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

This study has been completed.
Sponsor:
Information provided by:
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT00322153
First received: May 3, 2006
Last updated: August 25, 2010
Last verified: August 2010
Results First Received: July 20, 2010  
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: Dementia of the Alzheimer's Type
Interventions: Drug: memantine ER
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 20, 2005 to April 18th, 2007 at 83 study centers in four countries (23 in Argentina, 11 in Chile, 11 in Mexico, and 38 in the US)

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Study consisted of 1-2 weeks single-blind placebo treatment followed by 24 weeks double-blind treatment. At the end of single-blind placebo treatment, patients meeting entry criteria were randomized (1:1) to 1 of 2 double-blind treatment groups receiving memantine or placebo.

Reporting Groups
  Description
Placebo Matching placebo oral administration once daily for 24 weeks.
Memantine ER 28mg once daily oral administration for 24 weeks.

Participant Flow:   Overall Study
    Placebo     Memantine ER  
STARTED     335 [1]   342 [2]
SAFETY POPULATION     335 [3]   341 [4]
COMPLETED     272     273  
NOT COMPLETED     63     69  
Adverse Event                 21                 34  
Protocol Violation                 6                 14  
Withdrawal by Subject                 18                 10  
Lack of Efficacy                 8                 3  
Lost to Follow-up                 5                 4  
Withdrawn for other reasons                 5                 4  
[1] Randomized to placebo
[2] Randomized to Memantine ER
[3] Safety population defined as all patients who took at least one dose of double-blind study drug.
[4] Safety population: one patient was randomized but did not receive double-blind study drug.



  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
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  
Number of Participants  
[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  
Age  
[units: years]
Mean ± Standard Deviation
  76.8  ± 7.76     76.2  ± 8.35     76.5  ± 8.07  
Gender  
[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
  Show All 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
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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
No text entered.


  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.


Results Point of Contact:  
Name/Title: Stephen M Graham, PhD
Organization: Forest Research Institute
phone: 201-427-8156
e-mail: Stephen.Graham@frx.com


No publications provided


Responsible Party: Stephen M Graham, PhD, Senior Director, Clinical Development, Neurology, Forest Research Institute, a subsidiary of Forest Laboratories, Inc
ClinicalTrials.gov Identifier: NCT00322153     History of Changes
Other Study ID Numbers: MEM-MD-50
Study First Received: May 3, 2006
Results First Received: July 20, 2010
Last Updated: August 25, 2010
Health Authority: United States: Food and Drug Administration
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Argentina: Human Research Bioethics Committee
Argentina: Ministry of Health
Chile: Instituto de Salud Pública de Chile
Mexico: Ethics Committee
Mexico: Ministry of Health
Mexico: Secretaria de Salud