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
研究概览
地位
条件
详细说明
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.
研究类型
注册 (实际的)
阶段
- 第四阶段
联系人和位置
学习地点
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New York
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New York、New York、美国、10016
- Fisher Alzheimer's Program, New York University School of Medicine
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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
学习计划
研究是如何设计的？
设计细节
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Group 1
Individualized Management including caregiver training and Memantine
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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.
其他名称：
Patients receive 10 milligrams of memantine twice daily.
其他名称：
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有源比较器：Group 2
Only Memantine
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Patients receive 10 milligrams of memantine twice daily.
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change From Baseline in Clinician Interview-Based Assessment of Change Plus Caregiver Input (CIBIC-Plus) Global Score (New York Univeristy Version)
大体时间：Baseline to 28 weeks
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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
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Baseline to 28 weeks
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Change From Baseline in Clinician Interview-Based Assessment of Change Plus Caregiver Input (CIBIC-Plus) Global Score (New York Univeristy Version)
大体时间：Baseline to 52 weeks
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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
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Baseline to 52 weeks
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Change From Baseline of The Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory Modified for Severe Dementia Abbreviated Version (ADCS-ADLsev-abv)
大体时间：Baseline to 28 weeks
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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.
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Baseline to 28 weeks
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Change From Baseline of The Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory Modified for Severe Dementia Abbreviated Version (ADCS-ADLsev-abv)
大体时间：Baseline to 52 weeks
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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.
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Baseline to 52 weeks
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change From Baseline of the Severe Impairment Battery (SIB)
大体时间：Baseline to 28 weeks
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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).
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Baseline to 28 weeks
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Change From Baseline of the Severe Impairment Battery (SIB)
大体时间：Baseline to 52 weeks
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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).
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Baseline to 52 weeks
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Change From Baseline of the Mini-Mental State Examination (MMSE)
大体时间：Baseline to 28 weeks
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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.
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Baseline to 28 weeks
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Change From Baseline of the Mini-Mental State Examination (MMSE)
大体时间：Baseline to 52 weeks
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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.
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Baseline to 52 weeks
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Change From Baseline of the Functional Assessment Staging Disability Score (FAST-DS)
大体时间：Baseline to 28 weeks
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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
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Change From Baseline of the Functional Assessment Staging Disability Score (FAST-DS)
大体时间：Baseline to 52 weeks
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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
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Change From Baseline of The Behavioral Pathology in Alzheimer's Disease Frequency Weighted Severity Scale (BEHAVE-AD-FW)
大体时间：Baseline to 28 weeks
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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.
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Baseline to 28 weeks
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Change From Baseline of The Behavioral Pathology in Alzheimer's Disease Frequency Weighted Severity Scale (BEHAVE-AD-FW)
大体时间：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.
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Baseline to 52 weeks
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Change From Baseline of the Revised Memory and Behavior Problems Checklist (RMBPC): Frequency
大体时间：Baseline to 28 weeks
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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.
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Baseline to 28 weeks
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Change From Baseline of the Revised Memory and Behavior Problems Checklist (RMBPC): Caregiver Reaction
大体时间：Baseline to 28 weeks
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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.
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Baseline to 28 weeks
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Change From Baseline of the Revised Memory and Behavior Problems Checklist (RMBPC): Frequency
大体时间：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.
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Baseline to 52 weeks
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Change From Baseline of the Revised Memory and Behavior Problems Checklist (RMBPC): Caregiver Reaction
大体时间：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.
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Baseline to 52 weeks
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合作者和调查者
调查人员
- 首席研究员：Barry Reisberg, M.D.、NYU Langone Health
- 研究主任：Sunnie Kenowsky, D.V.M.、NYU Langone Health
出版物和有用的链接
一般刊物
- 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.
- 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.
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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