What this study is
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.
What's being tested
- DaTscan
Intervention · RADIATION
A functional imaging of the dopamine transporter using the radioligand [123I]FP-CIT
- F18-AV-45
Intervention · RADIATION
A brain scan to to measure the extent of amyloid deposition
- FDG-PET
Intervention · RADIATION
a brain scan measuring total and regional cerebral glucose metabolism wtih positron emission tomographs with 2-(18F)
- APOE genotype
Intervention · GENETIC
10 ml of whole blood will be drawn and shipped to Athena Diagnostics for genetic testing.
- Polysomnogram
Intervention · PROCEDURE
Overnight sleep study
- Clinical Assessment
Intervention · BEHAVIORAL
Clinical assessments include cognitive, behavioral, and motor evaluations
Study details
- Sponsor
- Douglas Scharre
- Conditions
- Alzheimer's Disease · Lewy Body Dementia · Parkinson's Disease
- Enrolling
- 76 people
- Starts
- 2018-08-30
- Est. completion
- 2027-12-31
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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.
You can't join if
- 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openThe Ohio State University
Columbus, Ohio, United States
- Jennifer Icenhour · Contact614-293-6882jennifer.icenhour@osumc.edu
Recruiting
Study team
Sponsor
Douglas Scharre
Study ID 2014H0415
Principal investigator
Douglas W Scharre, MD
Ohio State University
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.