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Completed

NCT Number: NCT00120874

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

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.

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Key information

Conditions

Alzheimer's Disease Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Fisher Alzheimer's Program, New York University School of Medicine

New York, 10016, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Individualized management of AD including caregiver training

Behavioral

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

Memantine

Drug

Patients receive 10 milligrams of memantine twice daily.

Other names: Namenda

Primary outcomes

  1. 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

    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

  2. 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

    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

  3. 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

    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.

  4. 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

    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.

Secondary outcomes

  1. Change From Baseline of the Severe Impairment Battery (SIB)

    Time frame: Baseline to 28 weeks

    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).

  2. Change From Baseline of the Severe Impairment Battery (SIB)

    Time frame: Baseline to 52 weeks

    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).

  3. Change From Baseline of the Mini-Mental State Examination (MMSE)

    Time frame: Baseline to 28 weeks

    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.

  4. Change From Baseline of the Mini-Mental State Examination (MMSE)

    Time frame: Baseline to 52 weeks

    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.

  5. Change From Baseline of the Functional Assessment Staging Disability Score (FAST-DS)

    Time frame: Baseline to 28 weeks

    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)

  6. Change From Baseline of the Functional Assessment Staging Disability Score (FAST-DS)

    Time frame: Baseline to 52 weeks

    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)

  7. Change From Baseline of The Behavioral Pathology in Alzheimer's Disease Frequency Weighted Severity Scale (BEHAVE-AD-FW)

    Time frame: Baseline to 28 weeks

    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.

  8. Change From Baseline of The Behavioral Pathology in Alzheimer's Disease Frequency Weighted Severity Scale (BEHAVE-AD-FW)

    Time frame: Baseline to 52 weeks

    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.

  9. Change From Baseline of the Revised Memory and Behavior Problems Checklist (RMBPC): Frequency

    Time frame: Baseline to 28 weeks

    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.

  10. Change From Baseline of the Revised Memory and Behavior Problems Checklist (RMBPC): Caregiver Reaction

    Time frame: Baseline to 28 weeks

    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.

  11. Change From Baseline of the Revised Memory and Behavior Problems Checklist (RMBPC): Frequency

    Time frame: Baseline to 52 weeks

    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.

  12. Change From Baseline of the Revised Memory and Behavior Problems Checklist (RMBPC): Caregiver Reaction

    Time frame: Baseline to 52 weeks

    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.

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

  • Fisher Center for Alzheimer's Research Foundation
  • Forest Laboratories

Registry information

Official study title

Memantine and Comprehensive, Individualized, Patient Centered Management of Alzheimer's Disease: A Randomized Controlled Trial

Important dates

Study start
2006
Primary completion
2011
Study completion
2011
First posted
Jul 19, 2005
Registry last updated
Oct 25, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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