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

December 1, 2004
March 1, 2012
September 2004
April 2006   (final data collection date for primary outcome measure)
Neuropsychiatric Inventory
Same as current
Complete list of historical versions of study NCT00097916 on ClinicalTrials.gov Archive Site
  • Cohen Mansfield Agitation Inventory
  • Clinical Global Impression Scale
  • ADCS-ADL
  • Agitation/aggression domain of Neuropsychiatric Inventory (NPI)
Same as current
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Alzheimer's Disease
Drug: memantine HCl
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
34
April 2006
April 2006   (final data collection date for primary outcome measure)

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
Both
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00097916
MEM-MD-23
Not Provided
Not Provided
Forest Laboratories
Not Provided
Not Provided
Forest Laboratories
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP