Distinguishing Between Alzheimer's Disease, Lewy Body Dementia, and Parkinson's Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: DaTscan, F18-AV-45, FDG-PET, APOE genotype.
- Who it may be relevant to
- Registry conditions: Alzheimer's Disease, Lewy Body Dementia, Parkinson's Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
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.
Interventions
- Radiation DaTscan
A functional imaging of the dopamine transporter using the radioligand \[123I\]FP-CIT - Radiation F18-AV-45
A brain scan to to measure the extent of amyloid deposition - Radiation FDG-PET
a brain scan measuring total and regional cerebral glucose metabolism wtih positron emission tomographs with 2-(18F) - Genetic APOE genotype
10 ml of whole blood will be drawn and shipped to Athena Diagnostics for genetic testing. - Procedure Polysomnogram
Overnight sleep study - Behavioral Clinical Assessment
Clinical assessments include cognitive, behavioral, and motor evaluations
Primary outcome measures
- Mini Mental State Examination (MMSE-1) [Time frame: Baseline]
- Wechsler Adult Intelligence Scale 4th edition (WAIS-4) Vocabulary [Time frame: Baseline]
- Wechsler Adult Intelligence Scale 4th edition (WAIS-4) Digit Span [Time frame: Baseline]
- Wechsler Adult Intelligence Scale 4th edition (WAIS-4) Block Design [Time frame: Baseline]
- Wechsler Adult Intelligence Scale 4th edition (WAIS-4) Matrix Reasoning [Time frame: Baseline]
- Wechsler Adult Intelligence Scale 4th edition (WAIS-4) Reliable Digits (embedded measure) [Time frame: Baseline]
- Wechsler Memory Scale 3rd ed. (WAIS-3) Spatial Span [Time frame: Baseline]
- Wechsler Memory Scale 3rd ed. (WAIS-3) Logical Memory 1 & 2 [Time frame: Baseline]
- Trail Making Test A [Time frame: Baseline]
- Trail Making Test B [Time frame: Baseline]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- The Ohio State University — Columbus
Identifiers
NCT: NCT03019757 · 2014H0415