A Randomized, Double-blind, Flexible Dose, Multicenter Study to Evaluate the Effectiveness and Safety of Galantamine IR in Mild to Moderate Alzheimer's Disease
A Randomized, Double Blind, Active Control, Flexible Dose, Multicenter Study to Evaluate Galantamine HBr in the Treatment of Alzheimer's Disease:Safety and Effectiveness of an Immediate-release Table Formulation.
1 other identifier
interventional
215
0 countries
N/A
Brief Summary
The purpose of this randomized, double-blind, active-controlled, flexible dosage, multicenter study is to evaluate the effectiveness and safety of galantamine tablet (16-24mg/day) for 16 weeks in the treatment of mild to moderate Alzheimer's Disease (AD) comparing with Donepezil.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 alzheimer-disease
Started Mar 2004
Shorter than P25 for phase_3 alzheimer-disease
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2005
CompletedFirst Submitted
Initial submission to the registry
March 24, 2008
CompletedFirst Posted
Study publicly available on registry
March 27, 2008
CompletedMay 19, 2011
March 1, 2010
March 24, 2008
May 18, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Primary endpoint (ADAS-cog/11) decreased 5.4 ± 6.4 and 4 .0 ± 7.3 in galantamine and Donepezil group respectively after 16-week treatment from baseline of 22.5 ± 9.3 and 23.3 ± 9.7 respectively, showing the non-inferiority in term of efficacy.
Secondary Outcomes (1)
Secondary endpoint is responder rate. It showed 78% responder rate in galantamine group and 58% responder rate in Donepezil group after 16 weeks.
Interventions
Eligibility Criteria
You may qualify if:
- Out-patients diagnosed with mild to moderate probable AD. The diagnosis should have been established in accordance with the classification for probable AD of NINCDS-ADRDA
- MMSE score of 10-24 (inclusive) at screening
- Patients who lived with or had regular daily visits from a responsible caregiver
- Has signed the informed consent form by subject and assent form by care-giver
You may not qualify if:
- Patients with neurodegenerative disorders such as Parkinson's disease
- Patients with some conditions possibly resulting in cognitive impairment, e.g. acute cerebral trauma, infection
- Has evidence of multi-infarct dementia or clinically active cerebrovascular disease.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Xian-Janssen Pharmaceutical Ltd. Clinical Trial
Xian-Janssen Pharmaceutical Ltd.
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 24, 2008
First Posted
March 27, 2008
Study Start
March 1, 2004
Study Completion
February 1, 2005
Last Updated
May 19, 2011
Record last verified: 2010-03