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Trial Information
Generic NameGalantamineProduct NameRAZADYNE®Therapeutic AreaNervous SystemProduct ClassPsychoanalepticsPharmacological SubgroupAnti-Dementia DrugsChemical SubgroupAnticholinesterasesCondition StudiedAlzheimer Disease
Sponsor Protocol NumberGAL-USA-1Enrollment636Data PartnerJohnson & Johnson% Female62%Mean/Median Age (Years)75.7% White91%
Supporting Documentation
- Collected Datasets Available
- Data Definition Specification Available
- Protocol with Amendments Available
- Statistical Analysis Plan Available
- Clinical Study Report Available
Approved Data Requests Associated with this Trial
- 2024-0984 : Investigating the Efficacy and Safety of Bapineuzumab and Galantamine in Treating Alzheimer’s Disease
- 2022-5053 : Adverse events reported in association with APOE genotype during clinical trials
- 2021-4836 : Adverse events of acetylcholinesterase inhibitors - systematic review and meta-analysis of double-blind randomized controlled trials
- 2016-0765 : Improving the statistical analysis of cognitive outcomes in randomised controlled trials: The ?Optimising the Analysis of Cognition? Collaboration
- 2015-0592 : Detection of uninformative clinics during the trial of a new drug using statistical and machine learning techniques