Distinguishing Between Alzheimer's Disease, Lewy Body Dementia, and Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Wechsler Adult Intelligence Scale 4th edition (WAIS-4) Block Design
研究概览
简要总结
The study is designed to characterize the clinical, neuropsychological, polysomnographic, and neuroimaging findings among subjects with Alzheimer's disease, Lewy Body dementia, and Parkinsons' Disease.
详细描述
The study will use structural and functional MRIs, daTscans, fluorodeoxyglucose (FDG) PET scans, Amyvid PET scans, polysomnographs, neuropsychological testing, cerebrospinal fluid in willing participants to distinguish between a diagnosis of Alzheimer's disease, Lewy Body dementia, and Parkinson's Disease. All subjects will have a clinical evaluation, physical examination including vital signs and orthostatic blood pressures and pulses, neurological examination including UPDRS evaluation, genetic blood sample collection, neuropsychological testing, polysomnogram, and neuroimaging. The study partner will also be interviewed for completion of all of the behavioral and functional measures.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must meet the standard clinical criteria of the syndromes of interest
- •All subjects must have enough cognitive abilities to complete study procedures, which will be operationally defined as having a Mini Mental State Examination (MMSE) score greater or equal to
- •Subjects must be on stable cognitive and psychoactive medication regimen for the preceding four weeks of enrollment.
- •Subjects must have a responsible study partner that either lives with them or is in regular contact with them at least 4 out of 7 days per week.
- •Subjects must have visual and auditory acuity adequate for testing.
排除标准
- •Any other condition (other than the primary diagnosis), which in the opinion of the investigators might contribute to the syndrome of dementia or complicate its assessment.
- •active medical disorder that could preclude participation in this protocol
- •Women who are pregnant or are breast feeding
- •severe renal impairment as defined by glomerular filtration rate (GFR) less than 30 (may have increased radiation exposure with the DaTscan).
- •Subjects in whom English is not the 1st language
- •Subjects with educational level less than 12 years
- •Subjects who have ever participated in an experimental study with an amyloid targeting agent unless it can be documented that the subject received only placebo during the course of the trial.
结局指标
主要结局
Wechsler Adult Intelligence Scale 4th edition (WAIS-4) Block Design
时间窗: Baseline
Neuropsychological measure of visuospatial perception/ reasoning
Wechsler Memory Scale 3rd ed. (WAIS-3) Logical Memory 1 & 2
时间窗: Baseline
Neuropsychological measure of memory
Boston Naming Test
时间窗: Baseline
Neuropsychological measure of language
Wisconsin Card Sorting Task
时间窗: Baseline
Neuropsychological measure of executive functioning
Clinical Dementia Rating Scale (CDR)
时间窗: Baseline
Global cognitive and functional measure
Mayo Sleep Questionnaire-Informant
时间窗: Baseline
Sleep measure
Wechsler Adult Intelligence Scale 4th edition (WAIS-4) Matrix Reasoning
时间窗: Baseline
Neuropsychological measure of executive functioning
Wechsler Adult Intelligence Scale 4th edition (WAIS-4) Reliable Digits (embedded measure)
时间窗: Baseline
Neuropsychological measure of effort
Judgment of Line Orientation Standardized Test
时间窗: Baseline
Neuropsychological measure of visuospatial perception/ reasoning
Brief Visuospatial Memory Test (BVMT)
时间窗: Baseline
Neuropsychological measure of memory
California Verbal Learning Test (CVLT-2)
时间窗: Baseline
Neuropsychological measure of memory
Self Administered Gerocognitive Examination- A brief cognitive assessment instrument for mild cognitive impairment and early dementia
时间窗: Baseline
Global neuropsychological measure
Apolipoprotein E (APOE) Genotyping of a whole blood sample
时间窗: Baseline
10 ml of whole blood will be drawn for APOE genotyping
The Activities of Daily Living (ADL) Standardized Scale
时间窗: Baseline
Functional measure
Mayo Fluctuations Scale
时间窗: Baseline
Behavioral measure
Functional Outcomes of Sleep Questionnaire-10
时间窗: Baseline
Sleep measure
Berg Balance Scale (BBS)
时间窗: Baseline
Gait, Mobility, and Coordination Measure
Brain MRI
时间窗: Baseline
Imaging including a resting state functional MRI, diffusion tensor imaging, and anatomic imaging
Beck Depression Inventory 2nd ed.
时间窗: Baseline
Behavioral measure
The Modified Somatic Perception Questionnaire
时间窗: Baseline
Behavioral measure
The Epworth Sleepiness Scale
时间窗: Baseline
Sleep measure
Florbetapir (F18-AV-45) positron emission tomography (amyloid PET)
时间窗: Baseline
Imaging to determine extent of amyloid deposition
Single-photon emission computed tomography (SPECT) with the radioligand [123I]FP-CIT
时间窗: Baseline
Functional imaging of the dopamine transporter
Wechsler Memory Scale 3rd ed. (WAIS-3) Spatial Span
时间窗: Baseline
Neuropsychological measure of attention
Trail Making Test A
时间窗: Baseline
Neuropsychological measure of executive functioning/psychomotor processing speed
Controlled Oral Word Association Test (COWAT)- Animal Naming
时间窗: Baseline
Neuropsychological measure of language/verbal fluency
California Verbal Learning Test (CVLT-2) Forced Choice (embedded measure)
时间窗: Baseline
Neuropsychological measure of effort
Neuropsychiatric Inventory (NPI)
时间窗: Baseline
Behavioral measure
Part III and IV of the Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
时间窗: Baseline
Gait, Mobility, and Coordination Measure
Positron emission tomography with 2-(18F) fluoro-2-deoxy-d-glucose (FDG-PET)
时间窗: Baseline
Imaging to determine total and regional cerebral glucose metabolism
Polysomnogram
时间窗: Baseline
participants will have an overnight standard clinical polysomnogram with added limb leads assessing for presence of sleep apnea, periodic limb movements, and rapid eye movement (REM) sleep characteristics
Mini Mental State Examination (MMSE-1)
时间窗: Baseline
Global neuropsychological measure
Wechsler Adult Intelligence Scale 4th edition (WAIS-4) Vocabulary
时间窗: Baseline
Neuropsychological measure of premorbid IQ estimate
Wechsler Adult Intelligence Scale 4th edition (WAIS-4) Digit Span
时间窗: Baseline
Neuropsychological measure of attention
Trail Making Test B
时间窗: Baseline
Neuropsychological measure of executive functioning
次要结局
未报告次要终点
研究者
Douglas Scharre
Professor, Clinical
Ohio State University