Recruiting

Observational Study

Sponsor:

Douglas Scharre

Code:

NCT03019757

Conditions

Alzheimer's Disease

Lewy Body Dementia

Parkinson's Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

DaTscan

F18-AV-45

FDG-PET

APOE genotype

Polysomnogram

Study Details

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

Study ID

NCT03019757

Start date

Aug 30, 2018

Status verified date

Mar, 2025

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

76 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

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.

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.

Interventions

DaTscan

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

F18-AV-45

A brain scan to to measure the extent of amyloid deposition

FDG-PET

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

APOE genotype

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

Polysomnogram

Overnight sleep study

Clinical Assessment

Clinical assessments include cognitive, behavioral, and motor evaluations

Primary outcome measure

  • Mini Mental State Examination (MMSE-1) [ Time Frame: Baseline ]
  • Wechsler Adult Intelligence Scale 4th edition (WAIS-4) Vocabulary [ Time Frame: Baseline ]
  • Wechsler Adult Intelligence Scale 4th edition (WAIS-4) Digit Span [ Time Frame: Baseline ]
  • Wechsler Adult Intelligence Scale 4th edition (WAIS-4) Block Design [ Time Frame: Baseline ]
  • Wechsler Adult Intelligence Scale 4th edition (WAIS-4) Matrix Reasoning [ Time Frame: Baseline ]
  • Wechsler Adult Intelligence Scale 4th edition (WAIS-4) Reliable Digits (embedded measure) [ Time Frame: Baseline ]
  • Wechsler Memory Scale 3rd ed. (WAIS-3) Spatial Span [ Time Frame: Baseline ]
  • Wechsler Memory Scale 3rd ed. (WAIS-3) Logical Memory 1 & 2 [ Time Frame: Baseline ]
  • Trail Making Test A [ Time Frame: Baseline ]
  • Trail Making Test B [ Time Frame: Baseline ]
  • Boston Naming Test [ Time Frame: Baseline ]
  • Controlled Oral Word Association Test (COWAT)- Animal Naming [ Time Frame: Baseline ]
  • Judgment of Line Orientation Standardized Test [ Time Frame: Baseline ]
  • Brief Visuospatial Memory Test (BVMT) [ Time Frame: Baseline ]
  • California Verbal Learning Test (CVLT-2) [ Time Frame: Baseline ]
  • Wisconsin Card Sorting Task [ Time Frame: Baseline ]
  • California Verbal Learning Test (CVLT-2) Forced Choice (embedded measure) [ Time Frame: Baseline ]
  • Self Administered Gerocognitive Examination- A brief cognitive assessment instrument for mild cognitive impairment and early dementia [ Time Frame: Baseline ]
  • Apolipoprotein E (APOE) Genotyping of a whole blood sample [ Time Frame: Baseline ]
  • Clinical Dementia Rating Scale (CDR) [ Time Frame: Baseline ]
  • The Activities of Daily Living (ADL) Standardized Scale [ Time Frame: Baseline ]
  • Mayo Fluctuations Scale [ Time Frame: Baseline ]
  • Neuropsychiatric Inventory (NPI) [ Time Frame: Baseline ]
  • Beck Depression Inventory 2nd ed. [ Time Frame: Baseline ]
  • The Modified Somatic Perception Questionnaire [ Time Frame: Baseline ]
  • The Epworth Sleepiness Scale [ Time Frame: Baseline ]
  • Mayo Sleep Questionnaire-Informant [ Time Frame: Baseline ]
  • Functional Outcomes of Sleep Questionnaire-10 [ Time Frame: Baseline ]
  • Part III and IV of the Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) [ Time Frame: Baseline ]
  • Berg Balance Scale (BBS) [ Time Frame: Baseline ]
  • Florbetapir (F18-AV-45) positron emission tomography (amyloid PET) [ Time Frame: Baseline ]
  • Single-photon emission computed tomography (SPECT) with the radioligand [123I]FP-CIT [ Time Frame: Baseline ]
  • Positron emission tomography with 2-(18F) fluoro-2-deoxy-d-glucose (FDG-PET) [ Time Frame: Baseline ]
  • Brain MRI [ Time Frame: Baseline ]
  • Polysomnogram [ Time Frame: Baseline ]

Central Contacts and Locations

Central contacts

Jennifer Icenhour

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

Locations

The Ohio State University

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Jennifer Icenhour

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

More Information

Sponsor

Douglas Scharre

Last update posted

Mar 30, 2025

Last verified

Mar, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Douglas Scharre on 2025-03-30.