A Study of the Safety and Efficacy of Memantine in Moderate to Severe Alzheimer's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00322153
Recruitment Status : Completed
First Posted : May 5, 2006
Results First Posted : September 16, 2010
Last Update Posted : September 16, 2010
Information provided by:
Forest Laboratories

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Dementia of the Alzheimer's Type
Interventions: Drug: memantine ER
Drug: Placebo

  Participant Flow

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
Placebo Matching placebo oral administration once daily for 24 weeks.
Memantine ER 28mg once daily oral administration for 24 weeks.
Total Total of all reporting groups

Baseline Measures
   Placebo   Memantine ER   Total 
Overall Participants Analyzed 
[Units: Participants]
 335   341   676 
Age, Customized 
[Units: Participants]
<= 64 years   26   34   60 
65-74 years   79   85   164 
75-84 years   179   176   355 
>= 85 years   51   46   97 
[Units: Years]
Mean (Standard Deviation)
 76.8  (7.76)   76.2  (8.35)   76.5  (8.07) 
[Units: Participants]
Female   243   244   487 
Male   92   97   189 
Region of Enrollment 
[Units: Participants]
United States   85   93   178 
Argentina   158   153   311 
Chile   44   46   90 
Mexico   48   49   97 

  Outcome Measures

1.  Primary:   Change From Baseline in Severe Impairment Battery (SIB) at Week 24 (LOCF)   [ Time Frame: Baseline to week 24 ]

2.  Primary:   Clinician’s Interview-Based Impression of Change With Caregiver Input (CIBIC-plus) at Week 24 (LOCF)   [ Time Frame: Week 24 ]

3.  Secondary:   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 ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information