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Understanding Alzheimer's, Lewy Body, and Parkinson's Diseases

This observational study aims to better understand the differences between Alzheimer's disease, Lewy Body dementia, and Parkinson's disease. Researchers will use various tests, including brain scans like DaTscan, F18-AV-45 (to measure amyloid deposits), and FDG-PET (to measure brain activity). They will also collect blood for APOE genetic testing and conduct overnight sleep studies (polysomnograms). The study is looking for about 76 participants, aged 18 and older, who meet standard clinical criteria for these conditions and have enough cognitive ability to complete study procedures (a Mini Mental State Examination score of 10 or higher). The study will measure cognitive abilities using tests like the Mini Mental State Examination and Wechsler Adult Intelligence Scale at the beginning of the study.

Study design
This is an observational study with no specified phase, aiming to enroll about 76 participants. It is designed to characterize clinical, neuropsychological, sleep, and brain imaging findings.
What's involved
You would undergo a clinical evaluation, physical and neurological exams, blood collection for genetic testing, neuropsychological tests, an overnight sleep study, and various brain scans (MRI, DaTscan, FDG-PET, Amyvid PET). Your study partner would also be interviewed.
Compensation
Not stated in the trial record.
Follow-up
Cognitive abilities will be measured at baseline (the start of the study).

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NCT03019757

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

Recruiting
Not specifiedAges 18+Observational
Douglas Scharre
~76 participants
Updated 2025-03-30 on ClinicalTrials.gov
What's tested:DaTscanF18-AV-45FDG-PETAPOE genotypePolysomnogramClinical Assessment

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Mini Mental State Examination (MMSE-1)
Measured over Baseline
+34 more outcomes measured

Conditions

Alzheimer's Disease
Lewy Body Dementia
Parkinson's Disease

Explore related trials

Alzheimer's DiseaseLewy Body DementiaParkinson Disease

Where it's being run

1 sites across 1 states
Ohio1

Study leadership

  • Douglas W Scharre, MD · PRINCIPAL_INVESTIGATOR · Ohio State University

Who to contact

Jennifer Icenhour
[email protected]
614-293-6882
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Mini Mental State Examination (MMSE-1)Baseline

    Global neuropsychological measure

  • Wechsler Adult Intelligence Scale 4th edition (WAIS-4) VocabularyBaseline

    Neuropsychological measure of premorbid IQ estimate

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

    Neuropsychological measure of attention

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

    Neuropsychological measure of visuospatial perception/ reasoning

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

    Neuropsychological measure of executive functioning

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

    Neuropsychological measure of effort

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

    Neuropsychological measure of attention

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

    Neuropsychological measure of memory

  • Trail Making Test ABaseline

    Neuropsychological measure of executive functioning/psychomotor processing speed

  • Trail Making Test BBaseline

    Neuropsychological measure of executive functioning

  • Boston Naming TestBaseline

    Neuropsychological measure of language

  • Controlled Oral Word Association Test (COWAT)- Animal NamingBaseline

    Neuropsychological measure of language/verbal fluency

  • Judgment of Line Orientation Standardized TestBaseline

    Neuropsychological measure of visuospatial perception/ reasoning

  • Brief Visuospatial Memory Test (BVMT)Baseline

    Neuropsychological measure of memory

  • California Verbal Learning Test (CVLT-2)Baseline

    Neuropsychological measure of memory

  • Wisconsin Card Sorting TaskBaseline

    Neuropsychological measure of executive functioning

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

    Neuropsychological measure of effort

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

    Global neuropsychological measure

  • Apolipoprotein E (APOE) Genotyping of a whole blood sampleBaseline

    10 ml of whole blood will be drawn for APOE genotyping

  • Clinical Dementia Rating Scale (CDR)Baseline

    Global cognitive and functional measure

  • The Activities of Daily Living (ADL) Standardized ScaleBaseline

    Functional measure

  • Mayo Fluctuations ScaleBaseline

    Behavioral measure

  • Neuropsychiatric Inventory (NPI)Baseline

    Behavioral measure

  • Beck Depression Inventory 2nd ed.Baseline

    Behavioral measure

  • The Modified Somatic Perception QuestionnaireBaseline

    Behavioral measure

  • The Epworth Sleepiness ScaleBaseline

    Sleep measure

  • Mayo Sleep Questionnaire-InformantBaseline

    Sleep measure

  • Functional Outcomes of Sleep Questionnaire-10Baseline

    Sleep measure

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

    Gait, Mobility, and Coordination Measure

  • Berg Balance Scale (BBS)Baseline

    Gait, Mobility, and Coordination Measure

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

    Imaging to determine extent of amyloid deposition

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

    Functional imaging of the dopamine transporter

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

    Imaging to determine total and regional cerebral glucose metabolism

  • Brain MRIBaseline

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

  • PolysomnogramBaseline

    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