Alzheimer's DiseaseNCT03019757
Distinguishing Between Alzheimer's Disease, Lewy Body Dementia, and Parkinson's Disease
An observational study of Alzheimer's Disease and Lewy Body Dementia, run by Douglas Scharre at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alzheimer's Disease, Lewy Body Dementia, Parkinson's Disease
- What is being tested?
- DaTscan, F18-AV-45 and FDG-PET
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- How many people
- 76 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Aug 2018to 31 Dec 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects must have a clinical diagnosis of either Alzheimer's disease, Lewy Body Dementia, or Parkinson's disease.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The Ohio State University
Columbus, Ohio, 43210
Jennifer Icenhour, 614-293-6882, jennifer.icenhour@osumc.edu
About this study
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.
Read the 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.
- Conditions
- Alzheimer's Disease, Lewy Body Dementia, Parkinson's Disease
- Being tested
- DaTscan, F18-AV-45, FDG-PET, APOE genotype, Polysomnogram
- Medical subject headings
- Alzheimer Disease, Lewy Body Disease, Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DaTscanRadiation
A functional imaging of the dopamine transporter using the radioligand [123I]FP-CIT
F18-AV-45Radiation
A brain scan to to measure the extent of amyloid deposition
FDG-PETRadiation
a brain scan measuring total and regional cerebral glucose metabolism wtih positron emission tomographs with 2-(18F)
APOE genotypeGenetic
10 ml of whole blood will be drawn and shipped to Athena Diagnostics for genetic testing.
PolysomnogramProcedure or surgery
Overnight sleep study
Clinical AssessmentBehavioural
Clinical assessments include cognitive, behavioral, and motor evaluations
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Radiation: DaTscan; Radiation: F18-AV-45; Radiation: FDG-PET; Genetic: APOE genotype; Procedure: Polysomnogram; Behavioral: Clinical Assessment | |
| 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. Receives: Radiation: DaTscan; Radiation: F18-AV-45; Radiation: FDG-PET; Genetic: APOE genotype; Procedure: Polysomnogram; Behavioral: Clinical Assessment | |
| 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. Receives: Radiation: DaTscan; Radiation: F18-AV-45; Radiation: FDG-PET; Genetic: APOE genotype; Procedure: Polysomnogram; Behavioral: Clinical Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mini Mental State Examination (MMSE-1)
Global neuropsychological measure
Measured: Baseline
Wechsler Adult Intelligence Scale 4th edition (WAIS-4) Vocabulary
Neuropsychological measure of premorbid IQ estimate
Measured: Baseline
Wechsler Adult Intelligence Scale 4th edition (WAIS-4) Digit Span
Neuropsychological measure of attention
Measured: Baseline
Wechsler Adult Intelligence Scale 4th edition (WAIS-4) Block Design
Neuropsychological measure of visuospatial perception/ reasoning
Measured: Baseline
Wechsler Adult Intelligence Scale 4th edition (WAIS-4) Matrix Reasoning
Neuropsychological measure of executive functioning
Measured: Baseline
Wechsler Adult Intelligence Scale 4th edition (WAIS-4) Reliable Digits (embedded measure)
Neuropsychological measure of effort
Measured: Baseline
Wechsler Memory Scale 3rd ed. (WAIS-3) Spatial Span
Neuropsychological measure of attention
Measured: Baseline
Wechsler Memory Scale 3rd ed. (WAIS-3) Logical Memory 1 & 2
Neuropsychological measure of memory
Measured: Baseline
Trail Making Test A
Neuropsychological measure of executive functioning/psychomotor processing speed
Measured: Baseline
Trail Making Test B
Neuropsychological measure of executive functioning
Measured: Baseline
Boston Naming Test
Neuropsychological measure of language
Measured: Baseline
Controlled Oral Word Association Test (COWAT)- Animal Naming
Neuropsychological measure of language/verbal fluency
Measured: Baseline
Judgment of Line Orientation Standardized Test
Neuropsychological measure of visuospatial perception/ reasoning
Measured: Baseline
Brief Visuospatial Memory Test (BVMT)
Neuropsychological measure of memory
Measured: Baseline
California Verbal Learning Test (CVLT-2)
Neuropsychological measure of memory
Measured: Baseline
Wisconsin Card Sorting Task
Neuropsychological measure of executive functioning
Measured: Baseline
California Verbal Learning Test (CVLT-2) Forced Choice (embedded measure)
Neuropsychological measure of effort
Measured: Baseline
Self Administered Gerocognitive Examination- A brief cognitive assessment instrument for mild cognitive impairment and early dementia
Global neuropsychological measure
Measured: Baseline
Apolipoprotein E (APOE) Genotyping of a whole blood sample
10 ml of whole blood will be drawn for APOE genotyping
Measured: Baseline
Clinical Dementia Rating Scale (CDR)
Global cognitive and functional measure
Measured: Baseline
The Activities of Daily Living (ADL) Standardized Scale
Functional measure
Measured: Baseline
Mayo Fluctuations Scale
Behavioral measure
Measured: Baseline
Neuropsychiatric Inventory (NPI)
Behavioral measure
Measured: Baseline
Beck Depression Inventory 2nd ed.
Behavioral measure
Measured: Baseline
The Modified Somatic Perception Questionnaire
Behavioral measure
Measured: Baseline
The Epworth Sleepiness Scale
Sleep measure
Measured: Baseline
Mayo Sleep Questionnaire-Informant
Sleep measure
Measured: Baseline
Functional Outcomes of Sleep Questionnaire-10
Sleep measure
Measured: Baseline
Part III and IV of the Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
Gait, Mobility, and Coordination Measure
Measured: Baseline
Berg Balance Scale (BBS)
Gait, Mobility, and Coordination Measure
Measured: Baseline
Florbetapir (F18-AV-45) positron emission tomography (amyloid PET)
Imaging to determine extent of amyloid deposition
Measured: Baseline
Single-photon emission computed tomography (SPECT) with the radioligand [123I]FP-CIT
Functional imaging of the dopamine transporter
Measured: Baseline
Positron emission tomography with 2-(18F) fluoro-2-deoxy-d-glucose (FDG-PET)
Imaging to determine total and regional cerebral glucose metabolism
Measured: Baseline
Brain MRI
Imaging including a resting state functional MRI, diffusion tensor imaging, and anatomic imaging
Measured: Baseline
Polysomnogram
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
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2017 (estimated)
- Study start30 Aug 2018
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Douglas Scharre
- Sponsor type
- University, hospital or other
- Collaborators
- Avid Radiopharmaceuticals, Mangurian Foundation
- Responsible party
- Sponsor-investigator, Douglas Scharre, Ohio State University
- Investigators
- Douglas W Scharre, MD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03019757
- Sponsor's protocol ID
- 2014H0415
- Status last verified
- Oct 2026
- First submitted
- 3 Sep 2015
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No