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

March 25, 2025 updated by: Douglas Scharre
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
76

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Subjects must have a clinical diagnosis of either Alzheimer's disease, Lewy Body Dementia, or Parkinson's disease.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
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
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.
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
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.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Mini Mental State Examination (MMSE-1)
Time Frame: Baseline
Global neuropsychological measure
Baseline
Wechsler Adult Intelligence Scale 4th edition (WAIS-4) Vocabulary
Time Frame: Baseline
Neuropsychological measure of premorbid IQ estimate
Baseline
Wechsler Adult Intelligence Scale 4th edition (WAIS-4) Digit Span
Time Frame: Baseline
Neuropsychological measure of attention
Baseline
Wechsler Adult Intelligence Scale 4th edition (WAIS-4) Block Design
Time Frame: Baseline
Neuropsychological measure of visuospatial perception/ reasoning
Baseline
Wechsler Adult Intelligence Scale 4th edition (WAIS-4) Matrix Reasoning
Time Frame: Baseline
Neuropsychological measure of executive functioning
Baseline
Wechsler Adult Intelligence Scale 4th edition (WAIS-4) Reliable Digits (embedded measure)
Time Frame: Baseline
Neuropsychological measure of effort
Baseline
Wechsler Memory Scale 3rd ed. (WAIS-3) Spatial Span
Time Frame: Baseline
Neuropsychological measure of attention
Baseline
Wechsler Memory Scale 3rd ed. (WAIS-3) Logical Memory 1 & 2
Time Frame: Baseline
Neuropsychological measure of memory
Baseline
Trail Making Test A
Time Frame: Baseline
Neuropsychological measure of executive functioning/psychomotor processing speed
Baseline
Trail Making Test B
Time Frame: Baseline
Neuropsychological measure of executive functioning
Baseline
Boston Naming Test
Time Frame: Baseline
Neuropsychological measure of language
Baseline
Controlled Oral Word Association Test (COWAT)- Animal Naming
Time Frame: Baseline
Neuropsychological measure of language/verbal fluency
Baseline
Judgment of Line Orientation Standardized Test
Time Frame: Baseline
Neuropsychological measure of visuospatial perception/ reasoning
Baseline
Brief Visuospatial Memory Test (BVMT)
Time Frame: Baseline
Neuropsychological measure of memory
Baseline
California Verbal Learning Test (CVLT-2)
Time Frame: Baseline
Neuropsychological measure of memory
Baseline
Wisconsin Card Sorting Task
Time Frame: Baseline
Neuropsychological measure of executive functioning
Baseline
California Verbal Learning Test (CVLT-2) Forced Choice (embedded measure)
Time Frame: Baseline
Neuropsychological measure of effort
Baseline
Self Administered Gerocognitive Examination- A brief cognitive assessment instrument for mild cognitive impairment and early dementia
Time Frame: Baseline
Global neuropsychological measure
Baseline
Apolipoprotein E (APOE) Genotyping of a whole blood sample
Time Frame: Baseline
10 ml of whole blood will be drawn for APOE genotyping
Baseline
Clinical Dementia Rating Scale (CDR)
Time Frame: Baseline
Global cognitive and functional measure
Baseline
The Activities of Daily Living (ADL) Standardized Scale
Time Frame: Baseline
Functional measure
Baseline
Mayo Fluctuations Scale
Time Frame: Baseline
Behavioral measure
Baseline
Neuropsychiatric Inventory (NPI)
Time Frame: Baseline
Behavioral measure
Baseline
Beck Depression Inventory 2nd ed.
Time Frame: Baseline
Behavioral measure
Baseline
The Modified Somatic Perception Questionnaire
Time Frame: Baseline
Behavioral measure
Baseline
The Epworth Sleepiness Scale
Time Frame: Baseline
Sleep measure
Baseline
Mayo Sleep Questionnaire-Informant
Time Frame: Baseline
Sleep measure
Baseline
Functional Outcomes of Sleep Questionnaire-10
Time Frame: Baseline
Sleep measure
Baseline
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
Baseline
Berg Balance Scale (BBS)
Time Frame: Baseline
Gait, Mobility, and Coordination Measure
Baseline
Florbetapir (F18-AV-45) positron emission tomography (amyloid PET)
Time Frame: Baseline
Imaging to determine extent of amyloid deposition
Baseline
Single-photon emission computed tomography (SPECT) with the radioligand [123I]FP-CIT
Time Frame: Baseline
Functional imaging of the dopamine transporter
Baseline
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
Baseline
Brain MRI
Time Frame: Baseline
Imaging including a resting state functional MRI, diffusion tensor imaging, and anatomic imaging
Baseline
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
Baseline

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Lumbar Puncture to obtain cerebrospinal fluid (CSF) that will be stored for future potential evaluation of biomarkers
Time Frame: Baseline
Optional outcome measure which will be done to obtain samples of CSF
Baseline
Post-mortem brain donation to The Ohio State University Neurodegenerative Disease Brain Tissue Repository, for clinicopathological correlations
Time Frame: Post mortem
Optional outcome measure for patients post-mortem to asses for neuropathologic conditions
Post mortem

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Douglas Scharre

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Avid Radiopharmaceuticals
Mangurian Foundation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Douglas W Scharre, MD, Ohio State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 30, 2018

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 3, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 10, 2017

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 13, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 30, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 25, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2014H0415

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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