandospirone 5mg. Tandospirone 10mg, Depression and phobia in ... Brain function enhancer, ALFOATIRIN SOFT CAP. Choline alfoscerate 400mg, Secondary symptoms or degeneration due ... Treatment for dementia, ARIPEZIL TAB. Donepezil HCl 5mg. Donepezil HCl 10mg, Treatments of mild, ...
15
Not yet recruiting A Phase IV Study to Evaluate Safety, Tolerability and Effectiveness of Rivastigmine Patch 15cm2 in Patients With Severe Dementia of the Alzheimer's Type. Alzheimer's Disease Drug: Rivastigmine
Rivastigmine - Wikipedia https://en.wikipedia.org/wiki/Rivastigmine Rivastigmine (sold under the trade name Exelon) is a acetylcholinesterase inhibitor used for the treatment of mild to moderate Alzheimer's disease and Parkinson's. Trade names?: ?Exelon Metabolism?: ?Liver?, via pseudocholinesterase Biological half-life?: ?1.5 hours Pregnancy category?: ?US: ?B? (No risk in non-hu...
Rivastigmine: MedlinePlus Drug Information https://medlineplus.gov › Drugs, Herbs and Supplements Feb 15, 2016 - Rivastigmine is also used to treat dementia in people with Parkinson's disease (a brain and nervous system disease with symptoms of slowing of movement, muscle weakness, shuffling walk, and loss of memory). Rivastigmine is in a class of medications called cholinesterase inhibitors.
16
Active, not recruiting A Study of Pimavanserin for the Treatment of Agitation and Aggression in Subjects With Alzheimer's Disease Agitation and Aggression in Alzheimer's Disease Drug: Pimavanserin ATP Clinical Research, Inc. Costa Mesa, California, United States Neuropain Medical Center Fresno, California, United States Neurology Center of North Orange County Fullerton, California, United States (and 38 more...)
Pimavanserin: A new chemical entity for Alzheimer's disease psychosis www.acadia-pharm.com/pipeline/pimavanserin-drp/ Pimavanserin is a proprietary small molecule that we have advanced to Phase 3 development for dementia-related psychosis. Pimavanserin is a selective serotonin inverse agonist (SSIA) preferentially targeting 5-HT2A receptors that are thought to play an important role in dementia-related psychosis.
17
Recruiting NEW A Clinical Study Evaluating the Efficacy and Safety of RPh201 Treatment in Individuals With Alzheimer's Disease With or Without Coexisting Cerebrovascular Disease Mild to Moderate Dementia Due to Alzheimer's Disease With or Without Coexisting Cerebrovascular Disease Drug: RPh201 Other: Placebo Toronto Memory Program Toronto, Ontario, Canada
Safety and Efficacy Study of RPh201 Treatment of Ischemic Optic ... https://clinicaltrials.gov/ct2/show/NCT02045212 Jan 24, 2014 - The study objectives are to assess any changes in visual acuity and visual field observed following the administration of RPh201 during an overall treatment period of at least 13 consecutive weeks with an option to extended the treatment phase to another 13 weeks (26 weeks total), and at the follow-up visit ... Study Type?: ?Interventional (Clinical Trial) Study Completion Date?: ?December 2016 Study Start Date?: ?February 2014 Masking?: ?Triple (Participant, Care Provider, Inv...
RPh 201 - AdisInsight https://adisinsight.springer.com/drugs/800034933 Mar 16, 2018 - Regenera Pharma is developing RPh 201, a proprietary formulation of a well-defined and characterised botanical drug. The company is focusing on ischaemic optic neuropathy, and will later select additional neurodegenerative indications (e.g glaucoma) for further clinical development. A phase II trial is ...
18
Recruiting Clinical Trial to Evaluate the Efficacy and Safety of GV1001 in Alzheimer Patients Alzheimer Disease Drug: Normal Saline 0.9% Drug: GV1001 0.56 mg Drug: GV1001 1.12 mg Hanyang University Guri Hospital Guri-si, Gyunggi-do, Korea, Republic of
Cancer vaccination with telomerase peptide GV1001. - NCBI https://www.ncbi.nlm.nih.gov/pubmed/19388882 by JA Kyte - ?2009 - ?Cited by 70 - ?Related articlesExpert Opin Investig Drugs. 2009 May;18(5):687-94. doi: 10.1517/13543780902897631 . Cancer vaccination with telomerase peptide GV1001. Kyte JA(1). Author information: (1)Department of Clinical Cancer Research, The Norwegian Radium Hospital, Oslo University Hospital, 0310 Oslo, Norway. jon.amund.kyte@rr ... GV1001 - Biote
HUH????
19
Recruiting Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IONIS-MAPTRx in Patients With Mild Alzheimer's Disease Mild Alzheimer's Disease Drug: IONIS MAPTRx Other: Placebo Montreal Neurological Hospital Montréal, Canada Clinical Research Services Turku CRST Turku, Finland Charite - Universitaetsmedizin Berlin Campus Mitte Berlin, Germany (and 9 more...)
Alzheimer's Therapy IONIS-RAPRTx Begins Phase 1/2 Clinical Trial https://alzheimersnewstoday.com/.../ionis-pharmaceuticals-starts-phase-1-and-2-clinica... Oct 17, 2017 - Ionis Pharmaceuticals has started a Phase 1/2 clinical trial to evaluate the Alzheimer's therapy IONIS-MAPTRx. IONIS-MAPTRx is aimed at reducing the production of tau protein, whose accumulation in the brain is a hallmark of the disease. The trial will evaluate the therapy in patients with mild forms of ...
IONIS MAPTRx - AdisInsight https://adisinsight.springer.com/drugs/800049748 Ionis Pharmaceuticals (formerly Isis Pharmaceuticals) is developing IONIS-MAPTRx (also known as BIIB 080), an antisense oligonucleotide, that is expected to reduce production of the tau protein and its accumulation in the brain cells, for the treatment of Alzheimer's disease, including patients with frontotemporal dementia.
Biogen Pays Ionis $10M as Phase I/IIa Trial Launched for Alzheimer's ... https://www.genengnews.com/gen-news...pays-ionis...ionis-maptrx/81255048 Oct 13, 2017 - Biogen Pays Ionis $10M as Phase I/IIa Trial Launched for Alzheimer's Candidate IONIS-MAPTRx. Alex Philippidis. Ionis Pharmaceuticals said today it has received a $10 million milestone payment from Biogen for launching a Phase I/IIa trial of the antisense drug the companies are codeveloping for mild ...
20
Recruiting NEW Safety and Immunogenicity of Repeated Doses of ABvac40 in Patients With a-MCI or Vm-AD Mild Cognitive Impairment Alzheimer Disease Biological: ABvac40 Biological: Placebo CHU de Montpellier Montpellier, France Centre de Recherche Clinique du Gérontopôle Toulouse, France San Giovanni di Dio - Fatebenefratelli Brescia, Italy (and 17 more...)
ABvac 40 | ALZFORUM https://www.alzforum.org/therapeutics/abvac-40 Jan 29, 2018 - Overview. Name: ABvac 40. Therapy Type: Immunotherapy (active) (timeline) Target Type: Amyloid-Related (timeline) Condition(s): Alzheimer's Disease U.S. FDA Status: Alzheimer's Disease (Phase 2) Company: Araclon Biotech. Background. ABvac40 is an investigational vaccine targeting the C ... Safety, tolerability and immunogenicity of an active anti-Aß40 vaccine ... https://www.ncbi.nlm.nih.gov/pubmed/29378651 by AM Lacosta - ?2018 Alzheimers Res Ther. 2018 Jan 29;10(1):12. doi: 10.1186/s13195-018-0340-8. Safety, tolerability and immunogenicity of an active anti-Aß40 vaccine (ABvac40) in patients with Alzheimer's disease: a randomised, double-blind, placebo-controlled, phase I trial. Lacosta AM(1), Pascual-Lucas M(1), Pesini P(2), Casabona ...
21
Recruiting NEW Tau Screening Study in Subjects With Early Symptomatic AD Alzheimer Disease Drug: 18F-AV-1451 Irvine Center for Clinical Research Irvine, California, United States Brain Matters Research Delray Beach, Florida, United States Neuropsychiatric Research Center of Southwest Florida Fort Myers, Florida, United States (and 5 more...)
[color=red] Note: this is a screening trial not a treatment trial.
18F-AV-1451 tau PET imaging correlates strongly with tau ... https://academic.oup.com/brain/article/139/9/2372/1744745 by R Smith - ?2016 - ?Cited by 47 - ?Related articlesJun 29, 2016 - We performed tau positron emission tomography imaging with 18F-AV-1451 in three patients harbouring a p.R406W mutation in the MAPT gene, encoding tau. This mutation results in 3- and 4-repeat tau aggregates similar to those in Alzheimer's disease, and many of the mutation carriers initially suffer ...
?Introduction · ?Materials and methods · ?Results · ?Discussion Head to head comparison of [18F] AV-1451 and [18F] THK5351 for tau ... https://www.ncbi.nlm.nih.gov/pubmed/29143870 by YK Jang - ?2017 - ?Cited by 2 - ?Related articlesEur J Nucl Med Mol Imaging. 2018 Mar;45(3):432-442. doi: 10.1007/s00259-017-3876-0. Epub 2017 Nov 16. Head to head comparison of [18F] AV-1451 and [18F] THK5351 for tau imaging in Alzheimer's disease and frontotemporal dementia. Jang YK(1)(2), Lyoo CH(3), Park S(1), Oh SJ(4), Cho H(3), Oh M(4), Ryu YH(5), ...[/color]
22
Recruiting Tau Screening Study in Patients With Early Symptomatic AD Alzheimer Disease Drug: 18F-AV-1451 Pacific Research Network San Diego, California, United States Syrentis Clinical Research Santa Ana, California, United States Brain Matters Research Delray Beach, Florida, United States (and 7 more...)
See item 21
23
Recruiting Assessment of the Efficacy, Safety, and Tolerability of AVP-786 (Deudextromethorphan Hydrobromide [d6 DM]/Quinidine Sulfate [Q]) for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type Agitation in Patients With Dementia of the Alzheimer's Type Drug: Placebo Drug: AVP-786 Australian Alzheimer's Research Foundation Nedlands, Australia Neuro Trials Victoria Pty Ltd Noble Park, Australia Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz Nyíregyháza, Hungary
AVP-786 | ALZFORUM https://www.alzforum.org/therapeutics/avp-786 Overview. Name: AVP-786. Therapy Type: Small Molecule (timeline) Target Type: Other Neurotransmitters (timeline) Condition(s): Alzheimer's Disease, Schizophrenia U.S. FDA Status: Alzheimer's Disease (Phase 3), Schizophrenia (Phase 2) Company: Avanir Pharmaceuticals, Concert Pharmaceuticals, Inc., Otsuka ... Avanir Pharmaceuticals Announces Initiation of Phase III Trial of AVP ... https://www.avanir.com/.../avanir-pharmaceuticals-announces-initiation-phase-iii-trial-... Nov 16, 2015 - ALISO VIEJO, Calif., November 16, 2015-Avanir Pharmaceuticals, Inc. today announced initiation of enrollment into a phase III clinical trial evaluating AVP-786 for the treatment of agitation in patients with Alzheimer’s disease. ... Avanir Pharmaceuticals recently received Fast ...
24
Recruiting Safety, Tolerability, PK and PD of Posiphen® in Subjects With Early Alzheimer's Disease Alzheimer's Disease Drug: Posiphen Drug: Placebo UCSD Alzheimer's Disease Research Center La Jolla, California, United States IU Health Partners, Adult Neurology Clinic Indianapolis, Indiana, United States Washington University Sleep Medicine Center Brentwood, Missouri, United States
QR Pharma, Inc | INNOVATION qrpharma.com/innovation/ QR Pharma's lead compound, Posiphen® inhibits synthesis of amyloid precursor protein (APP), tau and a-Synuclein; it is distinct from other Alzheimer's disease drugs currently in development, because it inhibits the formation of several toxic proteins, rather than removing individual toxic protein after they are produced.
Oct 6, 2016 - Posiphen®, which was discovered by the US National Institute on Aging (NIA) is a small, orally active, experimental drug that specifically inhibits the synthesis of amyloid precursor protein (APP), Tau and a-Synuclein. It is distinct from other Alzheimer's disease drugs currently in development, because it ... Study Type?: ?Interventional (Clinical Trial) Estimated Study Completion Date?: ?December ... Actual Study Start Date?: ?March 2, 2017 Posiphen as a Well-tolerated Alp
25
Recruiting A Study to Evaluate the Safety and Efficacy of AstroStem in Treatment of Alzheimer's Disease Alzheimer Disease Drug: AstroStem Other: Placebo-Control ATP Clinical Research Costa Mesa, California, United States Syrentis Clinical Research Santa Ana, California, United States Valden Medical Honolulu, Hawaii, United States
Mar 10, 2017 - SEOUL, South Korea--(BUSINESS WIRE)--Biotechnology enterprise Nature Cell (KOSDAQ:007390) announced that it had started to recruit patients for its clinical trials of ‘ASTROSTEM,’ a stem cell drug for Alzheimer's disease treatment, in the U.S. ... The phase I and II clinical ...
Alzheimer's disease | Biostar Stemcell Research Institute www.stemcellbio.com/alzheimers-disease/ Approved by Ministry of Health, Labor and Welfare of Japan. AstroStem was approved for regenerative medical treatment for autoimmune disease from Japan Health and Welfare Ministry in 2015, and is currently being treated at a local hospital in Japan.
Spinal injury | Biostar Stemcell Research Institute www.stemcellbio.com/??????/ About AstroStem. AstroStem is an autologous adipose tissue derived stem cell injected through veins. Through the homing effect, one of the unique characteristics of stem cells, they move to the affected lesion to directly differentiate, or interact with the area causing the trophic effect or paracrine effect.
Mar 10, 2017 - Nature Cell announced that it had started to recruit patients for its clinical trials of 'ASTROSTEM,' a stem cell drug for Alzheimer's disease treatment, in the U.S. The phase I and II clinical trials regarding Alzheimer's disease were approved by the U.S. FDA on November 24, 2016. In February 2017, IRB ... Nature Cell to
26
Recruiting Addressing Dementia Via Agitation-Centered Evaluation Agitation in Patients With Dementia of the Alzheimer's Type Alzheimer Disease Agitation,Psychomotor Drug: AXS-05 Drug: Bupropion Drug: Placebo Axsome study site Costa Mesa, California, United States Axsome study site Fresno, California, United States Axsome study site Long Beach, California, United States (and 27 more...)
Axsome Therapeutics About AXS-05 axsome.com/axs-05/about-axs-05/ AXS-05 is a novel, oral, investigational drug product under development for the treatment of central nervous system (CNS) disorders. AXS-05 utilizes Axsome's technology of combining bupropion and dextromethorphan (DM). DM is an NMDA receptor antagonist, sigma-1 receptor agonist, and inhibitor of the serotonin and ...
Axsome Therapeutics Treatment Resistant Depression (TRD) axsome.com/axs-05/treatment-resistant-depression-trd/ AXS-05 utilizes Axsome's technology of combining bupropion and dextromethorphan. Dextromethorphan is an NMDA receptor antagonist, sigma-1 receptor agonist, and inhibitor of the serotonin and norepinephrine transporters. Bupropion serves to increase the bioavailability of dextromethorphan, and is a norepinephrine ...
Axsome Therapeutics Agitation in Patients with Alzheimer's Disease ... axsome.com/axs-05/agitation-in-patients-with-alzheimers-disease-ad/ AXS-05 utilizes Axsome's technology of combining bupropion and dextromethorphan. Dextromethorphan is an NMDA receptor antagonist, sigma-1 receptor agonist, and inhibitor of the serotonin and norepinephrine transporters. Bupropion serves to increase the bioavailability of dextromethorphan, and is a norepinephrine ... Axsome Therapeutics Overview & Pipe
27
Recruiting Octohydroaminoacridine Succinate Tablet for Mild-to-Moderate Alzheimer's Disease Alzheimer Disease Drug: Octohydroaminoacridine Succinate Drug: Aricept Drug: Placebos Shanghai Mental Health Center Shanghai, Shanghai, China
Octohydroaminoacridine Succinate Tablet for Mild-to-Moderate ... https://clinicaltrials.gov/ct2/show/NCT03283059 Sep 14, 2017 - Inhibition of acetylcholinesterase has been a effective treatment for Alzheimer's disease. Octohydroaminoacridine, a new acetylcholinesterase inhibitor, is a potential treatment for Alzheimer's disease. The investigators conducted a 26 weeks, randomized, double-blind, double-dummy, placebo- and ...
Study of Octohydroaminoacridine Succinate Tablets in Patients With ... https://clinicaltrials.gov/ct2/show/NCT01569516 Apr 3, 2012 - The purpose of this study is a preliminary assessment of the Octohydroaminoacridine Succinate tablets in the treatment of mild to moderate Alzheimer's disease and explore the efficacy and safety of the best dose. The 288 patients were randomly assigned to four groups: high dose (4mg / time), moderate ...
Now being tried in combo with Donepezil - in trials since 2012
28
Recruiting S-Equol in Alzheimer's Disease 2 Trial Alzheimer Disease Drug: S-equol Other: Placebo Clinical and Translational Science Unit Fairway, Kansas, United States University of Kansas Medical Center Kansas City, Kansas, United States
S-Equol | ALZFORUM https://www.alzforum.org/therapeutics/s-equol S-Equol is a selective agonist of the estrogen receptor-ß, which is expressed on mitochondria. ... Unlike estrogen receptor-a, which is expressed in the uterus and breast, ER-ß is more strongly expressed in the brain.
A Mitochondrial Biomarker-Based Study of S-Equol in Alzheimer's ... https://www.ncbi.nlm.nih.gov/pubmed/28598847 by HM Wilkins - ?2017 - ?Cited by 2 - ?Related articlesA Mitochondrial Biomarker-Based Study of S-Equol in Alzheimer's Disease Subjects: Results of a Single-Arm, Pilot Trial. ... Reductions in bioenergetic fluxes, mitochondrial enzyme activities, and mitochondrial number are observed in Alzheimer's disease (AD).
S-Equol in Alzheimer's Disease 2 Trial - Full Text View - ClinicalTrials ... https://clinicaltrials.gov/ct2/show/NCT03101085 Intervention Model: Crossover Assignment. Masking: Double (Participant, Investigator). Primary Purpose: Treatment. Official Title: S-Equol in Alzheimer's Disease 2 (SEAD2) Trial. Actual Study Start Date : May 5, 2017. Estimated Primary Completion Date : September 30, 2019. Estimated Study Completion Date : October 30, ...
S-Equol in Alzheimer's Disease (SEAD) Trial - Full Text View ... https://clinicaltrials.gov/ct2/show/NCT02142777 May 20, 2014 - S-Equol in Alzheimer's Disease (SEAD) Trial (SEAD) ... In this study, it is believed that by targeting mitochondria, we might learn more about its influence on AD symptoms. Mitochondria have a receptor site for estrogen (a hormone) called estrogen receptor ß (ERß).
29
Recruiting Study of LM11A-31-BHS in Mild-moderate AD Patients Mild to Moderate Alzheimer's Disease Drug: 400mg LM11A-31-BHS Drug: 800mg LM11A-31-BHS Drug: Placebos University Hospital Graz Graz, Styria, Austria Landeskrankenhaus Hall Hall in Tirol, Tirol, Austria Charles University Praha, Hlavni mesto PRAHA, Czech Republic (and 9 more...)
Study of LM11A-31-BHS in Mild-moderate AD Patients | Clinical ... https://www.centerwatch.com/.../mild-to-moderate-alzheimers-disease-study-lm11a-31... Detailed Study Description. The goal of this AD Pilot is to conduct a prospective, double-blind, multicenter, phase IIa exploratory safety, feasibility and proof-of-concept trial in mild to moderate Alzheimer's disease patients with the orally bioavailable p75 neurotrophin receptor ligand LM11A-31-BHS dosed twice daily for 26 ...
A Small Molecule p75NTR Ligand, LM11A-31, Reverses ... - PLOS journals.plos.org/plosone/article?id=10.1371/journal.pone.0102136 by DA Simmons - ?2014 - ?Cited by 19 - ?Related articlesAug 25, 2014 - Previous work found that a lead p75NTR ligand, LM11A-31, prevents degeneration of cholinergic neurites when given to an AD mouse model in the early stages of disease pathology. To extend its potential clinical applications, we sought to determine whether LM11A-31 could reverse cholinergic neurite ... ?Abstract · ?Materials and Methods · ?Results · ?Discussion
Research Grants - 2013 - Alzheimer's Association https://www.alz.org/research/alzheimers_grants/for.../overview-2013.asp?grants... Dr. Longo and colleagues at Pharmatrophix, Inc. have planned a multipart, phase I trial of a drug known as LM11A-31-BHS, which inhibits P75 signaling. The purposes of the trial are to determine the doses of the drug that can be used safely in humans, and to study how the human body disposes of the drug. Participants in ...
30
Recruiting Follow-up Study of Safety and Efficacy in Subjects Who Completed NEUROSTEM® Phase-I/IIa Clinical Trial. Alzheimer's Disease Biological: human umbilical cord blood derived mesenchymal stem cells Other: Normal saline 2mL Samsung Medical Center Seoul, Korea, Republic of
Follow-up Study of Safety and Efficacy in Subjects ... - Clinical Trials.gov https://clinicaltrials.gov/ct2/show/NCT03172117 Jun 1, 2017 - Primary Purpose: Treatment. Official Title: Follow-up Study of Safety and Efficacy in Subjects Who Completed NEUROSTEM® Phase-I/IIa Clinical Trial. Actual Study Start Date : May 19, 2017. Estimated Primary Completion Date : December 31, 2021. Estimated Study Completion Date : December 31, 2021 ...
31
Recruiting A Phase II Study to Assess the Safety, Tolerability and Efficacy of Xanamem™ in Subjects With Mild Dementia Due to AD (XanADu) Dementia Drug: Xanamem™ Drug: Placebo (for Xanamem™) National Research Institute Los Angeles, California, United States PCND Neuroscience Research Institute Poway, California, United States Northern California Research Sacramento, California, United States (and 19 more...)
Xanamem - Actinogen actinogen.com.au/xanamem/ XANAMEM ™ ... Xanamem has been developed in response to evidence that there is a strong association between chronically raised cortisol levels in the blood and in the ... In a mouse model of Alzheimer's disease, Xanamem was effective in improving cognitive function and in clearing amyloid plaques from the brain.
Xanamem for Mild Alzheimer's Disease - National Institute on Aging https://www.nia.nih.gov/alzheimers/clinical-trials/xanamem-mild-alzheimers-disease ClinicalTrials.gov ID: NCT02727699. Official Title: XanADu: A Phase II, Double-Blind, 12-Week, Randomised, Placebo-Controlled Study to Assess the Safety, Tolerability and Efficacy of Xanamem™ in Subjects With Mild Dementia Due to Alzheimer's Disease (AD) ...
(11ß-HSD1) inhibitor UE2343 (Xanamem™). - NCBI https://www.ncbi.nlm.nih.gov/pubmed/28012176 by SP Webster - ?2017 - ?Cited by 2 - ?Related articlesJan 25, 2017 - Selection and early clinical evaluation of the brain-penetrant 11ß-hydroxysteroid dehydrogenase type 1 (11ß-HSD1) inhibitor UE2343 (Xanamem™). Webster SP(1), McBride A(1), Binnie M(1), Sooy K(1), Seckl JR(1), Andrew R(1), Pallin TD(2), Hunt HJ(3), Perrior TR(4), Ruffles VS(5), Ketelbey JW(5), Boyd ...
32
Recruiting Relapse Prevention Study of Pimavanserin in Dementia-related Psychosis Dementia-related Psychosis Drug: Placebo Drug: Pimavanserin 34 mg Drug: Pimavanserin 20 mg ATP Clinical Research Inc. Costa Mesa, California, United States The Parkinson's and Movement Disorder Institute Fountain Valley, California, United States Neuro-Pain Medical Center Fresno, California, United States
Pimavanserin - Wikipedia https://en.wikipedia.org/wiki/Pimavanserin Pimavanserin, sold under the brand name Nuplazid, is an atypical antipsychotic which is approved for the treatment of Parkinson's disease psychosis and is also under development for the treatment of schizophrenia, agitation, and major depressive disorder.
Pimavanserin: A new chemical entity for Alzheimer's disease psychosis www.acadia-pharm.com/pipeline/pimavanserin-drp/ Pimavanserin is a proprietary small molecule that we have advanced to Phase 3 development for dementia-related psychosis. Pimavanserin is a selective serotonin inverse agonist (SSIA) preferentially targeting 5-HT2A receptors that are thought to play an important role in dementia-related psychosis.
