Here's that Servier trial with CX-1632 (S47445) in Alzheimer's patients with Depressive symptoms. Nice size trial enrolling 500 patients, 3 different doses, running 24 weeks with plans for a 28 week extension to evaluate the drug in combo with Aricept. The trial is still listed as enrolling on Clinicaltrials.gov, but Neuro indicated that the trial had failed on efficacy -
>>> Efficacy and Safety of 3 Doses of S47445 Versus Placebo in Patients With Alzheimer's Disease at Mild to Moderate Stages With Depressive Symptoms
This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2015 by Servier
Sponsor:
Institut de Recherches Internationales Servier
Information provided by (Responsible Party):
Servier ( Institut de Recherches Internationales Servier )
ClinicalTrials.gov Identifier:
NCT02626572
First received: November 4, 2015
Last updated: December 7, 2015
Last verified: December 2015
History of Changes
Purpose
The purpose of this trial is to assess the efficacy and safety of S47445 versus placebo in patients with Alzheimer's disease at mild to moderate stages with depressive symptoms. An optional 28-week extension period will be performed to evaluate safety/tolerance and efficacy of S47445 in co-administration with donepezil.
Condition
Intervention
Phase
Alzheimer's Disease
Drug: S47445 5mg
Drug: S47445 15mg
Drug: S47445 50mg
Drug: Placebo
Phase 2
Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of 3 Doses of S47445 Versus Placebo in Patients With Alzheimer's Disease at Mild to Moderate Stages With Depressive Symptoms. A 24-week International, Multi-centre, Randomized, Double-blind, Placebo-controlled Phase II Study in Monotherapy Followed by an Optional 28-week Extension Period in Co-administration With Donepezil.
Resource links provided by NLM:
Genetics Home Reference related topics: Alzheimer disease
MedlinePlus related topics: Alzheimer's Disease
Genetic and Rare Diseases Information Center resources: Familial Alzheimer Disease
U.S. FDA Resources
Further study details as provided by Servier:
Primary Outcome Measures: •Change from baseline on 11-item ADAS-Cog [ Time Frame: 24 weeks of treatment ] [ Designated as safety issue: No ]
Cognition criterion
Secondary Outcome Measures: •Activities of Daily Living: Disability Assessment for Dementia (DAD) [ Time Frame: baseline, week 12, week 24 and week 52 ] [ Designated as safety issue: No ]
Key secondary efficacy criterion
•Cognition: 13-item ADAS-Cog [ Time Frame: baseline, week 4, week 12, week 24, week 38 and week 52 ] [ Designated as safety issue: No ]
Other secondary efficacy criteria
•Cognition: Mini-Mental State Examination (MMSE) [ Time Frame: baseline, week 12, week 24 and week 52 ] [ Designated as safety issue: No ]
Other secondary efficacy criteria
•Depressive symptoms: Cornell Scale for Depression in Dementia (CSDD) [ Time Frame: baseline, week 4, week 12, week 24, week 38 and week 52 ] [ Designated as safety issue: No ]
Other secondary efficacy criteria
•Behavioural signs and symptoms: Neuropsychiatric Inventory (NPI) [ Time Frame: baseline, week 4, week 12, week 24 and week 52 ] [ Designated as safety issue: No ]
Other secondary efficacy criteria
•Global Clinic Assessment of Change: Alzheimer's Disease Cooperative Studies-Clinical Global Impression of Change (ADCS-CGIC) [ Time Frame: baseline, week 24 and week 52 ] [ Designated as safety issue: No ]
Other secondary efficacy criteria
•Functionality: Gait task (GT), measure of speed of walking (unit= meters/ seconds) [ Time Frame: baseline, week 4, week 12, week 24, week 38 and week 52 ] [ Designated as safety issue: No ]
Other secondary efficacy criteria
•Adverse events [ Time Frame: through study completion, an average of 1 year ] [ Designated as safety issue: No ]
Safety criterion
•Vital signs: heart rate [ Time Frame: baseline, week 4, week 12, week 24, week 38 and week 52 ] [ Designated as safety issue: No ]
Safety criterion
•Vital signs: body temperature [ Time Frame: baseline, week 4, week 12, week 24, week 38 and week 52 ] [ Designated as safety issue: No ]
Safety criterion
•Vital signs: blood pressure [ Time Frame: baseline, week 4, week 12, week 24, week 38 and week 52 ] [ Designated as safety issue: No ]
Safety criterion
•Vital signs: body weight [ Time Frame: baseline, week 12, week 24, week 38 and week 52 ] [ Designated as safety issue: No ]
Safety criterion
•12-lead ECG [ Time Frame: baseline, week 4, week 12, week 24, week 38 and week 52 ] [ Designated as safety issue: No ]
Safety criterion
•Biological laboratory parameters: number of participants with abnomal laboratory values [ Time Frame: baseline, week 4, week 12, week 24, week 38 and week 52 ] [ Designated as safety issue: No ]
Safety criterion
•Cornell Scale for Depression in Dementia (CSDD, suicide item - item 16) [ Time Frame: baseline, week 4, week 12, week 24, week 28, week 38 and week 52 ] [ Designated as safety issue: No ]
Safety criterion
Estimated Enrollment: 500
Study Start Date: February 2015
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Arms
Assigned Interventions
Experimental: S47445 5mg Drug: S47445 5mg
S47445 5 mg tablets taken orally once a day during breakfast, starting the day after inclusion visit and ending the day of the W024 visit (main period) or starting the day after inclusion visit and ending the day of the W052 visit (period including main period and optional extension period).
Experimental: S47445 15mg Drug: S47445 15mg
S47445 15 mg tablets taken orally once a day during breakfast, starting the day after inclusion visit and ending the day of the W024 visit (main period) or starting the day after inclusion visit and ending the day of the W052 visit (period including main period and optional extension period).
Experimental: S47445 50mg Drug: S47445 50mg
S47445 50 mg tablets taken orally once a day during breakfast, starting the day after inclusion visit and ending the day of the W024 visit (main period) or starting the day after inclusion visit and ending the day of the W052 visit (period including main period and optional extension period).
Placebo Comparator: Placebo Drug: Placebo
Placebo tablets taken orally once a day during breakfast, starting the day after inclusion visit and ending the day of the W024 visit (main period) or starting the day after inclusion visit and ending the day of the W052 visit (period including main period and optional extension period).
Eligibility
Ages Eligible for Study: 55 Years to 85 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria:
•Out-patients
•Able to perform neuropsychological tests
•Have a responsible informant
•DSM-IV-TR criteria for Dementia of the Alzheimer's Disease Type
•Mini mental State Examination (MMSE) = 15-24 both inclusive
•National Institute of Mental Health (NIMH) provisional criteria for depression in AD (NIMH-dAD)
•Cornell Scale for Depression in Dementia total score > or = 8
•Patients who have never been treated with AD treatments or patients who have stopped AD treatment whatever the reason
•Patients either not currently treated with an antidepressant or patients being treated with an antidepressant at the recommended dose for at least 8 weeks without clinical efficacy, who can stop this treatment according to the investigator's opinion.
Exclusion Criteria:
•Patients not able to read or write
•Patients having participated in a study testing disease modifying therapy for AD, or in another study with administration of investigational drug or device within the previous 3 months prior to selection visit
•Depressive symptoms that, in investigator's judgment, are clearly due to a medical condition other than AD, or are a direct result of non-mood related dementia symptoms
•History of epilepsy or solitary seizure
•Medical history of Major Depressive Disorder more than 3 years before onset of the disease, treated with antidepressive drugs or electroconvulsive therapy
•Severe or unstable disease of any type that could interfere with safety and efficacy assessments
•Alcohol abuse or drug abuse or addiction, as judged by the clinician (excluding nicotine)
•Clinically relevant lactose intolerance
•Antidepressant treatment not stopped for at least 3 weeks before inclusion
•Significant worsening of depressive symptoms or high suicidal risk according to investigator's judgment
•For optional extension phase: medically instable Chronic Obstructive Pulmonary Disease and asthma, known hypersensitivity to donepezil hydrochloride or piperidine derivatives
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02626572
Contacts
Contact: Institut de Recherches Internationales Servier clinicaltrials@servier.com
Show 82 Study Locations
Sponsors and Collaborators
Institut de Recherches Internationales Servier
More Information
No publications provided
Responsible Party: Servier ( Institut de Recherches Internationales Servier )
ClinicalTrials.gov Identifier: NCT02626572 History of Changes
Other Study ID Numbers: CL2-47445-011 2014-001519-38
Study First Received: November 4, 2015
Last Updated: December 7, 2015
Health Authority: Brazil: Ministry of Health
Bulgaria: Bulgarian Drug Agency
Chile: Ministry of Health
Czech Republic: State Institute for Drug Control
Germany: Federal Institute for Drugs and Medical Devices
Hungary: National Institute of Pharmacy
Japan: Pharmaceuticals and Medical Devices Agency
Mexico: Ministry of Health
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Russia: Ministry of Health of the Russian Federation
South Africa: Medicines Control Council
Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Dementia
Mental Disorders
Nervous System Diseases
Neurodegenerative Diseases
Tauopathies
ClinicalTrials.gov processed this record on January 13, 2016
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