Study Phase 2

A group comparative, placebo-controlled, double-blind trial of the efficacy and safety of galantamine hydrobromide, 7.5 mg (6 mg galantamine base) TID, 10 mg (8 mg galantamine base) TID and 15 mg (12 mg galantamine base) TID taken orally for 12 weeks in patients with a diagnosis of senile dementia of the Alzheimer's type

Trial Information

Generic NameGalantamine hydrobromideProduct NameRAZADYNE®Therapeutic AreaNervous SystemProduct ClassPsychoanalepticsPharmacological SubgroupAnti-Dementia DrugsChemical SubgroupAnticholinesterasesCondition StudiedAlzheimer Disease
Sponsor Protocol NumberGAL-93-01Enrollment285Data PartnerJohnson & Johnson% FemaleN/AMean/Median Age (Years)N/A% WhiteN/A

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

Disclaimer

Clinical study data provided through this site do not replace the official labeling of a given drug product, which presents benefits and risks of the product for approved use(s). Before prescribing any product, health care professionals should consult the current prescribing information approved in their country. Patients seeking information may consult with their health care professional about the product, for which health authority approved written patient information may be available.