A Study of the Safety and Efficacy of Memantine in Moderate to Severe Alzheimer's Disease
|ClinicalTrials.gov Identifier: NCT00322153|
Recruitment Status : Completed
First Posted : May 5, 2006
Results First Posted : September 16, 2010
Last Update Posted : September 16, 2010
|Condition or disease||Intervention/treatment||Phase|
|Dementia of the Alzheimer's Type||Drug: memantine ER Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||677 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety and Efficacy of Memantine in Patients With Moderate-to-Severe Dementia of the Alzheimer's Type|
|Study Start Date :||June 2005|
|Actual Primary Completion Date :||October 2007|
|Actual Study Completion Date :||January 2008|
Placebo Comparator: Placebo
Oral administration, once daily.
Matching placebo oral administration once daily.
Active Comparator: Memantine ER
28mg, once daily. Oral administration for 24 weeks.
Drug: memantine ER
28mg(7mg capsules) once daily and oral administration for 24 weeks.
Other Name: Namenda XR
- Change From Baseline in Severe Impairment Battery (SIB) at Week 24 (LOCF) [ Time Frame: Baseline to week 24 ]The SIB was developed for the evaluation of cognitive function in patients with more advanced dementia, and evaluates the areas of memory, language, praxis, orientation, and attention. The SIB test items consist of simple, one-step commands presented with gestural cues that are repeated if necessary. The test contains 51 items, and the range of possible scores is 0 to 100 (with 0 being the worst result). The SIB has been shown to be a valid and reliable instrument sensitive to longitudinal change.
- Clinician's Interview-Based Impression of Change With Caregiver Input (CIBIC-plus) at Week 24 (LOCF) [ Time Frame: Week 24 ]The CIBIC-Plus is a measure of an overall clinical effect and is based on a comprehensive evaluation at Baseline and later visits of four domains: general (overall clinical status), functional (including activities of daily living), cognitive, and behavioral. A skilled clinician interviews the patient, and includes information supplied by a knowledgeable caregiver. The CIBIC-Plus is a rating of the patient's global status relative to Baseline, ranging from a score of 1, indicating "marked improvement" to a score of 4, indicating "no change" to a score of 7, indicating "marked worsening."
- Change From Baseline in the 19-Item Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL19) Scale at Week 24 (LOCF) [ Time Frame: Baseline to week 24 ]The ADCS-ADL19 modified inventory consists of 19 items used to measure the functional capabilities of patients with moderate to severe dementia. Each activity-of-daily-living (ADL) item comprises a series of hierarchical subquestions ranging from the highest level of independent performance to complete loss of ability to perform the ADL Inventory. The inventory is performed by interviewing a person in close contact with the patient and covers the most usual and consistent performance of the patient over the preceding 4 weeks. Response range is 0 (total disability) to 54 (total independence).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00322153
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|Study Director:||Stephen M Graham, PhD||Forest Laboratories|