The Ohio State University
Columbus, Ohio, 43210, United States
Location status: Recruiting
NCT Number: NCT03019757
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Columbus, Ohio, 43210, United States
Location status: Recruiting
The study will use structural and functional MRIs, daTscans, fluorodeoxyglucose (FDG) PET scans, Amyvid PET scans, polysomnographs, neuropsychological testing, cerebrospinal fluid in willing participants to distinguish between a diagnosis of Alzheimer's disease, Lewy Body dementia, and Parkinson's Disease. All subjects will have a clinical evaluation, physical examination including vital signs and orthostatic blood pressures and pulses, neurological examination including UPDRS evaluation, genetic blood sample collection, neuropsychological testing, polysomnogram, and neuroimaging. The study partner will also be interviewed for completion of all of the behavioral and functional measures.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A functional imaging of the dopamine transporter using the radioligand [123I]FP-CIT
A brain scan to to measure the extent of amyloid deposition
a brain scan measuring total and regional cerebral glucose metabolism wtih positron emission tomographs with 2-(18F)
10 ml of whole blood will be drawn and shipped to Athena Diagnostics for genetic testing.
Overnight sleep study
Clinical assessments include cognitive, behavioral, and motor evaluations
Time frame: Baseline
Global neuropsychological measure
Time frame: Baseline
Neuropsychological measure of premorbid IQ estimate
Time frame: Baseline
Neuropsychological measure of attention
Time frame: Baseline
Neuropsychological measure of visuospatial perception/ reasoning
Time frame: Baseline
Neuropsychological measure of executive functioning
Time frame: Baseline
Neuropsychological measure of effort
Time frame: Baseline
Neuropsychological measure of attention
Time frame: Baseline
Neuropsychological measure of memory
Time frame: Baseline
Neuropsychological measure of executive functioning/psychomotor processing speed
Time frame: Baseline
Neuropsychological measure of executive functioning
Time frame: Baseline
Neuropsychological measure of language
Time frame: Baseline
Neuropsychological measure of language/verbal fluency
Time frame: Baseline
Neuropsychological measure of visuospatial perception/ reasoning
Time frame: Baseline
Neuropsychological measure of memory
Time frame: Baseline
Neuropsychological measure of memory
Time frame: Baseline
Neuropsychological measure of executive functioning
Time frame: Baseline
Neuropsychological measure of effort
Time frame: Baseline
Global neuropsychological measure
Time frame: Baseline
10 ml of whole blood will be drawn for APOE genotyping
Time frame: Baseline
Global cognitive and functional measure
Time frame: Baseline
Functional measure
Time frame: Baseline
Behavioral measure
Time frame: Baseline
Behavioral measure
Time frame: Baseline
Behavioral measure
Time frame: Baseline
Behavioral measure
Time frame: Baseline
Sleep measure
Time frame: Baseline
Sleep measure
Time frame: Baseline
Sleep measure
Time frame: Baseline
Gait, Mobility, and Coordination Measure
Time frame: Baseline
Gait, Mobility, and Coordination Measure
Time frame: Baseline
Imaging to determine extent of amyloid deposition
Time frame: Baseline
Functional imaging of the dopamine transporter
Time frame: Baseline
Imaging to determine total and regional cerebral glucose metabolism
Time frame: Baseline
Imaging including a resting state functional MRI, diffusion tensor imaging, and anatomic imaging
Time frame: Baseline
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
Time frame: Baseline
Optional outcome measure which will be done to obtain samples of CSF
Time frame: Post mortem
Optional outcome measure for patients post-mortem to asses for neuropathologic conditions
Contact information is provided by the study sponsor or research team.
Douglas Scharre
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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