Health TrialsbyHealthPanel

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

ConditionsAlzheimer's DiseaseLewy Body DementiaParkinson's Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorDouglas Scharre

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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).

Trial population

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

Trial design

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

  • 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/Surgery

    Overnight sleep study

  • Clinical Assessment

    Behavioral

    Clinical assessments include cognitive, behavioral, and motor evaluations

Treatment groups

76 Participants
are divided into 3 treatment groups
Group A: Alzheimer's disease6 interventions
Group B: Lewy Body dementia6 interventions
Group C: Parkinson's disease6 interventions

Trial outcomes

Primary outcomes

1

Mini Mental State Examination (MMSE-1)

Global neuropsychological measure

Time frame
Baseline
2

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

Neuropsychological measure of premorbid IQ estimate

Time frame
Baseline
3

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

Neuropsychological measure of attention

Time frame
Baseline
4

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

Neuropsychological measure of visuospatial perception/ reasoning

Time frame
Baseline

Secondary outcomes

Other outcomes

1

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

Time frame
Baseline
2

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

Time frame
Post mortem

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Douglas Scharre

Lead sponsor

Ohio State University

Sponsor institution

Avid Radiopharmaceuticals

Collaborator

Mangurian Foundation

Collaborator

Source ClinicalTrials.gov
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