An Evaluation of the Safety and Efficacy of Memantine in Agitated Patients With Moderate to Severe Alzheimer's Disease

Alzheimer's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00097916
• Other study ID #: MEM-MD-23
• Status: Completed
• Phase: Phase 3
• First received: December 1, 2004
• Last updated: March 1, 2012
• Start date: September 2004
• Est. completion date: April 2006

Study information

• Verified date: March 2012
• Source: Forest Laboratories
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: April 2006
• Est. primary completion date: April 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• 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 Criteria:

• Other evidence of psychiatric disorders

• Oncologic diagnosis

• Clinically significant gastrointestinal, renal, hepatic, endocrine or cardiovascular disease

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• memantine HCl

Locations

Country	Name	City	State
United States	The Memory Clinic	Bennington	Vermont
United States	Berma Research Group	Hialeah	Florida
United States	Geriatric Medicine	Honolulu	Hawaii
United States	Baumel-Eisner Neuromedical Institute	Miami	Florida
United States	Alzheimer's Disease Research Unit	New Haven	Connecticut
United States	Hampton Roads Center for Clinical Research	Norfolk	Virginia
United States	The Forves Norris MDA/ALS Research Center	San Francisco	California
United States	Premiere Research Institute	West Palm Beach	Florida
United States	Coastal Communities Hospital	Westminster	California

Sponsors (1)

Lead Sponsor	Collaborator
Forest Laboratories

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neuropsychiatric Inventory
Secondary	Cohen Mansfield Agitation Inventory
Secondary	Clinical Global Impression Scale
Secondary	ADCS-ADL
Secondary	Agitation/aggression domain of Neuropsychiatric Inventory (NPI)