Memantine and Comprehensive, Individualized, Patient Centered Management of Alzheimer's Disease: A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change From Baseline in Clinician Interview-Based Assessment of Change Plus Caregiver Input (CIBIC-Plus) Global Score (New York Univeristy Version)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Group 1
Individualized Management including caregiver training and Memantine
干预措施: Individualized management of AD including caregiver training (Behavioral)
Group 1
Individualized Management including caregiver training and Memantine
干预措施: Memantine (Drug)
Group 2
Only Memantine
干预措施: Memantine (Drug)
结局指标
主要结局
Change From Baseline in Clinician Interview-Based Assessment of Change Plus Caregiver Input (CIBIC-Plus) Global Score (New York Univeristy Version)
时间窗: 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
Change From Baseline of The Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory Modified for Severe Dementia Abbreviated Version (ADCS-ADLsev-abv)
时间窗: 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.
次要结局
- Change From Baseline of the Functional Assessment Staging Disability Score (FAST-DS)(Baseline to 52 weeks)
- Change From Baseline of the Severe Impairment Battery (SIB)(Baseline to 52 weeks)
- Change From Baseline of the Revised Memory and Behavior Problems Checklist (RMBPC): Frequency(Baseline to 52 weeks)
- Change From Baseline of the Revised Memory and Behavior Problems Checklist (RMBPC): Caregiver Reaction(Baseline to 52 weeks)
- Change From Baseline of the Mini-Mental State Examination (MMSE)(Baseline to 52 weeks)
- Change From Baseline of The Behavioral Pathology in Alzheimer's Disease Frequency Weighted Severity Scale (BEHAVE-AD-FW)(Baseline to 52 weeks)