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

This study has been completed.
Sponsor:
Information provided by:
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT00097916
First received: December 1, 2004
Last updated: March 1, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention Phase
Alzheimer's Disease
Drug: memantine HCl
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Forest Laboratories:

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)

Enrollment: 34
Study Start Date: September 2004
Study Completion Date: April 2006
Primary Completion Date: April 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00097916

Locations
United States, California
The Forves Norris MDA/ALS Research Center
San Francisco, California, United States, 94115
Coastal Communities Hospital
Westminster, California, United States, 92683
United States, Connecticut
Alzheimer's Disease Research Unit
New Haven, Connecticut, United States, 06510
United States, Florida
Berma Research Group
Hialeah, Florida, United States, 33016
Baumel-Eisner Neuromedical Institute
Miami, Florida, United States, 33154
Premiere Research Institute
West Palm Beach, Florida, United States, 33407
United States, Hawaii
Geriatric Medicine
Honolulu, Hawaii, United States, 96817
United States, Vermont
The Memory Clinic
Bennington, Vermont, United States, 05201
United States, Virginia
Hampton Roads Center for Clinical Research
Norfolk, Virginia, United States, 23502
Sponsors and Collaborators
Forest Laboratories
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00097916     History of Changes
Other Study ID Numbers: MEM-MD-23
Study First Received: December 1, 2004
Last Updated: March 1, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Forest Laboratories:
memantine HCl
Dementia
Agitation
Alzheimer Disease

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Memantine
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 26, 2014