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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Distinguishing Between Alzheimer's Disease, Lewy Body Dementia, and Parkinson's Disease
- ClinicalTrials.gov ID
- NCT03019757
- Acronym / sponsor ID
- 2014H0415
- Conditions
- Alzheimer's Disease, Lewy Body Dementia, Parkinson's Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Douglas ScharreUniversity, hospital or other
- Collaborators
- Avid Radiopharmaceuticals, Mangurian Foundation
- Study start
- 30 Aug 2018 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 13 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Alzheimer's disease | – | Radiation: DaTscan, Radiation: F18-AV-45, Radiation: FDG-PET, Genetic: APOE genotype, Procedure: Polysomnogram, Behavioral: Clinical AssessmentIndividuals 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. |
| Lewy Body dementia | – | Radiation: DaTscan, Radiation: F18-AV-45, Radiation: FDG-PET, Genetic: APOE genotype, Procedure: Polysomnogram, Behavioral: Clinical AssessmentIndividuals 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. |
| Parkinson's disease | – | Radiation: DaTscan, Radiation: F18-AV-45, Radiation: FDG-PET, Genetic: APOE genotype, Procedure: Polysomnogram, Behavioral: Clinical AssessmentIndividuals 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects must have a clinical diagnosis of either Alzheimer's disease, Lewy Body Dementia, or Parkinson's disease.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DaTscanA functional imaging of the dopamine transporter using the radioligand [123I]FP-CIT | Radiation | Alzheimer's disease, Lewy Body dementia, Parkinson's disease |
| F18-AV-45A brain scan to to measure the extent of amyloid deposition | Radiation | Alzheimer's disease, Lewy Body dementia, Parkinson's disease |
| FDG-PETa brain scan measuring total and regional cerebral glucose metabolism wtih positron emission tomographs with 2-(18F) | Radiation | Alzheimer's disease, Lewy Body dementia, Parkinson's disease |
| APOE genotype10 ml of whole blood will be drawn and shipped to Athena Diagnostics for genetic testing. | Genetic | Alzheimer's disease, Lewy Body dementia, Parkinson's disease |
| PolysomnogramOvernight sleep study | Procedure or surgery | Alzheimer's disease, Lewy Body dementia, Parkinson's disease |
| Clinical AssessmentClinical assessments include cognitive, behavioral, and motor evaluations | Behavioural | Alzheimer's disease, Lewy Body dementia, Parkinson's disease |
Primary outcome
Mini Mental State Examination (MMSE-1)
Time frame: Baseline
Global neuropsychological measure
Wechsler Adult Intelligence Scale 4th edition (WAIS-4) Vocabulary
Time frame: Baseline
Neuropsychological measure of premorbid IQ estimate
Wechsler Adult Intelligence Scale 4th edition (WAIS-4) Digit Span
Time frame: Baseline
Neuropsychological measure of attention
Wechsler Adult Intelligence Scale 4th edition (WAIS-4) Block Design
Time frame: Baseline
Neuropsychological measure of visuospatial perception/ reasoning
Wechsler Adult Intelligence Scale 4th edition (WAIS-4) Matrix Reasoning
Time frame: Baseline
Neuropsychological measure of executive functioning
Wechsler Adult Intelligence Scale 4th edition (WAIS-4) Reliable Digits (embedded measure)
Time frame: Baseline
Neuropsychological measure of effort
Wechsler Memory Scale 3rd ed. (WAIS-3) Spatial Span
Time frame: Baseline
Neuropsychological measure of attention
Wechsler Memory Scale 3rd ed. (WAIS-3) Logical Memory 1 & 2
Time frame: Baseline
Neuropsychological measure of memory
Trail Making Test A
Time frame: Baseline
Neuropsychological measure of executive functioning/psychomotor processing speed
Trail Making Test B
Time frame: Baseline
Neuropsychological measure of executive functioning
Boston Naming Test
Time frame: Baseline
Neuropsychological measure of language
Controlled Oral Word Association Test (COWAT)- Animal Naming
Time frame: Baseline
Neuropsychological measure of language/verbal fluency
Judgment of Line Orientation Standardized Test
Time frame: Baseline
Neuropsychological measure of visuospatial perception/ reasoning
Brief Visuospatial Memory Test (BVMT)
Time frame: Baseline
Neuropsychological measure of memory
California Verbal Learning Test (CVLT-2)
Time frame: Baseline
Neuropsychological measure of memory
Wisconsin Card Sorting Task
Time frame: Baseline
Neuropsychological measure of executive functioning
California Verbal Learning Test (CVLT-2) Forced Choice (embedded measure)
Time frame: Baseline
Neuropsychological measure of effort
Self Administered Gerocognitive Examination- A brief cognitive assessment instrument for mild cognitive impairment and early dementia
Time frame: Baseline
Global neuropsychological measure
Apolipoprotein E (APOE) Genotyping of a whole blood sample
Time frame: Baseline
10 ml of whole blood will be drawn for APOE genotyping
Clinical Dementia Rating Scale (CDR)
Time frame: Baseline
Global cognitive and functional measure
The Activities of Daily Living (ADL) Standardized Scale
Time frame: Baseline
Functional measure
Mayo Fluctuations Scale
Time frame: Baseline
Behavioral measure
Neuropsychiatric Inventory (NPI)
Time frame: Baseline
Behavioral measure
Beck Depression Inventory 2nd ed.
Time frame: Baseline
Behavioral measure
The Modified Somatic Perception Questionnaire
Time frame: Baseline
Behavioral measure
The Epworth Sleepiness Scale
Time frame: Baseline
Sleep measure
Mayo Sleep Questionnaire-Informant
Time frame: Baseline
Sleep measure
Functional Outcomes of Sleep Questionnaire-10
Time frame: Baseline
Sleep measure
Part III and IV of the Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
Time frame: Baseline
Gait, Mobility, and Coordination Measure
Berg Balance Scale (BBS)
Time frame: Baseline
Gait, Mobility, and Coordination Measure
Florbetapir (F18-AV-45) positron emission tomography (amyloid PET)
Time frame: Baseline
Imaging to determine extent of amyloid deposition
Single-photon emission computed tomography (SPECT) with the radioligand [123I]FP-CIT
Time frame: Baseline
Functional imaging of the dopamine transporter
Positron emission tomography with 2-(18F) fluoro-2-deoxy-d-glucose (FDG-PET)
Time frame: Baseline
Imaging to determine total and regional cerebral glucose metabolism
Brain MRI
Time frame: Baseline
Imaging including a resting state functional MRI, diffusion tensor imaging, and anatomic imaging
Polysomnogram
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
Related trials for Alzheimer's Disease
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Not yet recruiting
Acupressure as Long-term Intervention to Slow the Progression of Early/Mild Alzheimer's Disease
Alzheimer's Disease
RecruitingObservational study
Effectiveness and Safety of Disease-Modifying Therapy for Alzheimer's Disease: A Multicenter Retrospective Study
Alzheimer's Disease (AD)
RecruitingPhase 3
A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-1)
Alzheimer Disease
RecruitingPhase 3
A Study of Trontinemab in Cognitively Unimpaired Individuals at Risk for Progression to Symptomatic Alzheimer's Disease
Alzheimer's Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Douglas W Scharre, MD principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer's Disease and Lewy Body Dementia, run by Douglas Scharre at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jennifer Icenhour (614-293-6882, jennifer.icenhour@osumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mini Mental State Examination (MMSE-1) (time frame: Baseline). The study lists 35 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.