Distinguishing Between Alzheimer's Disease, Lewy Body Dementia, and Parkinson's Disease

N/ARecruitingNCT03019757

Douglas Scharre76 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Alzheimer's Disease Lewy Body Dementia Parkinson's Disease

Interventions

DaTscanRADIATION

A functional imaging of the dopamine transporter using the radioligand \[123I\]FP-CIT

F18-AV-45RADIATION

A brain scan to to measure the extent of amyloid deposition

FDG-PETRADIATION

a brain scan measuring total and regional cerebral glucose metabolism wtih positron emission tomographs with 2-(18F)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Locations (1)

The Ohio State University

Columbus, Ohio, United States

RECRUITING

Outcomes

Primary Outcomes

Mini Mental State Examination (MMSE-1)

Global neuropsychological measure

Time frame: Baseline

Wechsler Adult Intelligence Scale 4th edition (WAIS-4) Vocabulary

Neuropsychological measure of premorbid IQ estimate

Time frame: Baseline

Wechsler Adult Intelligence Scale 4th edition (WAIS-4) Digit Span

Neuropsychological measure of attention

Time frame: Baseline

Wechsler Adult Intelligence Scale 4th edition (WAIS-4) Block Design

Neuropsychological measure of visuospatial perception/ reasoning

Time frame: Baseline

Wechsler Adult Intelligence Scale 4th edition (WAIS-4) Matrix Reasoning

Neuropsychological measure of executive functioning

Time frame: Baseline

Wechsler Adult Intelligence Scale 4th edition (WAIS-4) Reliable Digits (embedded measure)

Neuropsychological measure of effort

Time frame: Baseline

Wechsler Memory Scale 3rd ed. (WAIS-3) Spatial Span

Neuropsychological measure of attention

Time frame: Baseline

Wechsler Memory Scale 3rd ed. (WAIS-3) Logical Memory 1 & 2

Neuropsychological measure of memory

Time frame: Baseline

Trail Making Test A

Neuropsychological measure of executive functioning/psychomotor processing speed

Central Contacts

Jennifer Icenhour

CONTACT

614-293-6882 jennifer.icenhour@osumc.edu

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

10 ml of whole blood will be drawn and shipped to Athena Diagnostics for genetic testing.

PolysomnogramPROCEDURE

Overnight sleep study

Clinical AssessmentBEHAVIORAL

Clinical assessments include cognitive, behavioral, and motor evaluations

Time frame: Baseline

Trail Making Test B

Neuropsychological measure of executive functioning

Time frame: Baseline

Boston Naming Test

Neuropsychological measure of language

Time frame: Baseline

Controlled Oral Word Association Test (COWAT)- Animal Naming

Neuropsychological measure of language/verbal fluency

Time frame: Baseline

Judgment of Line Orientation Standardized Test

Neuropsychological measure of visuospatial perception/ reasoning

Time frame: Baseline

Brief Visuospatial Memory Test (BVMT)

Neuropsychological measure of memory

Time frame: Baseline

California Verbal Learning Test (CVLT-2)

Neuropsychological measure of memory

Time frame: Baseline

Wisconsin Card Sorting Task

Neuropsychological measure of executive functioning

Time frame: Baseline

California Verbal Learning Test (CVLT-2) Forced Choice (embedded measure)

Neuropsychological measure of effort

Time frame: Baseline

Self Administered Gerocognitive Examination- A brief cognitive assessment instrument for mild cognitive impairment and early dementia

Global neuropsychological measure

Time frame: Baseline

Apolipoprotein E (APOE) Genotyping of a whole blood sample

10 ml of whole blood will be drawn for APOE genotyping

Time frame: Baseline

Clinical Dementia Rating Scale (CDR)

Global cognitive and functional measure

Time frame: Baseline

The Activities of Daily Living (ADL) Standardized Scale

Functional measure

Time frame: Baseline

Mayo Fluctuations Scale

Behavioral measure

Time frame: Baseline

Neuropsychiatric Inventory (NPI)

Behavioral measure

Time frame: Baseline

Beck Depression Inventory 2nd ed.

Behavioral measure

Time frame: Baseline

The Modified Somatic Perception Questionnaire

Behavioral measure

Time frame: Baseline

The Epworth Sleepiness Scale

Sleep measure

Time frame: Baseline

Mayo Sleep Questionnaire-Informant

Sleep measure

Time frame: Baseline

Functional Outcomes of Sleep Questionnaire-10

Sleep measure

Time frame: Baseline

Part III and IV of the Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS)

Gait, Mobility, and Coordination Measure

Time frame: Baseline

Berg Balance Scale (BBS)

Gait, Mobility, and Coordination Measure

Time frame: Baseline

Florbetapir (F18-AV-45) positron emission tomography (amyloid PET)

Imaging to determine extent of amyloid deposition

Time frame: Baseline

Single-photon emission computed tomography (SPECT) with the radioligand [123I]FP-CIT

Functional imaging of the dopamine transporter

Time frame: Baseline

Positron emission tomography with 2-(18F) fluoro-2-deoxy-d-glucose (FDG-PET)

Imaging to determine total and regional cerebral glucose metabolism

Time frame: Baseline

Brain MRI

Imaging including a resting state functional MRI, diffusion tensor imaging, and anatomic imaging

Time frame: Baseline

Polysomnogram

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

Time frame: Baseline