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Open for thoughts and rebuttals.

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Anavex Life Sciences Announces Publication of Foundational Data for ANAVEX®2-73 (blarcamesine) in Multiple Sclerosis (MS) GlobeNewswire Inc. - 2/24/2020 7:00:10 AM
Proxy Statement (definitive) (def 14a) Edgar (US Regulatory) - 2/20/2020 4:32:14 PM
Amended Statement of Ownership (sc 13g/a) Edgar (US Regulatory) - 2/14/2020 4:38:56 PM
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Anavex Life Sciences Reports Fiscal 2020 First Quarter Financial Results and Provides Clinical Study Updates GlobeNewswire Inc. - 2/6/2020 7:00:10 AM
Anavex Life Sciences to Present and Participate in a Panel at the 2020 BIO CEO & Investor Conference GlobeNewswire Inc. - 2/4/2020 7:00:10 AM
Anavex Life Sciences Announces Fast Track Designation Granted by U.S. FDA for ANAVEX®2-73 (blarcamesine) Clinical Developmen... GlobeNewswire Inc. - 2/3/2020 7:00:10 AM
Anavex Life Sciences to Announce Fiscal 2020 First Quarter Financial Results on Thursday, February 6th, 2020 GlobeNewswire Inc. - 1/30/2020 7:00:10 AM
Anavex Life Sciences Announces Achievement of Enrollment Target for the ANAVEX®2-73 (blarcamesine) Phase 2 Parkinson’s Dis... GlobeNewswire Inc. - 1/27/2020 7:00:10 AM
Anavex Life Sciences Issued New U.S. Patent for ANAVEX®2-73 Treatment of Neurodevelopmental Disorders including Rett Syndrom... GlobeNewswire Inc. - 1/8/2020 7:00:10 AM
Anavex Life Sciences Reports Fiscal Year 2019 Financial Results And Provides Clinical Study Updates GlobeNewswire Inc. - 12/16/2019 7:00:10 AM
Anavex Life Sciences to Announce Fiscal 2019 Year End Financial Results on Monday December 16, 2019 GlobeNewswire Inc. - 12/10/2019 7:00:10 AM
Citation Growth Corp. (OTCQX: CGOTF) Weathering the Cannabis Downturn InvestorsHub NewsWire - 12/9/2019 7:23:11 AM
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Anavex Life Sciences Presents ANAVEX®2-73 (blarcamesine) Data at 12th Clinical Trials on Alzheimer's Disease (CTAD) 2019 Con... GlobeNewswire Inc. - 12/4/2019 7:00:10 AM
Anavex Life Sciences Receives Rare Pediatric Disease Designation from FDA for ANAVEX®2-73 (blarcamesine) for the Treatment o... GlobeNewswire Inc. - 11/14/2019 7:00:00 AM
Anavex Life Sciences Announces Publication of Foundational Data for ANAVEX®2-73 (blarcamesine) in Rett Syndrome GlobeNewswire Inc. - 11/6/2019 7:00:00 AM
Anavex Life Sciences Announces ATTENTION-AD ANAVEX®2-73 Extension Clinical Study in Early Alzheimer’s Disease GlobeNewswire Inc. - 10/9/2019 7:00:00 AM
Anavex Life Sciences Issued New U.S. Patent for Composition of Matter Covering ANAVEX®2-73 for the Treatment of Alzheimer’... GlobeNewswire Inc. - 10/2/2019 7:00:00 AM
Anavex Life Sciences Presented at the 6th Annual European Rett Syndrome Conference Preliminary Clinical Efficacy Data from th... GlobeNewswire Inc. - 9/27/2019 3:00:00 AM
Anavex Life Sciences to Present at the 2019 Cantor Fitzgerald Global Healthcare Conference GlobeNewswire Inc. - 9/26/2019 7:00:00 AM
Notice of Effectiveness (effect) Edgar (US Regulatory) - 9/23/2019 6:35:19 AM
Anavex Life Sciences to Present at the Ladenburg Thalmann 2019 Healthcare Conference GlobeNewswire Inc. - 9/18/2019 7:00:00 AM
Post-effective Amendment to Registration Statement (pos Am) Edgar (US Regulatory) - 9/17/2019 5:16:10 PM
Doc328   Monday, 05/20/19 10:06:34 AM
Re: Biostockclub post# 193371
Post # of 238518 
Quote:
Open for thoughts and rebuttals.



ERP/EEG is not part of the study


From clinicaltrials.gov:


Primary Outcome Measures :
ADAS-Cog (Alzheimer Disease Assessment Scale-Cognition) [ Time Frame: 48 weeks ]
Change from baseline to week 48 in cognition according to the Alzheimer Disease Assessment Scale-Cognition (ADAS-Cog) compared to placebo

ADCS-ADL (Activities of Daily Living) [ Time Frame: 48 weeks ]
Changes from baseline to week 48 in ability to perform daily activities according to the Activities of Daily Living Scale (ADCS-ADL) compared to placebo


Secondary Outcome Measures :
Number of participants with treatment-related adverse events as assessed by CTCAE v4.03 [ Time Frame: 48 weeks ]
Assess the safety and tolerability of ANAVEX2-73 compared to placebo

CDR-SB (Clinical Dementia Rating Scale Sum of Boxes) [ Time Frame: 48 weeks ]
Change from baseline to week 48 on Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) compared to placebo

RSCAQ sleep score [ Time Frame: Weeks 0, 4, 12, 24, 36, and 48 ]
To evaluate whether ANAVEX2-73 improves sleep continuity as assessed on a serial basis (weeks 0, 4, 12, 24, 36, and 48) with a questionnaire that assess reported sleep continuity (RSCAQ)


Other Outcome Measures:
Number of participants with change of brain volume assessed by MRI [ Time Frame: 48 weeks ]
Structural (and optional ASL) MRI scan assessments characteristic for AD pathophysiology from baseline and compared to placebo at +48 weeks

Blood assessment [ Time Frame: 48 weeks ]
Blood assessment from baseline and compared to placebo at +48 weeks: Abeta40, Abeta42, T-tau, NFL, YKL-40, BACE1 concentration

CSF assessment [ Time Frame: 48 weeks ]
Changes in CSF parameters (Abeta40, Abeta42, T-tau, P-tau, NFL, YKL-40, neurogranin, BACE1 concentration) characteristic for AD pathophysiology from baseline and compared to placebo at

+48 weekstreatment differences within subgroups will be performed


Number of participants with pre-specified genetic variants [ Time Frame: 48 weeks ]
AD relevant pre-specified genetic variants will be assessed. Statistical testing of treatment differences within subgroups will be performed



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