Memantine and Comprehensive, Individualized Management of Alzheimer's Disease and Caregiver Training

This study has been completed.
Sponsor:
Collaborators:
Forest Laboratories
Fisher Center for Alzheimer's Research Foundation
Information provided by (Responsible Party):
New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT00120874
First received: July 12, 2005
Last updated: June 3, 2016
Last verified: June 2016
Results First Received: April 28, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor)
Condition: Alzheimer's Disease
Interventions: Behavioral: Individualized management of AD including caregiver training
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 + CIPCM Program

Individualized Management including caregiver training and Memantine

Individualized management of AD including caregiver training: Individualized management program: consists of home visits to get the patient exercising, doing enjoyable activities and cognitive stimulation, educational sessions for caregivers on coping with difficult situations and a caregiver support group to help with questions and emotional concerns.

Memantine: Patients receive 10 milligrams of memantine twice daily.

Memantine Alone

Only Memantine

Memantine: Patients receive 10 milligrams of memantine twice daily.


Participant Flow:   Overall Study
    Memantine + CIPCM Program     Memantine Alone  
STARTED     10     10  
COMPLETED     10     9  
NOT COMPLETED     0     1  
Death                 0                 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
Individualized Management and Memantine

Individualized Management including caregiver training and Memantine

Individualized management of AD including caregiver training: Individualized management program: consists of home visits to get the patient exercising, doing enjoyable activities and cognitive stimulation, educational sessions for caregivers on coping with difficult situations and a caregiver support group to help with questions and emotional concerns.

Memantine: Patients receive 10 milligrams of memantine twice daily.

Memantine

Only Memantine

Memantine: Patients receive 10 milligrams of memantine twice daily.

Total Total of all reporting groups

Baseline Measures
    Individualized Management and Memantine     Memantine     Total  
Number of Participants  
[units: participants]
  10     10     20  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     1     0     1  
>=65 years     9     10     19  
Gender  
[units: participants]
     
Female     8     7     15  
Male     2     3     5  
Race/Ethnicity, Customized  
[units: participants]
     
Hispanic-American     0     2     2  
White, not of Hispanic-American Origin     10     8     18  



  Outcome Measures
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1.  Primary:   Change From Baseline in Clinician Interview-Based Assessment of Change Plus Caregiver Input (CIBIC-Plus) Global Score (New York Univeristy Version)   [ Time Frame: Baseline to 28 weeks ]

2.  Primary:   Change From Baseline in Clinician Interview-Based Assessment of Change Plus Caregiver Input (CIBIC-Plus) Global Score (New York Univeristy Version)   [ Time Frame: Baseline to 52 weeks ]

3.  Primary:   Change From Baseline of The Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory Modified for Severe Dementia Abbreviated Version (ADCS-ADLsev-abv)   [ Time Frame: Baseline to 28 weeks ]

4.  Primary:   Change From Baseline of The Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory Modified for Severe Dementia Abbreviated Version (ADCS-ADLsev-abv)   [ Time Frame: Baseline to 52 weeks ]

5.  Secondary:   Change From Baseline of the Severe Impairment Battery (SIB)   [ Time Frame: Baseline to 28 weeks ]

6.  Secondary:   Change From Baseline of the Severe Impairment Battery (SIB)   [ Time Frame: Baseline to 52 weeks ]

7.  Secondary:   Change From Baseline of the Mini-Mental State Examination (MMSE)   [ Time Frame: Baseline to 28 weeks ]

8.  Secondary:   Change From Baseline of the Mini-Mental State Examination (MMSE)   [ Time Frame: Baseline to 52 weeks ]

9.  Secondary:   Change From Baseline of the Functional Assessment Staging Disability Score (FAST-DS)   [ Time Frame: Baseline to 28 weeks ]

10.  Secondary:   Change From Baseline of the Functional Assessment Staging Disability Score (FAST-DS)   [ Time Frame: Baseline to 52 weeks ]

11.  Secondary:   Change From Baseline of The Behavioral Pathology in Alzheimer's Disease Frequency Weighted Severity Scale (BEHAVE-AD-FW)   [ Time Frame: Baseline to 28 weeks ]

12.  Secondary:   Change From Baseline of The Behavioral Pathology in Alzheimer's Disease Frequency Weighted Severity Scale (BEHAVE-AD-FW)   [ Time Frame: Baseline to 52 weeks ]

13.  Secondary:   Change From Baseline of the Revised Memory and Behavior Problems Checklist (RMBPC): Frequency   [ Time Frame: Baseline to 28 weeks ]

14.  Secondary:   Change From Baseline of the Revised Memory and Behavior Problems Checklist (RMBPC): Caregiver Reaction   [ Time Frame: Baseline to 28 weeks ]

15.  Secondary:   Change From Baseline of the Revised Memory and Behavior Problems Checklist (RMBPC): Frequency   [ Time Frame: Baseline to 52 weeks ]

16.  Secondary:   Change From Baseline of the Revised Memory and Behavior Problems Checklist (RMBPC): Caregiver Reaction   [ Time Frame: Baseline to 52 weeks ]


  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
The original statistician who worked on this study left the institution prior to completing data analysis. A new statistician has been engaged. In the unlikely event that outcome measures data changes, it will be updated accordingly in this record.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Barry Reisberg
Organization: NYU Langone Medical Center
phone: 121-263-8550
e-mail: barry.reisberg@nyumc.org


Publications:

Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT00120874     History of Changes
Other Study ID Numbers: H12444-01 A
NAM MD 18 ( Other Grant/Funding Number: Forest Laboratories )
Study First Received: July 12, 2005
Results First Received: April 28, 2016
Last Updated: June 3, 2016
Health Authority: United States: Institutional Review Board