NCT03019757 · Douglas Scharre
Distinguishing Between Alzheimer's Disease, Lewy Body Dementia, and Parkinson's Disease
What this study is about
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.
View original scientific description
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.
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
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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Columbus, Ohio
Collaborators
Avid Radiopharmaceuticals, Mangurian Foundation
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 30, 2025 · Source of record for eligibility and locations