Distinguishing Between Alzheimer's Disease, Lewy Body Dementia, and Parkinson's Disease
NCT ID: NCT03019757
Last Updated: 2025-03-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
76 participants
OBSERVATIONAL
2018-08-30
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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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.
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
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.
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
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.
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Avid Radiopharmaceuticals
INDUSTRY
Mangurian Foundation
UNKNOWN
Douglas Scharre
OTHER
Responsible Party
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Douglas Scharre
Professor, Clinical
Principal Investigators
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Douglas W Scharre, MD
Role: PRINCIPAL_INVESTIGATOR
Ohio State University
Locations
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The Ohio State University
Columbus, Ohio, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2014H0415
Identifier Type: -
Identifier Source: org_study_id
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