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	Treatment or Intervention	Phase
Alzheimer's Disease	Drug: memantine HCl	Phase III

Further Study Details: 

Primary Outcomes: Neuropsychiatric Inventory
Secondary Outcomes: Cohen Mansfield Agitation Inventory; Clinical Global Impression Scale; ADCS-ADL; Agitation/aggression domain of Neuropsychiatric Inventory (NPI)
Expected Total Enrollment:  150

Ages Eligible for Study:  50 Years and above,  Genders Eligible for Study:  Both

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

California
      Apex Research Institute, Santa Ana,  California,  92705,  United States; Recruiting
Connecticut
      Alzheimer's Disease Research Unit, New Haven,  Connecticut,  06510,  United States; Recruiting
Florida
      Berma Research Group, Hialeah,  Florida,  33016,  United States; Recruiting
      Palm Beach Neurology, West Palm Beach,  Florida,  33407,  United States; Recruiting
      Baumel-Eisner Neuromedical Center, Boca Raton,  Florida,  33486,  United States; Recruiting
      Premiere Research Institute, West Palm Beach,  Florida,  33407,  United States; Recruiting
      Baumel-Eisner Neuromedical Institute, Miami,  Florida,  33154,  United States; Recruiting
Hawaii
      Geriatric Medicine, Honolulu,  Hawaii,  96817,  United States; Recruiting
Kentucky
      The Lexington Clinic, Lexington,  Kentucky,  40504,  United States; Recruiting
Missouri
      St. Charles Psychiatric Associates, St. Charles,  Missouri,  63301,  United States; Recruiting
New Jersey
      Alzheimer's Research Corporation, Lakehurst,  New Jersey,  08733,  United States; Recruiting
      Meridian Institute for Aging, Manchester,  New Jersey,  08759,  United States; Recruiting
North Carolina
      Piedmont Medical Research, Winston Salem,  North Carolina,  27103,  United States; Recruiting
Texas
      UT Southwestern Medical Center at Dallas, Dallas,  Texas,  75390-9129,  United States; Recruiting
Vermont
      The Memory Clinic, Bennington,  Vermont,  05201,  United States; Recruiting
Virginia
      Hampton Roads Center for Clinical Research, Norfolk,  Virginia,  23502,  United States; Recruiting

Study ID Numbers:  MEM-MD-23
Record last reviewed:  March 2005
Last Updated:  March 21, 2005
Record first received:  December 1, 2004
ClinicalTrials.gov Identifier:  NCT00097916
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08