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Effect of Memantine on Functional Communication in Patients With Alzheimer's Disease

This study has been completed.
Sponsor:
Information provided by:
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT00469456
First received: May 2, 2007
Last updated: December 21, 2009
Last verified: December 2009
History of Changes
Results First Received: November 3, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
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
The recruitment period was from May 24, 2007 to July 29, 2008 at 25 centers in three countries [14 in Australia, 3 in New Zealand, 8 in South Africa].

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Study consisted of up to 2 weeks single-blind placebo treatment followed by 12 weeks double-blind treatment. At end of single-blind placebo treatment, patients (pts) meeting entry criteria were randomized (1:1) to 1 of 2 double-blind treatment groups receiving memantine or placebo. Pts not meeting inclusion/exclusion criteria were not randomized.

Reporting Groups
  Description
Placebo Matching placebo, oral administration, twice daily for 12 weeks
Memantine Memantine 20mg (10mg twice daily), oral administration for 12 weeks

Participant Flow:   Overall Study
    Placebo     Memantine  
STARTED     129 [1]   135 [2]
COMPLETED     120     131  
NOT COMPLETED     9     4  
Adverse Event                 4                 3  
Protocol Violation                 1                 0  
Withdrawal by Subject                 4                 1  
[1] Safety Population defined as all patients who took at least one dose of double-blind study drug
[2] Safety Population defined as all patients who took at least one dose of double-blind study drug.



  Baseline Characteristics
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Reporting Groups
  Description
Placebo Matching placebo, oral administration, twice daily for 12 weeks
Memantine Memantine 20mg (10mg twice daily), oral administration for 12 weeks
Total Total of all reporting groups

Baseline Measures
    Placebo     Memantine     Total  
Number of Participants  
[units: participants]
 		  129     135     264  
Age, Customized  
[units: participants]
 		     
<=64 years     19     13     32  
65-74 years     33     51     84  
75-84 years     59     56     115  
>=85 years     18     15     33  
Age  
[units: years]
Mean ± Standard Deviation 		  75.1  ± 8.68     74.8  ± 8.05     74.9  ± 8.35  
Gender [1]
[units: participants]
 		     
Female     74     80     154  
Male     55     55     110  
Region of Enrollment  
[units: participants]
 		     
Australia     55     55     110  
South Africa     58     62     120  
New Zealand     16     18     34  
[1] One patient was randomized but did not receive study drug.



  Outcome Measures
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1.  Primary:   Change From Baseline in Functional Linguistic Communication Inventory (FLCI) at Week 12   [ Time Frame: Baseline to Week 12 ]
  Show Outcome Measure 1

2.  Secondary:   Change From Baseline in American Speech-Language-Hearing Association Functional Assessment of Communication Skills for Adults (ASHA FACS) [Total Score of Social Communication and Communication of Basic Needs Subscores] at Week 12   [ Time Frame: Baseline to Week 12 ]
  Show Outcome Measure 2


  Serious Adverse Events
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  Other Adverse Events
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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 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


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
No text entered.  


Results Point of Contact:  
Name/Title: Stephen Graham, PhD
Organization: Forest Research Institute, a subsidiary of Forest Laboratories Inc.
phone: 201-427-8156
e-mail: stephen.graham@frx.com


No publications provided


Responsible Party: Stephen Graham, PhD, Sr. Director, Forest Research Institute, a division of Forest Laboratories, Inc.
ClinicalTrials.gov Identifier: NCT00469456     History of Changes
Other Study ID Numbers: MEM-MD-71
Study First Received: May 2, 2007
Results First Received: November 3, 2009
Last Updated: December 21, 2009
Health Authority: Australia: Human Research Ethics Committee
Australia: Department of Health and Ageing Therapeutic Goods Administration
South Africa: National Health Research Ethics Council
South Africa: Medicines Control Council
New Zealand: Health Research Council
New Zealand: Medsafe