Status:
COMPLETED
An Evaluation of the Safety and Efficacy of Memantine in Agitated Patients With Moderate to Severe Alzheimer's Disease
Lead Sponsor:
Forest Laboratories
Conditions:
Alzheimer's Disease
Eligibility:
All Genders
50+ years
Phase:
PHASE3
Brief Summary
About 65% of patients with severe Alzheimer's Disease (AD) will have symptoms of agitation. There are drawbacks associated with the currently available therapeutic interventions for agitation associat...
Eligibility Criteria
Inclusion
- Moderate to Severe Alzheimer's Disease with a score greater than or equal to 4 on agitation/aggression domain of NPI
- Stable dose of donepezil for 3 months
Exclusion
- Other evidence of psychiatric disorders
- Oncologic diagnosis
- Clinically significant gastrointestinal, renal, hepatic, endocrine or cardiovascular disease
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2006
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT00097916
Start Date
September 1 2004
End Date
April 1 2006
Last Update
March 5 2012
Active Locations (9)
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1
The Forves Norris MDA/ALS Research Center
San Francisco, California, United States, 94115
2
Coastal Communities Hospital
Westminster, California, United States, 92683
3
Alzheimer's Disease Research Unit
New Haven, Connecticut, United States, 06510
4
Berma Research Group
Hialeah, Florida, United States, 33016