CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 580 enrolled
Drug / intervention
Placebo +2 moredrug
Likely dose
Galantamine 16 mg/dayfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00814801
NCT00814801Phase 3Completed
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Placebo-controlled Confirmatory Study of Galantamine (R113675) for Alzheimer's Type Dementia

Janssen Pharmaceutical K.K.·interventional·Posted Dec 25, 2008·Updated Apr 17, 2014

In Brief

A Phase 3 clinical trial evaluating Placebo, Galantamine 16 mg/day, and 1 other intervention for Alzheimer's Disease. Completed, enrolled 580 participants across 1 site.

Detailed Summary

The purpose of this study is to evaluate the efficacy and safety of two fixed doses (16mg/day and 24mg/day) of galantamine (a drug for treating dementia) versus placebo for the treatment of patients with Alzheimer's disease.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAlzheimer's Disease
CountriesJapan
Collaborators--

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 25, 2008
Enrollment StartFeb 1, 2007
Primary CompletionSep 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 17.5 years ago

Interventions

Placebodrug

Form= tablet, route= oral use. Corresponding placebo tablets confirmed to be indistinguishable from the galantamine tablets will be administered for 24 weeks.

Galantamine 16 mg/daydrug

Type= exact number, number= 8, 16, unit= mg/day, form= tablet, route= oral use. Patients will receive 8 mg galantamine daily for the first 4 weeks, and 16 mg galantamine daily for the remaining 20 weeks.

Galantamine 24 mg/daydrug

Type= exact number, number= 8, 16, 24, unit= mg/day, form= tablet, route= oral use. Patients will receive 8 mg galantamine daily for the first 4 weeks, then 16 mg galantamine daily for the following 4 weeks, and 24 mg galantamine daily for the remaining 16 weeks.