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| ID | Type | Description | Link |
|---|---|---|---|
| NAM MD 18 | Other Grant/Funding Number | Forest Laboratories |
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| Name | Class |
|---|---|
| Forest Laboratories | INDUSTRY |
| Fisher Center for Alzheimer's Research Foundation | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | Individualized Management including caregiver training and Memantine |
|
| Group 2 | Active Comparator | Only Memantine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | 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. | 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. | Baseline to 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline to 28 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Barry Reisberg, M.D. | NYU Langone Health | Principal Investigator |
| Sunnie Kenowsky, D.V.M. | NYU Langone Health | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fisher Alzheimer's Program, New York University School of Medicine | New York | New York | 10016 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10189596 | Background | Reisberg B, Kenowsky S, Franssen EH, Auer SR, Souren LE. Towards a science of Alzheimer's disease management: a model based upon current knowledge of retrogenesis. Int Psychogeriatr. 1999 Mar;11(1):7-23. doi: 10.1017/s1041610299005554. | |
| 14559955 | Background | Teri L, Gibbons LE, McCurry SM, Logsdon RG, Buchner DM, Barlow WE, Kukull WA, LaCroix AZ, McCormick W, Larson EB. Exercise plus behavioral management in patients with Alzheimer disease: a randomized controlled trial. JAMA. 2003 Oct 15;290(15):2015-22. doi: 10.1001/jama.290.15.2015. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Memantine Alone | Only Memantine Memantine: Patients receive 10 milligrams of memantine twice daily. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Mean | Standard Deviation | units on a scale | Baseline to 28 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Left Hip fracture | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| abnormal blood results | Investigations | Systematic Assessment | slightly low copper, low zinc, mild elevation of serotonin |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Barry Reisberg | NYU Langone Medical Center | 121-263-8550 | barry.reisberg@nyumc.org |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D003704 | Dementia |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
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| ID | Term |
|---|---|
| D008559 | Memantine |
| D015444 | Exercise |
| D016564 | Amyloid beta-Protein Precursor |
| ID | Term |
|---|---|
| D000547 | Amantadine |
| D000218 | Adamantane |
| D001952 | Bridged-Ring Compounds |
| D006844 | Hydrocarbons, Cyclic |
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|
|
| Memantine | Drug | Patients receive 10 milligrams of memantine twice daily. |
|
|
| 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). |
| 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. | 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. | 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) | 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) | 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. | 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. | 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. | 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. | 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. | 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. | Baseline to 52 weeks |
| BG001 | Memantine | Only Memantine Memantine: Patients receive 10 milligrams of memantine twice daily. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| OG001 | Memantine Alone | Only Memantine Memantine: Patients receive 10 milligrams of memantine twice daily. |
|
|
| Primary | 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 | Posted | Mean | Standard Deviation | units on a scale | Baseline to 52 weeks |
|
|
|
| Secondary | 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). | Posted | Mean | Standard Deviation | units on a scale | Baseline to 28 weeks |
|
|
|
| Secondary | 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). | Posted | Mean | Standard Deviation | units on a scale | Baseline to 52 weeks |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline to 28 weeks |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline to 52 weeks |
|
|
|
| Secondary | 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) | Posted | Mean | Standard Deviation | units on a scale | Baseline to 28 weeks |
|
|
|
| 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) | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline to 28 weeks |
|
|
|
| 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) | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline to 52 weeks |
|
|
|
| Secondary | 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) | Posted | Mean | Standard Deviation | units on a scale | Baseline to 52 weeks |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline to 28 weeks |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline to 52 weeks |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline to 28 weeks |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline to 28 weeks |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline to 52 weeks |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline to 52 weeks |
|
|
|
| 3 |
| 10 |
| 10 |
| 10 |
| EG001 | Memantine | Only Memantine Memantine: Patients receive 10 milligrams of memantine twice daily. | 10 | 10 | 10 | 10 |
| Fall | General disorders | Non-systematic Assessment |
|
| Osteoporosis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Diarrhea | Infections and infestations | Systematic Assessment | C. dificil infection |
|
| Left heel Ulcer | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Left heel Infection | Infections and infestations | Non-systematic Assessment |
|
| Left Pelvic Fracture | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Stage II Pressure Ulcer | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Located above Anus to tail bone |
|
| Small Bowel Obstruction | Gastrointestinal disorders | Systematic Assessment | Hospitalized, determined by CT scan |
|
| Urinary tract Infection | Infections and infestations | Systematic Assessment | No growth on Culture and sensitivity |
|
| Dehydration | General disorders | Systematic Assessment |
|
| Cardiopulmonary Arrest | General disorders | Systematic Assessment | Unexpected event |
|
| Atherosclerotic Heart Disease | General disorders | Systematic Assessment | Vascular disorders Cardiac disorders |
|
| Syncope | General disorders | Systematic Assessment | 1 Subject had 2 episodes & was placed in hospice. 2nd subject had 2 syncopal episodes, 1 at a restaurant & 2nd episode in Dr. office |
|
|
| red blotch on face | Skin and subcutaneous tissue disorders | Non-systematic Assessment | lasted 2-3 hours |
|
| Urinary Tract Infection | Infections and infestations | Systematic Assessment | Treated with antibiotics |
|
| Dizziness | General disorders | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Diarrhea | Infections and infestations | Systematic Assessment | C. dificil |
|
| Fungal skin rash in groin | Infections and infestations | Systematic Assessment |
|
| toenail fungal infection | Infections and infestations | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
|
| Calcified bone mass on hip due to muscle tear | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| abnormal urine analysis | Investigations | Systematic Assessment | possible urinary tract infection |
|
| Vitamin D insufficiency | General disorders | Systematic Assessment |
|
| Rigidity | Nervous system disorders | Systematic Assessment | 1 subject had Parkinsonian symptoms of rigidity and instability, a second subject had rigidity possibly due to supplement usage |
|
| Abnormal sensation in hands | Nervous system disorders | Systematic Assessment |
|
| Increasing hypothyroidism | Endocrine disorders | Systematic Assessment | Subject was euthyroid at baseline on medication & later diagnosed with hypothyroidism |
|
| Increased alkaline phosphatase | Investigations | Systematic Assessment | 1 subject had an increased alkaline phosphatase at 2 study visits, a second subject had an elevated alkaline phosphatase at 1 visit |
|
| Constipation | Gastrointestinal disorders | Non-systematic Assessment | 3 subjects each had 1 episode of constipation reported by caregiver, a 4th subject had 1 episode determined by hosp dr, a 5th subject had chronic constipation reported once, |
|
| Elevated Platelet Count | Blood and lymphatic system disorders | Systematic Assessment |
|
| Black blister on Left heel | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | Non-systematic Assessment | 4 subjects were reported to have difficulty swallowing pills. |
|
| Brown liquid coming from nose | General disorders | Non-systematic Assessment | Occurred simultaneously with diarrhea |
|
| Sleepiness | General disorders | Non-systematic Assessment |
|
| Decreased appetite | General disorders | Non-systematic Assessment | 1 subject had dec appetite in general once starting carbidopa/levodopa, a 2nd subject stopped eating for 2 days then had a decreased appetite afterwards |
|
| Electrolyte abnormality | General disorders | Systematic Assessment | elevated calcium |
|
| Hearing Loss | Ear and labyrinth disorders | Non-systematic Assessment | 1 subject developed hearing loss when started taking Namenda |
|
| Increased leg edema | General disorders | Non-systematic Assessment | 1 subject had mild leg edema at baseline and it was reported to have worsened at Wk 4 study visit |
|
| Cold | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | 1 subject had 1 episode,a 2nd subject had 2 episodes, |
|
| Stage I Pressure Sore | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Skin rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Dehydration | General disorders | Systematic Assessment | 1 subject had 2 episodes which occurred concurrently with syncope and hypotension |
|
| Hypotension | General disorders | Systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Fall | General disorders | Non-systematic Assessment | 1 subject fell out of bed |
|
| Bruised ribs | Musculoskeletal and connective tissue disorders | Systematic Assessment | 1 subject from falling out of bed. Dx on PE by Dr. |
|
| Buttocks abscess | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Buttocks ulcer | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Elevated creatinine and decreased GFR | Investigations | Systematic Assessment |
|
| Hypoglycemia | General disorders | Systematic Assessment | 1 subject had 1 asymptomatic episode on Wk 4 bloodwork, 1 subject had mild hypoglycemia |
|
| Elevated C Reactive Protein | General disorders | Systematic Assessment | Cause not found |
|
| mild hypercholesterolemia | Investigations | Systematic Assessment |
|
| Chest congestion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | CT scan |
|
| Adipsia | General disorders | Non-systematic Assessment | Lasted 2 days |
|
| Lost ability to walk | General disorders | Non-systematic Assessment | Occurred simultaneously with syncopal event |
|
| Lip smacking and chomping | General disorders | Non-systematic Assessment | Occurred continuously, reported at 2 study visits wk4 & wk12 |
|
| Skin tear | Skin and subcutaneous tissue disorders | Non-systematic Assessment | RLE |
|
| Abrasion | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Right hip |
|
Not provided
Not provided
Not provided
| D019636 |
| Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| D058227 | Amyloidogenic Proteins |
| D000682 | Amyloid |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D008565 | Membrane Proteins |
| D011498 | Protein Precursors |
| D058255 | Protease Nexins |
| D053491 | Proteinase Inhibitory Proteins, Secretory |