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

Parkinson's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03019757
• Other study ID #: 2014H0415
• Status: Recruiting
• Start date: August 30, 2018
• Est. completion date: December 2024

Study information

• Verified date: October 2023
• Source: Ohio State University
• Contact: Jennifer Icenhour
• Phone: 614-293-6882
• Email: jennifer.icenhour[@]osumc.edu
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 76
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease
• Dementia
• Lewy Body Dementia
• Lewy Body Disease
• Parkinson Disease
• Parkinson's Disease

Intervention

Radiation:
• DaTscan
A functional imaging of the dopamine transporter using the radioligand [123I]FP-CIT
• F18-AV-45
A brain scan to to measure the extent of amyloid deposition
• 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

Locations

Country	Name	City	State
United States	The Ohio State University	Columbus	Ohio

Sponsors (3)

Lead Sponsor	Collaborator
Douglas Scharre	Avid Radiopharmaceuticals, Mangurian Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Lumbar Puncture to obtain cerebrospinal fluid (CSF) that will be stored for future potential evaluation of biomarkers	Optional outcome measure which will be done to obtain samples of CSF	Baseline
Other	Post-mortem brain donation to The Ohio State University Neurodegenerative Disease Brain Tissue Repository, for clinicopathological correlations	Optional outcome measure for patients post-mortem to asses for neuropathologic conditions	Post mortem
Primary	Mini Mental State Examination (MMSE-1)	Global neuropsychological measure	Baseline
Primary	Wechsler Adult Intelligence Scale 4th edition (WAIS-4) Vocabulary	Neuropsychological measure of premorbid IQ estimate	Baseline
Primary	Wechsler Adult Intelligence Scale 4th edition (WAIS-4) Digit Span	Neuropsychological measure of attention	Baseline
Primary	Wechsler Adult Intelligence Scale 4th edition (WAIS-4) Block Design	Neuropsychological measure of visuospatial perception/ reasoning	Baseline
Primary	Wechsler Adult Intelligence Scale 4th edition (WAIS-4) Matrix Reasoning	Neuropsychological measure of executive functioning	Baseline
Primary	Wechsler Adult Intelligence Scale 4th edition (WAIS-4) Reliable Digits (embedded measure)	Neuropsychological measure of effort	Baseline
Primary	Wechsler Memory Scale 3rd ed. (WAIS-3) Spatial Span	Neuropsychological measure of attention	Baseline
Primary	Wechsler Memory Scale 3rd ed. (WAIS-3) Logical Memory 1 & 2	Neuropsychological measure of memory	Baseline
Primary	Trail Making Test A	Neuropsychological measure of executive functioning/psychomotor processing speed	Baseline
Primary	Trail Making Test B	Neuropsychological measure of executive functioning	Baseline
Primary	Boston Naming Test	Neuropsychological measure of language	Baseline
Primary	Controlled Oral Word Association Test (COWAT)- Animal Naming	Neuropsychological measure of language/verbal fluency	Baseline
Primary	Judgment of Line Orientation Standardized Test	Neuropsychological measure of visuospatial perception/ reasoning	Baseline
Primary	Brief Visuospatial Memory Test (BVMT)	Neuropsychological measure of memory	Baseline
Primary	California Verbal Learning Test (CVLT-2)	Neuropsychological measure of memory	Baseline
Primary	Wisconsin Card Sorting Task	Neuropsychological measure of executive functioning	Baseline
Primary	California Verbal Learning Test (CVLT-2) Forced Choice (embedded measure)	Neuropsychological measure of effort	Baseline
Primary	Self Administered Gerocognitive Examination- A brief cognitive assessment instrument for mild cognitive impairment and early dementia	Global neuropsychological measure	Baseline
Primary	Apolipoprotein E (APOE) Genotyping of a whole blood sample	10 ml of whole blood will be drawn for APOE genotyping	Baseline
Primary	Clinical Dementia Rating Scale (CDR)	Global cognitive and functional measure	Baseline
Primary	The Activities of Daily Living (ADL) Standardized Scale	Functional measure	Baseline
Primary	Mayo Fluctuations Scale	Behavioral measure	Baseline
Primary	Neuropsychiatric Inventory (NPI)	Behavioral measure	Baseline
Primary	Beck Depression Inventory 2nd ed.	Behavioral measure	Baseline
Primary	The Modified Somatic Perception Questionnaire	Behavioral measure	Baseline
Primary	The Epworth Sleepiness Scale	Sleep measure	Baseline
Primary	Mayo Sleep Questionnaire-Informant	Sleep measure	Baseline
Primary	Functional Outcomes of Sleep Questionnaire-10	Sleep measure	Baseline
Primary	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	Baseline
Primary	Berg Balance Scale (BBS)	Gait, Mobility, and Coordination Measure	Baseline
Primary	Florbetapir (F18-AV-45) positron emission tomography (amyloid PET)	Imaging to determine extent of amyloid deposition	Baseline
Primary	Single-photon emission computed tomography (SPECT) with the radioligand [123I]FP-CIT	Functional imaging of the dopamine transporter	Baseline
Primary	Positron emission tomography with 2-(18F) fluoro-2-deoxy-d-glucose (FDG-PET)	Imaging to determine total and regional cerebral glucose metabolism	Baseline
Primary	Brain MRI	Imaging including a resting state functional MRI, diffusion tensor imaging, and anatomic imaging	Baseline
Primary	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	Baseline