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

Primary Purpose

Alzheimer's Disease

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
memantine HCl
Sponsored by
Forest Laboratories
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer's Disease focused on measuring memantine HCl, Dementia, Agitation, Alzheimer Disease

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Forves Norris MDA/ALS Research Center
  • Coastal Communities Hospital
  • Alzheimer's Disease Research Unit
  • Berma Research Group
  • Baumel-Eisner Neuromedical Institute
  • Premiere Research Institute
  • Geriatric Medicine
  • The Memory Clinic
  • Hampton Roads Center for Clinical Research

Outcomes

Primary Outcome Measures

Neuropsychiatric Inventory

Secondary Outcome Measures

Cohen Mansfield Agitation Inventory
Clinical Global Impression Scale
ADCS-ADL
Agitation/aggression domain of Neuropsychiatric Inventory (NPI)

Full Information

First Posted
December 1, 2004
Last Updated
March 1, 2012
Sponsor
Forest Laboratories
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1. Study Identification

Unique Protocol Identification Number
NCT00097916
Brief Title
An Evaluation of the Safety and Efficacy of Memantine in Agitated Patients With Moderate to Severe Alzheimer's Disease
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
September 2004 (undefined)
Primary Completion Date
April 2006 (Actual)
Study Completion Date
April 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Forest Laboratories

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
Keywords
memantine HCl, Dementia, Agitation, Alzheimer Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
memantine HCl
Primary Outcome Measure Information:
Title
Neuropsychiatric Inventory
Secondary Outcome Measure Information:
Title
Cohen Mansfield Agitation Inventory
Title
Clinical Global Impression Scale
Title
ADCS-ADL
Title
Agitation/aggression domain of Neuropsychiatric Inventory (NPI)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
The Forves Norris MDA/ALS Research Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Coastal Communities Hospital
City
Westminster
State/Province
California
ZIP/Postal Code
92683
Country
United States
Facility Name
Alzheimer's Disease Research Unit
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Berma Research Group
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
Baumel-Eisner Neuromedical Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33154
Country
United States
Facility Name
Premiere Research Institute
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
Facility Name
Geriatric Medicine
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96817
Country
United States
Facility Name
The Memory Clinic
City
Bennington
State/Province
Vermont
ZIP/Postal Code
05201
Country
United States
Facility Name
Hampton Roads Center for Clinical Research
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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