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

Forest Laboratories9 sites in 1 country34 target enrollmentSeptember 2004

ConditionsAlzheimer's Disease

Drugsmemantine HCl

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Alzheimer's Disease
Sponsor: Forest Laboratories
Enrollment: 34
Locations: 9
Primary Endpoint: Neuropsychiatric Inventory
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 2004

End Date

April 2006

Last Updated

14 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Forest Laboratories

Eligibility Criteria

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