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

NCT03019757 | Recruiting

• 1 other identifier: 2014H0415
• Study Type: observational
• Target: 76
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer's Disease; Lewy Body Dementia; Parkinson's Disease

Outcome Measures

Primary Outcomes (35)

• 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 Outcomes (2)

• Lumbar Puncture to obtain cerebrospinal fluid (CSF) that will be stored for future potential evaluation of biomarkers

  Baseline

• Post-mortem brain donation to The Ohio State University Neurodegenerative Disease Brain Tissue Repository, for clinicopathological correlations

  Post mortem

Study Arms (3)

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; Radiation: F18-AV-45; Radiation: FDG-PET; Genetic: APOE genotype; Procedure: Polysomnogram; Behavioral: Clinical Assessment

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; Radiation: F18-AV-45; Radiation: FDG-PET; Genetic: APOE genotype; Procedure: Polysomnogram; Behavioral: Clinical Assessment

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; Radiation: F18-AV-45; Radiation: FDG-PET; Genetic: APOE genotype; Procedure: Polysomnogram; Behavioral: Clinical Assessment

Interventions

DaTscan RADIATION

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

Alzheimer's disease; Lewy Body dementia; Parkinson's disease

F18-AV-45 RADIATION

A brain scan to to measure the extent of amyloid deposition

Alzheimer's disease; Lewy Body dementia; Parkinson's disease

FDG-PET RADIATION

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

Alzheimer's disease; Lewy Body dementia; Parkinson's disease

APOE genotype GENETIC

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

Alzheimer's disease; Lewy Body dementia; Parkinson's disease

Polysomnogram PROCEDURE

Overnight sleep study

Alzheimer's disease; Lewy Body dementia; Parkinson's disease

Clinical Assessment BEHAVIORAL

Clinical assessments include cognitive, behavioral, and motor evaluations

Alzheimer's disease; Lewy Body dementia; Parkinson's disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Douglas Scharre: lead
• Avid Radiopharmaceuticals: collaborator
• Mangurian Foundation: collaborator

Study Sites (1)

The Ohio State University

Columbus, Ohio, 43210, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Participants will have the option to participate in a lumbar puncture sub-study as well as a brain donation program. These samples will be retained in the Buckeye Biospecimen Repository or the Buckeye Brain Bank, respectively.

MeSH Terms

Conditions

Alzheimer Disease; Lewy Body Disease; Parkinson Disease

Interventions

ioflupane; florbetapir

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies

Study Officials

• Douglas W Scharre, MD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jennifer Icenhour

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, Clinical

Study Record Dates

• First Submitted: September 3, 2015
• First Posted: January 13, 2017
• Study Start: August 30, 2018
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 30, 2025

Record last verified: 2025-03

Locations

US (1)