A Phase 4 interventional study of Individualized management of AD including caregiver training and Memantine in Alzheimer's Disease, sponsored by NYU Langone Health. Completed at 1 site in United States. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2016-10-25.
Sponsored by NYU Langone Health · Phase 4 and Interventional
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.
3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.
This study's enrollment of 20 is below the median of 70 across 2,808 interventional studies indexed under Alzheimer Disease.
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Exclusion Criteria:
Individualized Management including caregiver training and Memantine
Behavioral: Individualized management of AD including caregiver training · Drug: Memantine
Only Memantine
Drug: Memantine
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.
Also known as: Namenda, Activity therapy, Cognitive stimulation therapy, Exercise, Caregiver support, Alzheimer's, Alzheimer's Disease
Patients receive 10 milligrams of memantine twice daily.
Also known as: Namenda
Change From Baseline in Clinician Interview-Based Assessment of Change Plus Caregiver Input (CIBIC-Plus) Global Score (New York Univeristy Version)
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
Time frame: Baseline to 28 weeks
Change From Baseline in Clinician Interview-Based Assessment of Change Plus Caregiver Input (CIBIC-Plus) Global Score (New York Univeristy Version)
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
Time frame: Baseline to 52 weeks
Change From Baseline of The Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory Modified for Severe Dementia Abbreviated Version (ADCS-ADLsev-abv)
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.
Time frame: Baseline to 28 weeks
Change From Baseline of The Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory Modified for Severe Dementia Abbreviated Version (ADCS-ADLsev-abv)
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.
Time frame: Baseline to 52 weeks
Change From Baseline of the Severe Impairment Battery (SIB)
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).
Time frame: Baseline to 28 weeks
Change From Baseline of the Severe Impairment Battery (SIB)
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).
Time frame: Baseline to 52 weeks
Change From Baseline of the Mini-Mental State Examination (MMSE)
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.
Time frame: Baseline to 28 weeks
Change From Baseline of the Mini-Mental State Examination (MMSE)
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.
Time frame: Baseline to 52 weeks
Change From Baseline of the Functional Assessment Staging Disability Score (FAST-DS)
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)
Time frame: Baseline to 28 weeks
Change From Baseline of the Functional Assessment Staging Disability Score (FAST-DS)
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)
Time frame: Baseline to 52 weeks
Change From Baseline of The Behavioral Pathology in Alzheimer's Disease Frequency Weighted Severity Scale (BEHAVE-AD-FW)
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.
Time frame: Baseline to 28 weeks
Change From Baseline of The Behavioral Pathology in Alzheimer's Disease Frequency Weighted Severity Scale (BEHAVE-AD-FW)
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.
Time frame: Baseline to 52 weeks
Change From Baseline of the Revised Memory and Behavior Problems Checklist (RMBPC): Frequency
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.
Time frame: Baseline to 28 weeks
Change From Baseline of the Revised Memory and Behavior Problems Checklist (RMBPC): Caregiver Reaction
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.
Time frame: Baseline to 28 weeks
Change From Baseline of the Revised Memory and Behavior Problems Checklist (RMBPC): Frequency
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.
Time frame: Baseline to 52 weeks
Change From Baseline of the Revised Memory and Behavior Problems Checklist (RMBPC): Caregiver Reaction
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.
Time frame: Baseline to 52 weeks
| Milestone | Memantine + CIPCM Program | Memantine Alone |
|---|---|---|
| Started | 10 | 10 |
| Completed study; started extension study | 10 | 10 |
| Completed | 10 | 9 |
| Not completed | 0 | 1 |
| Withdrew: Death | 0 | 1 |
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
| units on a scale | Memantine + CIPCM Program | Memantine Alone |
|---|---|---|
| Change From Baseline in Clinician Interview-Based Assessment of Change Plus Caregiver Input (CIBIC-Plus) Global Score (New York Univeristy Version) | 2.3 ± 1.16 | 5.22 ± 1.56 |
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
| units on a scale | Memantine + CIPCM Program | Memantine Alone |
|---|---|---|
| Change From Baseline in Clinician Interview-Based Assessment of Change Plus Caregiver Input (CIBIC-Plus) Global Score (New York Univeristy Version) | 2.1 ± 1.45 | 6 ± 1.32 |
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).
| units on a scale | Memantine + CIPCM Program | Memantine Alone |
|---|---|---|
| Change From Baseline of the Severe Impairment Battery (SIB) | 51.3 ± 33.843 | 54 ± 37.002 |
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).
| units on a scale | Memantine + CIPCM Program | Memantine Alone |
|---|---|---|
| Change From Baseline of the Severe Impairment Battery (SIB) | 45.1 ± 33.365 | 48 ± 37.353 |
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.
| units on a scale | Memantine + CIPCM Program | Memantine Alone |
|---|---|---|
| Change From Baseline of the Mini-Mental State Examination (MMSE) | 6.7 ± 5.143 | 8.4 ± 5.816 |
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.
| units on a scale | Memantine + CIPCM Program | Memantine Alone |
|---|---|---|
| Change From Baseline of the Mini-Mental State Examination (MMSE) | 6.7 ± 4.138 | 6.7 ± 5.477 |
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)
| units on a scale | Memantine + CIPCM Program | Memantine Alone |
|---|---|---|
| Change From Baseline of the Functional Assessment Staging Disability Score (FAST-DS) | 6.16 ± 0.631 | 6.67 ± 0.246 |
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.
| units on a scale | Memantine + CIPCM Program | Memantine Alone |
|---|---|---|
| Change From Baseline of The Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory Modified for Severe Dementia Abbreviated Version (ADCS-ADLsev-abv) | 21.9 ± 8.034 | 9.6 ± 6.041 |
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.
| units on a scale | Memantine + CIPCM Program | Memantine Alone |
|---|---|---|
| Change From Baseline of The Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory Modified for Severe Dementia Abbreviated Version (ADCS-ADLsev-abv) | 18.5 ± 8.045 | 7.6 ± 6.766 |
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)
| units on a scale | Memantine + CIPCM Program | Memantine Alone |
|---|---|---|
| Change From Baseline of the Functional Assessment Staging Disability Score (FAST-DS) | 6.5 ± 0.254 | 6.84 ± 0.279 |
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.
| units on a scale | Memantine + CIPCM Program | Memantine Alone |
|---|---|---|
| Change From Baseline of The Behavioral Pathology in Alzheimer's Disease Frequency Weighted Severity Scale (BEHAVE-AD-FW) | 7.2 ± 5.308 | 23.7 ± 14.952 |
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.
| units on a scale | Memantine + CIPCM Program | Memantine Alone |
|---|---|---|
| Change From Baseline of The Behavioral Pathology in Alzheimer's Disease Frequency Weighted Severity Scale (BEHAVE-AD-FW) | 8.1 ± 5.131 | 21.2 ± 11.893 |
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.
| units on a scale | Memantine + CIPCM Program | Memantine Alone |
|---|---|---|
| Change From Baseline of the Revised Memory and Behavior Problems Checklist (RMBPC): Frequency | 24.7 ± 9.945 | 34.9 ± 9.515 |
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.
| units on a scale | Memantine + CIPCM Program | Memantine Alone |
|---|---|---|
| Change From Baseline of the Revised Memory and Behavior Problems Checklist (RMBPC): Caregiver Reaction | 2.0 ± 2.582 | 10.7 ± 14.143 |
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.
| units on a scale | Memantine + CIPCM Program | Memantine Alone |
|---|---|---|
| Change From Baseline of the Revised Memory and Behavior Problems Checklist (RMBPC): Frequency | 24.4 ± 8.449 | 32.4 ± 11.4 |
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.
| units on a scale | Memantine + CIPCM Program | Memantine Alone |
|---|---|---|
| Change From Baseline of the Revised Memory and Behavior Problems Checklist (RMBPC): Caregiver Reaction | 3.8 ± 6.68 | 11.4 ± 11.599 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Individualized Management and Memantine | — | 3/10 (30%) | 10/10 (100%) |
| Memantine | — | 10/10 (100%) | 10/10 (100%) |
| Event | Individualized Management and Memantine | Memantine |
|---|---|---|
| SyncopeGeneral disorders | 0/10 | 2/10 |
| Left Hip fractureMusculoskeletal and connective tissue disorders | 1/10 | 0/10 |
| FallGeneral disorders | 1/10 | 1/10 |
| OsteoporosisMusculoskeletal and connective tissue disorders | 1/10 | 0/10 |
| DiarrheaInfections and infestations | 0/10 | 1/10 |
| Left heel UlcerSkin and subcutaneous tissue disorders | 0/10 | 1/10 |
| Left heel InfectionInfections and infestations | 0/10 | 1/10 |
| Left Pelvic FractureMusculoskeletal and connective tissue disorders | 0/10 | 1/10 |
| Stage II Pressure UlcerSkin and subcutaneous tissue disorders | 0/10 | 1/10 |
| Small Bowel ObstructionGastrointestinal disorders | 0/10 | 1/10 |
| Event | Individualized Management and Memantine | Memantine |
|---|---|---|
| CoughRespiratory, thoracic and mediastinal disorders | 4/10 | 1/10 |
| DysphagiaGastrointestinal disorders | 0/10 | 4/10 |
| RigidityNervous system disorders | 0/10 | 2/10 |
| Increased alkaline phosphataseInvestigations | 0/10 | 2/10 |
| ColdRespiratory, thoracic and mediastinal disorders | 0/10 | 2/10 |
| HypoglycemiaGeneral disorders | 0/10 | 2/10 |
| abnormal blood resultsInvestigations | 1/10 | 0/10 |
| red blotch on faceSkin and subcutaneous tissue disorders | 1/10 | 0/10 |
| Urinary Tract InfectionInfections and infestations | 1/10 | 0/10 |
| DizzinessGeneral disorders | 1/10 | 1/10 |
| Age, Categorical(Participants) | Individualized Management and Memantine | Memantine | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 1 | 0 | 1 |
| >=65 years | 9 | 10 | 19 |
| Sex: Female, Male(Participants) | Individualized Management and Memantine | Memantine | Total |
|---|---|---|---|
| Female | 8 | 7 | 15 |
| Male | 2 | 3 | 5 |
| Race/Ethnicity, Customized(participants) | Individualized Management and Memantine | Memantine | Total |
|---|---|---|---|
| Hispanic-American | 0 | 2 | 2 |
| White, not of Hispanic-American Origin | 10 | 8 | 18 |
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