An Evaluation of the Safety and Efficacy of Memantine in Agitated Patients With Moderate to Severe Alzheimer's Disease
A Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety and Efficacy of Memantine in Non-Institutionalized Agitated Patients With Moderate to Severe Alzheimer's Disease
1 other identifier
interventional
34
1 country
9
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 associated with Alzheimer's Disease. In a recent trial, in the group of patients with moderate to severe AD treated with memantine, there were fewer incidences of agitation. It is hypothesized that memantine will be effective in reducing the symptoms of agitation associated with moderate to severe Alzheimer's Disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Sep 2004
9 active sites
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
September 1, 2004
CompletedFirst Submitted
Initial submission to the registry
December 1, 2004
CompletedFirst Posted
Study publicly available on registry
December 2, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2006
CompletedMarch 5, 2012
March 1, 2012
1.6 years
December 1, 2004
March 1, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Neuropsychiatric Inventory
Secondary Outcomes (4)
Cohen Mansfield Agitation Inventory
Clinical Global Impression Scale
ADCS-ADL
Agitation/aggression domain of Neuropsychiatric Inventory (NPI)
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Other evidence of psychiatric disorders
- Oncologic diagnosis
- Clinically significant gastrointestinal, renal, hepatic, endocrine or cardiovascular disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
The Forves Norris MDA/ALS Research Center
San Francisco, California, 94115, United States
Coastal Communities Hospital
Westminster, California, 92683, United States
Alzheimer's Disease Research Unit
New Haven, Connecticut, 06510, United States
Berma Research Group
Hialeah, Florida, 33016, United States
Baumel-Eisner Neuromedical Institute
Miami, Florida, 33154, United States
Premiere Research Institute
West Palm Beach, Florida, 33407, United States
Geriatric Medicine
Honolulu, Hawaii, 96817, United States
The Memory Clinic
Bennington, Vermont, 05201, United States
Hampton Roads Center for Clinical Research
Norfolk, Virginia, 23502, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
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
December 1, 2004
First Posted
December 2, 2004
Study Start
September 1, 2004
Primary Completion
April 1, 2006
Study Completion
April 1, 2006
Last Updated
March 5, 2012
Record last verified: 2012-03