Effects of Memantine on Magnetic Resonance (MR) Spectroscopy in Subjects at Risk for 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: NCT00933608
Recruitment Status : Completed
First Posted : July 7, 2009
Results First Posted : October 21, 2014
Last Update Posted : October 21, 2014
Forest Laboratories
Information provided by (Responsible Party):
Lidia Glodzik, New York University School of Medicine

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Basic Science
Condition: Alzheimer's Disease
Interventions: Drug: memantine
Drug: Placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment for this study was carried out at the NYU Center for Brain Health and Aging and Dementia Center, between May 2010 and October 2011.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
Memantine memantine : participants will be asked to take memantine (20mg/day) for 16 weeks
Placebo participants were taking 1 tablet twice a day to match memantine arm

Participant Flow:   Overall Study
    Memantine   Placebo
STARTED   7   10 
COMPLETED   2   8 
Adverse Event                4                2 
Physician Decision                1                0 

  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
Memantine memantine : participants will be asked to take memantine (20mg/day) for 16 weeks
Placebo No text entered.
Total Total of all reporting groups

Baseline Measures
   Memantine   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 7   10   17 
[Units: Participants]
<=18 years   0   0   0 
Between 18 and 65 years   1   4   5 
>=65 years   6   6   12 
[Units: Years]
Mean (Standard Deviation)
 69.7  (5.7)   69.7  (8.2)   69.7  (7.1) 
[Units: Participants]
Female   6   5   11 
Male   1   5   6 
Region of Enrollment 
[Units: Participants]
United States   7   10   17 

  Outcome Measures

1.  Primary:   N-acetylaspartate   [ Time Frame: baseline (pre-treatment) and 4 months (post-treatment) ]

  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

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact:  
Name/Title: Lidia Glodzik
Organization: NYU School of Medicine
phone: 212.263.5698

Responsible Party: Lidia Glodzik, New York University School of Medicine Identifier: NCT00933608     History of Changes
Other Study ID Numbers: NAM-MD-68
First Submitted: July 2, 2009
First Posted: July 7, 2009
Results First Submitted: May 8, 2013
Results First Posted: October 21, 2014
Last Update Posted: October 21, 2014