RecruitingNCT03019757

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


Sponsor

Douglas Scharre

Enrollment

76 participants

Start Date

Aug 30, 2018

Study Type

OBSERVATIONAL

Conditions

Summary

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

Min Age: 18 Years

Inclusion Criteria5

  • 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 Criteria7

  • 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.

Interventions

RADIATIONDaTscan

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

RADIATIONF18-AV-45

A brain scan to to measure the extent of amyloid deposition

RADIATIONFDG-PET

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

GENETICAPOE genotype

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

PROCEDUREPolysomnogram

Overnight sleep study

BEHAVIORALClinical Assessment

Clinical assessments include cognitive, behavioral, and motor evaluations


Locations(1)

The Ohio State University

Columbus, Ohio, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT03019757


Related Trials