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

July 12, 2005
June 3, 2016
August 2006
November 2011   (final data collection date for primary outcome measure)
  • 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 ] [ Designated as safety issue: No ]
    CIBIC-Plus is measured in units on a scale ranging from 1 to 7, where 1 is markedly improved, 4 is unchanged, and 7 is markedly worse
  • 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 ] [ Designated as safety issue: No ]
    CIBIC-Plus is measured in units on a scale ranging from 1 to 7, where 1 is markedly improved, 4 is unchanged, and 7 is markedly worse
  • 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 ] [ Designated as safety issue: No ]
    The ADCS-ADLsev-abv is a structured questionnaire where each item consists of a series of hierarchical questions designed to determine a patient's ability to perform the activities of daily living as assessed by the caregiver. Possible scores range from 0 to 39, where a higher score is indicative of greater capacities.
  • 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 ] [ Designated as safety issue: No ]
    The ADCS-ADLsev-abv is a structured questionnaire where each item consists of a series of hierarchical questions designed to determine a patient's ability to perform the activities of daily living as assessed by the caregiver. Possible scores range from 0 to 39, where a higher score is indicative of greater capacities.
  • (1)Clinician Interview-Based Assessment of Change Plus Caregiver Input (CIBIC-Plus) global score at baseline, 4, 12, and 28 weeks
  • (2)the changes from baseline to week 28 in the Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory modified for severe dementia (ADCS-ADLsev) assessed at 0, 4, 12, 28 weeks.
Complete list of historical versions of study NCT00120874 on ClinicalTrials.gov Archive Site
  • Change From Baseline of the Severe Impairment Battery (SIB) [ Time Frame: Baseline to 28 weeks ] [ Designated as safety issue: No ]
    The SIB evaluates cognitive performance. It is a 51 item scale which assesses social interaction, memory, language, orientation, attention, praxis, visuospacial ability and construction. Scores range from 0 (greatest impairment) to 100 (least impairment).
  • Change From Baseline of the Severe Impairment Battery (SIB) [ Time Frame: Baseline to 52 weeks ] [ Designated as safety issue: No ]
    The SIB evaluates cognitive performance. It is a 51 item scale which assesses social interaction, memory, language, orientation, attention, praxis, visuospacial ability and construction. Scores range from 0 (greatest impairment) to 100 (least impairment).
  • Change From Baseline of the Mini-Mental State Examination (MMSE) [ Time Frame: Baseline to 28 weeks ] [ Designated as safety issue: No ]
    The MMSE is a graded on a 30 point scale that measures cognitive functioning. A lower score indicates a higher level of impairment. Complete scale range is -no cognitive impairment=24-30; mild cognitive impairment=18-23; severe cognitive impairment=0-17.
  • Change From Baseline of the Mini-Mental State Examination (MMSE) [ Time Frame: Baseline to 52 weeks ] [ Designated as safety issue: No ]
    The MMSE is a graded on a 30 point scale that measures cognitive functioning. A lower score indicates a higher level of impairment.
  • Change From Baseline of the Functional Assessment Staging Disability Score (FAST-DS) [ Time Frame: Baseline to 28 weeks ] [ Designated as safety issue: No ]

    The FAST-DS assesses the magnitude of progressive functional deterioration by identifying characteristic progressive disabilities in participants with AD. Scores range from 1.0 (normal) to 7f (severe loss of ability, not even able to hold up head independently). Scores are made up of stages (1 through 7) and substages (from a to e for stage 6; from a to f for stage 7). The following scoring for substages is applied: 6a=6.0, 6b=6.2, 6c=6.4, 6d=6.6, 6e=6.8, 7a=7.0, 7b=7.2, 7c=7.4, 7d=7.6, 7e=7.8, 7f=8.0. Additionally, non-consecutive deficits are noted and scored as follows: full stage non-consecutive deficit=1.0, non-consecutive substage deficit=0.2.

    The overall FAST-DS score = (FAST Stage Score) + (Each Non-Consecutive FAST disability scored as described)

  • Change From Baseline of the Functional Assessment Staging Disability Score (FAST-DS) [ Time Frame: Baseline to 52 weeks ] [ Designated as safety issue: No ]

    The FAST-DS assesses the magnitude of progressive functional deterioration by identifying characteristic progressive disabilities in participants with AD. Scores range from 1.0 (normal) to 7f (severe loss of ability, not even able to hold up head independently). Scores are made up of stages (1 through 7) and substages (from a to e for stage 6; from a to f for stage 7). The following scoring for substages is applied: 6a=6.0, 6b=6.2, 6c=6.4, 6d=6.6, 6e=6.8, 7a=7.0, 7b=7.2, 7c=7.4, 7d=7.6, 7e=7.8, 7f=8.0. Additionally, non-consecutive deficits are noted and scored as follows: full stage non-consecutive deficit=1.0, non-consecutive substage deficit=0.2.

    The overall FAST-DS score = (FAST Stage Score) + (Each Non-Consecutive FAST disability scored as described)

  • Change From Baseline of The Behavioral Pathology in Alzheimer's Disease Frequency Weighted Severity Scale (BEHAVE-AD-FW) [ Time Frame: Baseline to 28 weeks ] [ Designated as safety issue: No ]
    The BEHAVE-AD-FW measures the frequency and severity of 25 behavioral symptoms with a total score and global rating. Individual behavioral assessments are rated for severity (0=none to 3-most severe) and frequency (1=least frequent to 4=most frequent) which are then multiplied; scores for each of the 25 items are then summed. Possible total scores range from 0 to 297. The global rating is scored from 0 (not dangerous to patient, not troubling to caregiver) to 3 (dangerous to patient, highly troubling to caregiver). Global rating was not analyzed for this study. The higher the score the worse the outcome.
  • Change From Baseline of The Behavioral Pathology in Alzheimer's Disease Frequency Weighted Severity Scale (BEHAVE-AD-FW) [ Time Frame: Baseline to 52 weeks ] [ Designated as safety issue: No ]
    The BEHAVE-AD-FW measures the frequency and severity of 25 behavioral symptoms with a total score and global rating. Individual behavioral assessments are rated for severity (0=none to 3-most severe) and frequency (1=least frequent to 4=most frequent) which are then multiplied; scores for each of the 25 items are then summed. Possible total scores range from 0 to 297. The global rating is scored from 0 (not dangerous to patient, not troubling to caregiver) to 3 (dangerous to patient, highly troubling to caregiver). The higher the score the worse the outcome.
  • Change From Baseline of the Revised Memory and Behavior Problems Checklist (RMBPC): Frequency [ Time Frame: Baseline to 28 weeks ] [ Designated as safety issue: No ]
    The RMBPC is a 24 item rating scale of the frequency of memory and behavioral problems in the AD subject and of how upset or "bothered" their caregivers react. Frequency is rated from 0 (least frequent) to 4 (most frequent) and caregiver reaction is rated from 0 (not at all) to 4 (extremely bothered or upset). Higher scores indicate more frequent memory and behavioral problems in the subject with AD as well as a more upset or bothered caregiver. Possible scores range from 0 to 96.
  • Change From Baseline of the Revised Memory and Behavior Problems Checklist (RMBPC): Caregiver Reaction [ Time Frame: Baseline to 28 weeks ] [ Designated as safety issue: No ]
    The RMBPC is a 24 item rating scale of the frequency of memory and behavioral problems in the AD subject and of how upset or "bothered" their caregivers react. Frequency is rated from 0 (least frequent) to 4 (most frequent) and caregiver reaction is rated from 0 (not at all) to 4 (extremely bothered or upset). Higher scores indicate more frequent memory and behavioral problems in the subject with AD as well as a more upset or bothered caregiver. Possible scores range from 0 to 96.
  • Change From Baseline of the Revised Memory and Behavior Problems Checklist (RMBPC): Frequency [ Time Frame: Baseline to 52 weeks ] [ Designated as safety issue: No ]
    The RMBPC is a 24 item rating scale of the frequency of memory and behavioral problems in the AD subject and of how upset or "bothered" their caregivers react. Frequency is rated from 0 (least frequent) to 4 (most frequent) and caregiver reaction is rated from 0 (not at all) to 4 (extremely bothered or upset). Higher scores indicate more frequent memory and behavioral problems in the subject with AD as well as a more upset or bothered caregiver. Possible scores range from 0 to 96.
  • Change From Baseline of the Revised Memory and Behavior Problems Checklist (RMBPC): Caregiver Reaction [ Time Frame: Baseline to 52 weeks ] [ Designated as safety issue: No ]
    The RMBPC is a 24 item rating scale of the frequency of memory and behavioral problems in the AD subject and of how upset or "bothered" their caregivers react. Frequency is rated from 0 (least frequent) to 4 (most frequent) and caregiver reaction is rated from 0 (not at all) to 4 (extremely bothered or upset). Higher scores indicate more frequent memory and behavioral problems in the subject with AD as well as a more upset or bothered caregiver. Possible scores range from 0 to 96.
  • (1)Severe Impairment Battery
  • (2)Mini-Mental State Examination
  • (3)Functional Assessment Staging
  • (4)Global Deterioration Scale
  • (5)Behavioral Pathology in Alzheimer's Disease-Frequency Weighted
  • (6)Memory and Behavior Problems Checklist
  • All secondary outcomes scored at baseline, 4, 12, and 28 weeks
Not Provided
Not Provided
 
Memantine and Comprehensive, Individualized Management of Alzheimer's Disease and Caregiver Training
Memantine and Comprehensive, Individualized, Patient Centered Management of Alzheimer's Disease: A Randomized Controlled Trial
The purpose of this study is to determine whether a comprehensive, individualized management approach with caregiver training and medication with memantine will alleviate symptoms in community dwelling patients with moderate to severe Alzheimer's disease.

Presently some 4.5 million people are afflicted with Alzheimer's disease in the United States. At present pharmacologic treatment, although beneficial, is not curative. Certain nonpharmacologic treatments have assisted caregivers of AD patients by reducing their stress and burden, and others have aided patients, by improving their mood and physical functioning. Comprehensive, individualized approaches to improving Alzheimer's patients' symptomatology and caregiver stress and burden have not been systematically investigated in Alzheimer's patient care. This study seeks to train and counsel caregivers as well as develop an individualized, comprehensive management program that will seek to enhance the functioning of each patient participant.

Patients are randomly placed into one of two groups. Both groups receive memantine and comprehensive evaluations at baseline, 4, 12,28 and 52 weeks. Additionally, group 1 receives an individualized management program, which 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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Alzheimer's Disease
  • Behavioral: 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.
    Other Names:
    • Namenda
    • Activity therapy
    • Cognitive stimulation therapy
    • Exercise
    • Caregiver support
    • Alzheimer's
    • Alzheimer's Disease
  • Drug: Memantine
    Patients receive 10 milligrams of memantine twice daily.
    Other Name: Namenda
  • Experimental: Group 1
    Individualized Management including caregiver training and Memantine
    Interventions:
    • Behavioral: Individualized management of AD including caregiver training
    • Drug: Memantine
  • Active Comparator: Group 2
    Only Memantine
    Intervention: Drug: Memantine

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
November 2011
November 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients, 50 years of age or greater, residing in the community
  • Presence of a family and/or professional caregiver willing and able to participate in all aspects of this study
  • A diagnosis of probable Alzheimer's disease by Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV) and NINCDS-ADRDA (McKhann,et al., Neurology,1984;34: 939-944) criteria
  • A CT or MRI brain scan and medical work up compatible with the DSM-IV and NINCDS-ADRDA diagnostic criteria for Alzheimer's disease
  • Mini-Mental State Examination scores of 3-14
  • Global Deterioration Scale stages of 5 or 6
  • A stage of 6a or greater on the Functional Assessment Staging instrument signifying the presence of dementia deficits in the ability to perform one or more basic activities of daily living

Exclusion Criteria:

  • Non-English speaking patients and/or caregivers
  • Subjects with a diagnosis of dementia due to conditions other than Alzheimer's disease.
  • Subjects with a diagnosis of vascular dementia or a score greater than 4 on the modified Hachinski Ischemic Rating scale
  • Patients with a major depressive disorder
  • Patients with clinically significant laboratory abnormalities
  • Patients receiving investigational pharmacologic agents
Both
50 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00120874
H12444-01 A, NAM MD 18
Yes
Not Provided
Not Provided
New York University School of Medicine
New York University School of Medicine
  • Forest Laboratories
  • Fisher Center for Alzheimer's Research Foundation
Principal Investigator: Barry Reisberg, M.D. New York University School of Medicine
Study Director: Sunnie Kenowsky, D.V.M. New York University School of Medicine
New York University School of Medicine
June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP