Status:
COMPLETED
A Randomized, Double-blind, Flexible Dose, Multicenter Study to Evaluate the Effectiveness and Safety of Galantamine IR in Mild to Moderate Alzheimer's Disease
Lead Sponsor:
Xian-Janssen Pharmaceutical Ltd.
Conditions:
Alzheimer Disease
Eligibility:
All Genders
40+ years
Phase:
PHASE3
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 ...
Detailed Description
This is a randomized, double-blind, active-controlled, flexible dosage, multicenter study to evaluate the effectiveness and safety of galantamine tablet in the treatment of mild to moderate AD. The co...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2005
Estimated Enrollment :
215 Patients enrolled
Trial Details
Trial ID
NCT00645190
Start Date
March 1 2004
End Date
February 1 2005
Last Update
May 19 2011
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