Recent Updates
Recently added Catalysts

High dose ANAVEX2-73

Phase 2

Alzheimer Disease | Small molecule | Neurology |Anavex Life Sciences Corp.|Last Updated: Aug 12, 2024

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials2
Total Enrollment809

FDA Designations

FAST_TRACKORPHAN_DRUGRARE_PEDIATRIC_DISEASE

Clinical trial landscape

High dose ANAVEX2-73 · 3 trials · 2 indications

Phase 2 3
NCT04314934OLE of Phase 2b/3 Study ANAVEX2-73-AD-004Alzheimer Disease
COMPLETED300 Analytics
NCT03774459ANAVEX2-73 Study in Parkinson's Disease DementiaParkinsons Disease With Dementia
COMPLETED132 Analytics
NCT03790709ANAVEX2-73 for Treatment of Early Alzheimer's DiseaseAlzheimer Disease
COMPLETED509 Analytics
PHASE2COMPLETED
OLE of Phase 2b/3 Study ANAVEX2-73-AD-004
Alzheimer DiseaseUnlock trial analytics
PHASE2COMPLETED
ANAVEX2-73 Study in Parkinson's Disease Dementia
Parkinsons Disease With DementiaUnlock trial analytics
PHASE2COMPLETED
ANAVEX2-73 for Treatment of Early Alzheimer's Disease
Alzheimer DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of participants with treatment-related adverse events as assessed by CTCAE v4.03
96 weeks

To continue assessing the safety and tolerability of ANAVEX2-73

Cognitive Drug Research (CDR) Computerized Assessment System Continuity of Attention
14 weeks

Change from Baseline to End of Treatment in Continuity of Attention as measured by Cognitive Drug Research (CDR) Computerized Assessment System Continuity of Attention test

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
14 weeks

Assess the safety and tolerability of ANAVEX2-73 compared to placebo

ADAS-Cog (Alzheimer Disease Assessment Scale-Cognition)
48 weeks

Reduction in cognitive decline assessed from baseline over 48 weeks with ANAVEX2-73 compared to placebo using the Alzheimer Disease Assessment Scale-Cognition (ADAS-Cog)

ADCS-ADL (Activities of Daily Living)
48 weeks

Reduction in decline of the ability to perform daily activities assessed from baseline over 48 weeks with ANAVEX2-73 compared to placebo using the Activities of Daily Living Scale (ADCS-ADL)

Secondary Endpoints

ADAS-Cog (Alzheimer Disease Assessment Scale-Cognition)
96 weeks
ADCS-ADL (Activities of Daily Living)
96 weeks
MDS-UPDRS Part III Total Score (Motor Scores)
14 weeks
Unlock Study Endpoints

Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
ActiveEXPERIMENTALANAVEX2-73
High dose ANAVEX2-73EXPERIMENTALHigh dose ANAVEX2-73
Mid dose ANAVEX2-73EXPERIMENTALMid dose ANAVEX2-73
Placebo oral capsulePLACEBO_COMPARATORPlacebo oral capsule

Interventions

NameTypeDescription
ANAVEX2-73DRUGOral capsules
High dose ANAVEX2-73DRUGActive oral capsule
Mid dose ANAVEX2-73DRUGActive oral capsule
Placebo oral capsuleDRUGPlacebo oral capsule
Unlock Study Design Details

Eligibility Criteria

Age Range55 Years to 85 Years
SexALL
Healthy VolunteersNo
Study Sites51

Inclusion Criteria: * Previous completion of participation in the ANAVEX2-73-AD-004 double-blind study. * Participants may be either outpatients, or residents of an assisted-living facility. * Participants must have a designated study partner, who spends at least 10hrs per week with the participant...

Countries:AustraliaCanadaGermanyNetherlandsUnited KingdomSpain
Unlock Eligibility Criteria

Frequently asked questions about High dose ANAVEX2-73

What is ANAVEX2-73 used for?

ANAVEX2-73 is an investigational small molecule being developed for neurological conditions including Rett Syndrome, Parkinson's Disease With Dementia, and Alzheimer's Disease. It is in Phase 2 clinical development and has not been approved by the FDA.

Who makes ANAVEX2-73?

ANAVEX2-73 is being developed by Anavex Life Sciences Corp., a biopharmaceutical company traded on NASDAQ under the ticker AVXL. The company is conducting clinical trials for this drug in multiple countries.

What phase is ANAVEX2-73 in?

ANAVEX2-73 is in Phase 2 clinical development. It has completed two Phase 2 trials and two open-label extension studies, with a total enrollment of 809 participants across all studies. The drug is investigational and not yet FDA approved.

What clinical trials is ANAVEX2-73 in?

ANAVEX2-73 has completed several clinical trials, including NCT03774459 for Parkinson's Disease Dementia, NCT03790709 for early Alzheimer's Disease, and open-label extensions NCT04314934 and NCT04575259. All trials were Phase 2 and are now completed.

Does ANAVEX2-73 have FDA designations?

Yes, ANAVEX2-73 has received Fast Track designation, Orphan Drug designation, and Rare Pediatric Disease designation from the FDA. These designations are intended to expedite development and review of the drug for serious conditions.

Is ANAVEX2-73 the same as blarcamesine?

ANAVEX2-73 is also known as blarcamesine, though this alternative name is not provided in the available data. The drug is being studied under the name ANAVEX2-73 in clinical trials for Alzheimer's disease and Parkinson's disease dementia.