Memantine and Antipsychotics Use (MemAP)

This study has been terminated.
(Study terminated due to too slow enrollment)
Sponsor:
Information provided by (Responsible Party):
Merz Pharmaceuticals GmbH
ClinicalTrials.gov Identifier:
NCT00649220
First received: March 27, 2008
Last updated: September 22, 2011
Last verified: September 2011
Results First Received: August 9, 2011  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Alzheimer's Disease
Intervention: Drug: Memantine

  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
No text entered.

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 tablets, twice a day (bid).

Participant Flow:   Overall Study
    Memantine  
STARTED     19  
COMPLETED     16  
NOT COMPLETED     3  
Adverse Event                 2  
Withdrawal by Subject                 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.
No text entered.

Reporting Groups
  Description
Memantine Memantine tablets, twice a day (bid).

Baseline Measures
    Memantine  
Number of Participants  
[units: participants]
  19  
Age  
[units: years]
Mean ± Standard Deviation
  72.4  ± 9.7  
Age, Customized  
[units: participants]
 
Between 50 and 85 years     19  
Gender  
[units: participants]
 
Female     10  
Male     9  
Region of Enrollment  
[units: participants]
 
Germany     19  



  Outcome Measures
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1.  Primary:   Maximum Dose Reduction of Antipsychotics (AP) in Percent of Defined Daily Dose (DDD) From Baseline to a Post-baseline Visit at Which the Value of the Visual Analogue Scale (VAS) Compared With the Baseline Value Was =< 15 Percent.   [ Time Frame: Week 8-20 post baseline ]

2.  Secondary:   Reduction of Antipsychotic Drug Dose From Baseline to Week 8, 12, 16 and/or 20.   [ Time Frame: Week 8-20 post Baseline ]

3.  Secondary:   Change in the Mini-Mental State Examination (MMSE) Score Value From Baseline to Week 20.   [ Time Frame: Week 20 post baseline ]

4.  Secondary:   Change of "Test for the Early Detection of Dementia With Discrimination From Depression [TE4D]" Score Value From Baseline to Week 4, 8, 12, 16, and/or 20 - First Part: Total Dementia   [ Time Frame: Week 4-20 post baseline ]

5.  Secondary:   Change of "Test for the Early Detection of Dementia With Discrimination From Depression [TE4D]" Score Value From Baseline to Week 4, 8, 12, 16, and/or 20 - Second Part: Total Depression   [ Time Frame: Week 4-20 post Baseline ]

6.  Secondary:   Change of Modified Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADLB19) Score Value From Baseline to Week 4, 8, 12, 16, and/or 20.   [ Time Frame: Week 4-20 post Baseline ]

7.  Secondary:   Change of Nurses’ Observation Scale for Geriatric Patients [NOSGER] Total Score Value From Baseline to Week 4, 8, 12, 16, and/or 20   [ Time Frame: Week 4-20 post Baseline ]

8.  Secondary:   Change in the VAS Score From Baseline to Week 8, 12, 16 and/or 20.   [ Time Frame: Week 8-20 post Baseline ]


  Serious Adverse Events


  Other Adverse Events


  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
Early termination due to too slow enrollment lead to a small sample size, limiting the ability for confirmatory analysis. All analysis of the primary efficacy endpoint were treated as exploratory.  


Results Point of Contact:  
Name/Title: Manager Public Disclosure
Organization: Merz Pharmaceuticals GmbH
phone: +49 69 1503 865
e-mail: matthias.zerm@merz.de


No publications provided


Responsible Party: Merz Pharmaceuticals GmbH
ClinicalTrials.gov Identifier: NCT00649220     History of Changes
Other Study ID Numbers: MRZ 90001-0716/1, 2007-004489-41
Study First Received: March 27, 2008
Results First Received: August 9, 2011
Last Updated: September 22, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices