Distinguishing Between Alzheimer's Disease, Lewy Body Dementia, and Parkinson's Disease
- Conditions
- Alzheimer's DiseaseLewy Body DementiaParkinson's Disease
- Interventions
- Radiation: DaTscanRadiation: F18-AV-45Radiation: FDG-PETGenetic: APOE genotypeProcedure: PolysomnogramBehavioral: Clinical Assessment
- Registration Number
- NCT03019757
- Lead Sponsor
- Douglas Scharre
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 76
- 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 10.
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Alzheimer's disease FDG-PET Individuals with a clinical diagnosis of Alzheimer's disease will undergo the interventions including DaTscan, F18-AV-45, FDG-PET, APOE genotype, Polysomnogram, and Clinical Assessment. Lewy Body dementia F18-AV-45 Individuals with a clinical diagnosis of Lewy Body Dementia will undergo the interventions including DaTscan, F18-AV-45, FDG-PET, APOE genotype, Polysomnogram, and Clinical Assessment. Parkinson's disease APOE genotype Individuals with a clinical diagnosis of Parkinson's disease will undergo the interventions including DaTscan, F18-AV-45, FDG-PET, APOE genotype, Polysomnogram, and Clinical Assessment. Parkinson's disease Clinical Assessment Individuals with a clinical diagnosis of Parkinson's disease will undergo the interventions including DaTscan, F18-AV-45, FDG-PET, APOE genotype, Polysomnogram, and Clinical Assessment. Lewy Body dementia FDG-PET Individuals with a clinical diagnosis of Lewy Body Dementia will undergo the interventions including DaTscan, F18-AV-45, FDG-PET, APOE genotype, Polysomnogram, and Clinical Assessment. Lewy Body dementia APOE genotype Individuals with a clinical diagnosis of Lewy Body Dementia will undergo the interventions including DaTscan, F18-AV-45, FDG-PET, APOE genotype, Polysomnogram, and Clinical Assessment. Alzheimer's disease APOE genotype Individuals with a clinical diagnosis of Alzheimer's disease will undergo the interventions including DaTscan, F18-AV-45, FDG-PET, APOE genotype, Polysomnogram, and Clinical Assessment. Alzheimer's disease DaTscan Individuals with a clinical diagnosis of Alzheimer's disease will undergo the interventions including DaTscan, F18-AV-45, FDG-PET, APOE genotype, Polysomnogram, and Clinical Assessment. Alzheimer's disease Polysomnogram Individuals with a clinical diagnosis of Alzheimer's disease will undergo the interventions including DaTscan, F18-AV-45, FDG-PET, APOE genotype, Polysomnogram, and Clinical Assessment. Alzheimer's disease Clinical Assessment Individuals with a clinical diagnosis of Alzheimer's disease will undergo the interventions including DaTscan, F18-AV-45, FDG-PET, APOE genotype, Polysomnogram, and Clinical Assessment. Lewy Body dementia DaTscan Individuals with a clinical diagnosis of Lewy Body Dementia will undergo the interventions including DaTscan, F18-AV-45, FDG-PET, APOE genotype, Polysomnogram, and Clinical Assessment. Lewy Body dementia Clinical Assessment Individuals with a clinical diagnosis of Lewy Body Dementia will undergo the interventions including DaTscan, F18-AV-45, FDG-PET, APOE genotype, Polysomnogram, and Clinical Assessment. Parkinson's disease DaTscan Individuals with a clinical diagnosis of Parkinson's disease will undergo the interventions including DaTscan, F18-AV-45, FDG-PET, APOE genotype, Polysomnogram, and Clinical Assessment. Parkinson's disease F18-AV-45 Individuals with a clinical diagnosis of Parkinson's disease will undergo the interventions including DaTscan, F18-AV-45, FDG-PET, APOE genotype, Polysomnogram, and Clinical Assessment. Parkinson's disease FDG-PET Individuals with a clinical diagnosis of Parkinson's disease will undergo the interventions including DaTscan, F18-AV-45, FDG-PET, APOE genotype, Polysomnogram, and Clinical Assessment. Parkinson's disease Polysomnogram Individuals with a clinical diagnosis of Parkinson's disease will undergo the interventions including DaTscan, F18-AV-45, FDG-PET, APOE genotype, Polysomnogram, and Clinical Assessment. Alzheimer's disease F18-AV-45 Individuals with a clinical diagnosis of Alzheimer's disease will undergo the interventions including DaTscan, F18-AV-45, FDG-PET, APOE genotype, Polysomnogram, and Clinical Assessment. Lewy Body dementia Polysomnogram Individuals with a clinical diagnosis of Lewy Body Dementia will undergo the interventions including DaTscan, F18-AV-45, FDG-PET, APOE genotype, Polysomnogram, and Clinical Assessment.
- Primary Outcome Measures
Name Time Method Brain MRI Baseline Imaging including a resting state functional MRI, diffusion tensor imaging, and anatomic imaging
The Activities of Daily Living (ADL) Standardized Scale Baseline Functional measure
Mayo Fluctuations Scale Baseline Behavioral measure
Functional Outcomes of Sleep Questionnaire-10 Baseline Sleep measure
Berg Balance Scale (BBS) Baseline Gait, Mobility, and Coordination Measure
Wechsler Memory Scale 3rd ed. (WAIS-3) Logical Memory 1 & 2 Baseline Neuropsychological measure of memory
Boston Naming Test Baseline Neuropsychological measure of language
Wisconsin Card Sorting Task Baseline Neuropsychological measure of executive functioning
Clinical Dementia Rating Scale (CDR) Baseline Global cognitive and functional measure
Mayo Sleep Questionnaire-Informant Baseline Sleep measure
Apolipoprotein E (APOE) Genotyping of a whole blood sample Baseline 10 ml of whole blood will be drawn for APOE genotyping
Wechsler Adult Intelligence Scale 4th edition (WAIS-4) Block Design Baseline Neuropsychological measure of visuospatial perception/ reasoning
Wechsler Adult Intelligence Scale 4th edition (WAIS-4) Matrix Reasoning Baseline Neuropsychological measure of executive functioning
Wechsler Adult Intelligence Scale 4th edition (WAIS-4) Reliable Digits (embedded measure) Baseline Neuropsychological measure of effort
Judgment of Line Orientation Standardized Test Baseline Neuropsychological measure of visuospatial perception/ reasoning
Brief Visuospatial Memory Test (BVMT) Baseline Neuropsychological measure of memory
California Verbal Learning Test (CVLT-2) Baseline Neuropsychological measure of memory
Self Administered Gerocognitive Examination- A brief cognitive assessment instrument for mild cognitive impairment and early dementia Baseline Global neuropsychological measure
Beck Depression Inventory 2nd ed. Baseline Behavioral measure
The Modified Somatic Perception Questionnaire Baseline Behavioral measure
The Epworth Sleepiness Scale Baseline Sleep measure
Florbetapir (F18-AV-45) positron emission tomography (amyloid PET) Baseline Imaging to determine extent of amyloid deposition
Single-photon emission computed tomography (SPECT) with the radioligand [123I]FP-CIT Baseline Functional imaging of the dopamine transporter
Positron emission tomography with 2-(18F) fluoro-2-deoxy-d-glucose (FDG-PET) Baseline Imaging to determine total and regional cerebral glucose metabolism
Wechsler Memory Scale 3rd ed. (WAIS-3) Spatial Span Baseline Neuropsychological measure of attention
Trail Making Test A Baseline Neuropsychological measure of executive functioning/psychomotor processing speed
Controlled Oral Word Association Test (COWAT)- Animal Naming Baseline Neuropsychological measure of language/verbal fluency
California Verbal Learning Test (CVLT-2) Forced Choice (embedded measure) Baseline Neuropsychological measure of effort
Neuropsychiatric Inventory (NPI) Baseline Behavioral measure
Part III and IV of the Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Baseline Gait, Mobility, and Coordination Measure
Polysomnogram 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) Baseline Global neuropsychological measure
Wechsler Adult Intelligence Scale 4th edition (WAIS-4) Vocabulary Baseline Neuropsychological measure of premorbid IQ estimate
Wechsler Adult Intelligence Scale 4th edition (WAIS-4) Digit Span Baseline Neuropsychological measure of attention
Trail Making Test B Baseline Neuropsychological measure of executive functioning
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
The Ohio State University
🇺🇸Columbus, Ohio, United States