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

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.

Study Overview

• Status: Recruiting
• Conditions: Parkinson's Disease; Alzheimer's Disease; Lewy Body Dementia
• Intervention / Treatment: Radiation: DaTscan; Radiation: F18-AV-45; Radiation: FDG-PET; Genetic: APOE genotype; Procedure: Polysomnogram; Behavioral: Clinical Assessment

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.

• Study Type: Observational
• Enrollment (Estimated): 76

Contacts and Locations

• Study Contact: Name: Jennifer Icenhour; Phone Number: 614-293-6882; Email: jennifer.icenhour@osumc.edu

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Recruiting
      • The Ohio State University
      • Contact: Jennifer Icenhour; Phone Number: 614-293-6882; Email: jennifer.icenhour@osumc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Subjects must have a clinical diagnosis of either Alzheimer's disease, Lewy Body Dementia, or Parkinson's disease.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Alzheimer's disease; 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.	Radiation: DaTscan; A functional imaging of the dopamine transporter using the radioligand [123I]FP-CIT; Radiation: F18-AV-45; A brain scan to to measure the extent of amyloid deposition; Radiation: FDG-PET; a brain scan measuring total and regional cerebral glucose metabolism wtih positron emission tomographs with 2-(18F); Genetic: APOE genotype; 10 ml of whole blood will be drawn and shipped to Athena Diagnostics for genetic testing.; Procedure: Polysomnogram; Overnight sleep study; Behavioral: Clinical Assessment; Clinical assessments include cognitive, behavioral, and motor evaluations
Lewy Body dementia; 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.	Radiation: DaTscan; A functional imaging of the dopamine transporter using the radioligand [123I]FP-CIT; Radiation: F18-AV-45; A brain scan to to measure the extent of amyloid deposition; Radiation: FDG-PET; a brain scan measuring total and regional cerebral glucose metabolism wtih positron emission tomographs with 2-(18F); Genetic: APOE genotype; 10 ml of whole blood will be drawn and shipped to Athena Diagnostics for genetic testing.; Procedure: Polysomnogram; Overnight sleep study; Behavioral: Clinical Assessment; Clinical assessments include cognitive, behavioral, and motor evaluations
Parkinson's disease; 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.	Radiation: DaTscan; A functional imaging of the dopamine transporter using the radioligand [123I]FP-CIT; Radiation: F18-AV-45; A brain scan to to measure the extent of amyloid deposition; Radiation: FDG-PET; a brain scan measuring total and regional cerebral glucose metabolism wtih positron emission tomographs with 2-(18F); Genetic: APOE genotype; 10 ml of whole blood will be drawn and shipped to Athena Diagnostics for genetic testing.; Procedure: Polysomnogram; Overnight sleep study; Behavioral: Clinical Assessment; Clinical assessments include cognitive, behavioral, and motor evaluations

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mini Mental State Examination (MMSE-1)	Global neuropsychological measure	Baseline
Wechsler Adult Intelligence Scale 4th edition (WAIS-4) Vocabulary	Neuropsychological measure of premorbid IQ estimate	Baseline
Wechsler Adult Intelligence Scale 4th edition (WAIS-4) Digit Span	Neuropsychological measure of attention	Baseline
Wechsler Adult Intelligence Scale 4th edition (WAIS-4) Block Design	Neuropsychological measure of visuospatial perception/ reasoning	Baseline
Wechsler Adult Intelligence Scale 4th edition (WAIS-4) Matrix Reasoning	Neuropsychological measure of executive functioning	Baseline
Wechsler Adult Intelligence Scale 4th edition (WAIS-4) Reliable Digits (embedded measure)	Neuropsychological measure of effort	Baseline
Wechsler Memory Scale 3rd ed. (WAIS-3) Spatial Span	Neuropsychological measure of attention	Baseline
Wechsler Memory Scale 3rd ed. (WAIS-3) Logical Memory 1 & 2	Neuropsychological measure of memory	Baseline
Trail Making Test A	Neuropsychological measure of executive functioning/psychomotor processing speed	Baseline
Trail Making Test B	Neuropsychological measure of executive functioning	Baseline
Boston Naming Test	Neuropsychological measure of language	Baseline
Controlled Oral Word Association Test (COWAT)- Animal Naming	Neuropsychological measure of language/verbal fluency	Baseline
Judgment of Line Orientation Standardized Test	Neuropsychological measure of visuospatial perception/ reasoning	Baseline
Brief Visuospatial Memory Test (BVMT)	Neuropsychological measure of memory	Baseline
California Verbal Learning Test (CVLT-2)	Neuropsychological measure of memory	Baseline
Wisconsin Card Sorting Task	Neuropsychological measure of executive functioning	Baseline
California Verbal Learning Test (CVLT-2) Forced Choice (embedded measure)	Neuropsychological measure of effort	Baseline
Self Administered Gerocognitive Examination- A brief cognitive assessment instrument for mild cognitive impairment and early dementia	Global neuropsychological measure	Baseline
Apolipoprotein E (APOE) Genotyping of a whole blood sample	10 ml of whole blood will be drawn for APOE genotyping	Baseline
Clinical Dementia Rating Scale (CDR)	Global cognitive and functional measure	Baseline
The Activities of Daily Living (ADL) Standardized Scale	Functional measure	Baseline
Mayo Fluctuations Scale	Behavioral measure	Baseline
Neuropsychiatric Inventory (NPI)	Behavioral measure	Baseline
Beck Depression Inventory 2nd ed.	Behavioral measure	Baseline
The Modified Somatic Perception Questionnaire	Behavioral measure	Baseline
The Epworth Sleepiness Scale	Sleep measure	Baseline
Mayo Sleep Questionnaire-Informant	Sleep measure	Baseline
Functional Outcomes of Sleep Questionnaire-10	Sleep measure	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	Baseline
Berg Balance Scale (BBS)	Gait, Mobility, and Coordination Measure	Baseline
Florbetapir (F18-AV-45) positron emission tomography (amyloid PET)	Imaging to determine extent of amyloid deposition	Baseline
Single-photon emission computed tomography (SPECT) with the radioligand [123I]FP-CIT	Functional imaging of the dopamine transporter	Baseline
Positron emission tomography with 2-(18F) fluoro-2-deoxy-d-glucose (FDG-PET)	Imaging to determine total and regional cerebral glucose metabolism	Baseline
Brain MRI	Imaging including a resting state functional MRI, diffusion tensor imaging, and anatomic imaging	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	Baseline

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lumbar Puncture to obtain cerebrospinal fluid (CSF) that will be stored for future potential evaluation of biomarkers	Optional outcome measure which will be done to obtain samples of CSF	Baseline
Post-mortem brain donation to The Ohio State University Neurodegenerative Disease Brain Tissue Repository, for clinicopathological correlations	Optional outcome measure for patients post-mortem to asses for neuropathologic conditions	Post mortem

Collaborators and Investigators

• Sponsor: Douglas Scharre
• Collaborators: Avid Radiopharmaceuticals; Mangurian Foundation
• Investigators: Principal Investigator: Douglas W Scharre, MD, Ohio State University

Study record dates

Study Major Dates

• Study Start (Actual): August 30, 2018
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: September 3, 2015
• First Submitted That Met QC Criteria: January 10, 2017
• First Posted (Estimated): January 13, 2017

Study Record Updates

• Last Update Posted (Actual): October 26, 2023
• Last Update Submitted That Met QC Criteria: October 24, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Tauopathies; Parkinson Disease; Dementia; Alzheimer Disease; Lewy Body Disease
• Other Study ID Numbers: 2014H0415