Efficacy and Safety of Memantine Hydrochloride in Enhancing the Cognitive Abilities of Young Adults With Down Syndrome

This study has been completed.
Sponsor:
Collaborator:
Forest Laboratories
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT01112683
First received: April 23, 2010
Last updated: December 26, 2012
Last verified: December 2012
Results First Received: July 25, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Down Syndrome
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
A total of 42 persons with DS from both genders and between the ages of 18 and 32 were recruited from the community. Thirty nine participants had a cytogenetic diagnostic of trisomy 21 and 3 had complete unbalanced Robertsonian translocations involving a 14 and 21 homologue, leading to an additional chromosome 21.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Two screened subjects were excluded from the trial before assignment to groups: 1 due to an unrelated medical issue and 1 because we could not find age/gender matching subject. And 1 dropped from the trial after randomization due to personal reasons (death in the family).

Reporting Groups
  Description
Memantine The drug dosage will follow memantine's standard titration schedule (i.e., 5 mg/d week one, 5 mg/BID week two, 5 & 10 mg/d divided dose week three, 10mg/BID week four).
Placebo These are identically-looking pills to the ones in the Memantine Arm

Participant Flow:   Overall Study
    Memantine     Placebo  
STARTED     19     20  
COMPLETED     18     19  
NOT COMPLETED     1     1  



  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.
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Reporting Groups
  Description
Memantine The drug dosage will follow memantine's standard titration schedule (i.e., 5 mg/d week one, 5 mg/BID week two, 5 & 10 mg/d divided dose week three, 10mg/BID week four).
Placebo These are identically-looking pills to the ones in the Memantine Arm
Total Total of all reporting groups

Baseline Measures
    Memantine     Placebo     Total  
Number of Participants  
[units: participants]
  19     20     39  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     19     20     39  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  23.27  ± 3.52     22.60  ± 4.01     22.93  ± 3.76  
Gender  
[units: participants]
     
Female     12     13     25  
Male     7     7     14  
Region of Enrollment  
[units: participants]
     
United States     19     20     39  



  Outcome Measures
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1.  Primary:   Changes in Neuropsychological Measures From Baseline to End of Study   [ Time Frame: These neuropsychological measures will be assessed one time 24 hours before the beginning of treatment and then a second time 16 weeks from the beginning of the treatment ]

2.  Secondary:   Changes in Benchmark Neuropsychological Measures From Baseline to End of Study   [ Time Frame: Benchmark neuropsychological measures will be assessed one time 24 hours before the beginning of treatment and then a second time 16 weeks from the beginning of the treatment ]

3.  Secondary:   Changes of Safety and Tolerability Assessments at Baseline and End of Study   [ Time Frame: Safety and tolerability assessments will be performed at three time points: 1) 1-7 days before beginning of treatment; 2) after 8 weeks from the beginning of the treatment; and 3) 16-17 weeks from the beginning of the 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: Dr. Alberto Costa
Organization: University of Colorado School of Medicine
phone: 303-724-6007
e-mail: Alberto.Costa@ucdenver.edu


Publications of Results:

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01112683     History of Changes
Other Study ID Numbers: 06-0934, 06-0934
Study First Received: April 23, 2010
Results First Received: July 25, 2012
Last Updated: December 26, 2012
Health Authority: United States: Food and Drug Administration