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Effects of Memantine on Magnetic Resonance (MR) Spectroscopy in Subjects at Risk for Alzheimer's Disease

This study has been completed.
Sponsor:
Collaborator:
Forest Laboratories
Information provided by (Responsible Party):
Lidia Glodzik, New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT00933608
First received: July 2, 2009
Last updated: October 20, 2014
Last verified: October 2014
Results First Received: May 8, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Basic Science
Condition: Alzheimer's Disease
Interventions: Drug: memantine
Drug: Placebo

  Participant Flow
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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
No text entered.

Reporting Groups
  Description
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  
NOT COMPLETED     5     2  
Adverse Event                 4                 2  
Physician Decision                 1                 0  



  Baseline Characteristics
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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.
No text entered.

Reporting Groups
  Description
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  
Number of Participants  
[units: participants]
  7     10     17  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     1     4     5  
>=65 years     6     6     12  
Age  
[units: years]
Mean ± Standard Deviation
  69.7  ± 5.7     69.7  ± 8.2     69.7  ± 7.1  
Gender  
[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
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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
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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
e-mail: Lidia.Glodzik@nyumc.org


No publications provided


Responsible Party: Lidia Glodzik, New York University School of Medicine
ClinicalTrials.gov Identifier: NCT00933608     History of Changes
Other Study ID Numbers: NAM-MD-68
Study First Received: July 2, 2009
Results First Received: May 8, 2013
Last Updated: October 20, 2014
Health Authority: United States: Institutional Review Board