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NCT Number: NCT03019757

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Ohio State University

Columbus, Ohio, 43210, United States

Location status: Recruiting

Location contact

Jennifer Icenhour

CONTACT

[email protected]

614-293-6882

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

DaTscan

Radiation

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

F18-AV-45

Radiation

A brain scan to to measure the extent of amyloid deposition

FDG-PET

Radiation

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

APOE genotype

Genetic

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

Polysomnogram

Procedure

Overnight sleep study

Clinical Assessment

Behavioral

Clinical assessments include cognitive, behavioral, and motor evaluations

Primary outcomes

  1. Mini Mental State Examination (MMSE-1)

    Time frame: Baseline

    Global neuropsychological measure

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

    Time frame: Baseline

    Neuropsychological measure of premorbid IQ estimate

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

    Time frame: Baseline

    Neuropsychological measure of attention

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

    Time frame: Baseline

    Neuropsychological measure of visuospatial perception/ reasoning

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

    Time frame: Baseline

    Neuropsychological measure of executive functioning

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

    Time frame: Baseline

    Neuropsychological measure of effort

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

    Time frame: Baseline

    Neuropsychological measure of attention

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

    Time frame: Baseline

    Neuropsychological measure of memory

  9. Trail Making Test A

    Time frame: Baseline

    Neuropsychological measure of executive functioning/psychomotor processing speed

  10. Trail Making Test B

    Time frame: Baseline

    Neuropsychological measure of executive functioning

  11. Boston Naming Test

    Time frame: Baseline

    Neuropsychological measure of language

  12. Controlled Oral Word Association Test (COWAT)- Animal Naming

    Time frame: Baseline

    Neuropsychological measure of language/verbal fluency

  13. Judgment of Line Orientation Standardized Test

    Time frame: Baseline

    Neuropsychological measure of visuospatial perception/ reasoning

  14. Brief Visuospatial Memory Test (BVMT)

    Time frame: Baseline

    Neuropsychological measure of memory

  15. California Verbal Learning Test (CVLT-2)

    Time frame: Baseline

    Neuropsychological measure of memory

  16. Wisconsin Card Sorting Task

    Time frame: Baseline

    Neuropsychological measure of executive functioning

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

    Time frame: Baseline

    Neuropsychological measure of effort

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

    Time frame: Baseline

    Global neuropsychological measure

  19. Apolipoprotein E (APOE) Genotyping of a whole blood sample

    Time frame: Baseline

    10 ml of whole blood will be drawn for APOE genotyping

  20. Clinical Dementia Rating Scale (CDR)

    Time frame: Baseline

    Global cognitive and functional measure

  21. The Activities of Daily Living (ADL) Standardized Scale

    Time frame: Baseline

    Functional measure

  22. Mayo Fluctuations Scale

    Time frame: Baseline

    Behavioral measure

  23. Neuropsychiatric Inventory (NPI)

    Time frame: Baseline

    Behavioral measure

  24. Beck Depression Inventory 2nd ed.

    Time frame: Baseline

    Behavioral measure

  25. The Modified Somatic Perception Questionnaire

    Time frame: Baseline

    Behavioral measure

  26. The Epworth Sleepiness Scale

    Time frame: Baseline

    Sleep measure

  27. Mayo Sleep Questionnaire-Informant

    Time frame: Baseline

    Sleep measure

  28. Functional Outcomes of Sleep Questionnaire-10

    Time frame: Baseline

    Sleep measure

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

    Time frame: Baseline

    Gait, Mobility, and Coordination Measure

  30. Berg Balance Scale (BBS)

    Time frame: Baseline

    Gait, Mobility, and Coordination Measure

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

    Time frame: Baseline

    Imaging to determine extent of amyloid deposition

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

    Time frame: Baseline

    Functional imaging of the dopamine transporter

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

    Time frame: Baseline

    Imaging to determine total and regional cerebral glucose metabolism

  34. Brain MRI

    Time frame: Baseline

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

  35. Polysomnogram

    Time frame: 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

Other outcomes

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

    Time frame: Baseline

    Optional outcome measure which will be done to obtain samples of CSF

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

    Time frame: Post mortem

    Optional outcome measure for patients post-mortem to asses for neuropathologic conditions

Study contacts

Contact information is provided by the study sponsor or research team.

Jennifer Icenhour

CONTACT

[email protected]

614-293-6882

Sponsors and collaborators

Lead sponsor

Douglas Scharre

Other

Collaborators

  • Avid Radiopharmaceuticals
  • Mangurian Foundation

Registry information

Important dates

Study start
2018
Primary completion
2026
Study completion
2026
First posted
Jan 13, 2017
Registry last updated
Mar 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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