Clinical trial NCT03019757: Distinguishing Between Alzheimer's Disease, Lewy Body Dementia, and Parkinson's Disease
Official title: Distinguishing Between Alzheimer's Disease, Lewy Body Dementia, and Parkinson's Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Alzheimer's Disease
Lewy Body Dementia
Parkinson's Disease
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: Avid Radiopharmaceuticals
name: Mangurian Foundation
First posted: 2017-01-13
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Mini Mental State Examination (MMSE-1)
timeFrame: Baseline
measure: Wechsler Adult Intelligence Scale 4th edition (WAIS-4) Vocabulary
timeFrame: Baseline
measure: Wechsler Adult Intelligence Scale 4th edition (WAIS-4) Digit Span
timeFrame: Baseline
measure: Wechsler Adult Intelligence Scale 4th edition (WAIS-4) Block Design
timeFrame: Baseline
measure: Wechsler Adult Intelligence Scale 4th edition (WAIS-4) Matrix Reasoning
timeFrame: Baseline
measure: Wechsler Adult Intelligence Scale 4th edition (WAIS-4) Reliable Digits (embedded measure)
timeFrame: Baseline
measure: Wechsler Memory Scale 3rd ed. (WAIS-3) Spatial Span
timeFrame: Baseline
measure: Wechsler Memory Scale 3rd ed. (WAIS-3) Logical Memory 1 & 2
timeFrame: Baseline
measure: Trail Making Test A
timeFrame: Baseline
measure: Trail Making Test B
timeFrame: Baseline
measure: Boston Naming Test
timeFrame: Baseline
measure: Controlled Oral Word Association Test (COWAT)- Animal Naming
timeFrame: Baseline
measure: Judgment of Line Orientation Standardized Test
timeFrame: Baseline
measure: Brief Visuospatial Memory Test (BVMT)
timeFrame: Baseline
measure: California Verbal Learning Test (CVLT-2)
timeFrame: Baseline
measure: Wisconsin Card Sorting Task
timeFrame: Baseline
measure: California Verbal Learning Test (CVLT-2) Forced Choice (embedded measure)
timeFrame: Baseline
measure: Self Administered Gerocognitive Examination- A brief cognitive assessment instrument for mild cognitive impairment and early dementia
timeFrame: Baseline
measure: Apolipoprotein E (APOE) Genotyping of a whole blood sample
timeFrame: Baseline
measure: Clinical Dementia Rating Scale (CDR)
timeFrame: Baseline
measure: The Activities of Daily Living (ADL) Standardized Scale
timeFrame: Baseline
measure: Mayo Fluctuations Scale
timeFrame: Baseline
measure: Neuropsychiatric Inventory (NPI)
timeFrame: Baseline
measure: Beck Depression Inventory 2nd ed.
timeFrame: Baseline
measure: The Modified Somatic Perception Questionnaire
timeFrame: Baseline
measure: The Epworth Sleepiness Scale
timeFrame: Baseline
measure: Mayo Sleep Questionnaire-Informant
timeFrame: Baseline
measure: Functional Outcomes of Sleep Questionnaire-10
timeFrame: Baseline
measure: Part III and IV of the Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
timeFrame: Baseline
measure: Berg Balance Scale (BBS)
timeFrame: Baseline
measure: Florbetapir (F18-AV-45) positron emission tomography (amyloid PET)
timeFrame: Baseline
measure: Single-photon emission computed tomography (SPECT) with the radioligand [123I]FP-CIT
timeFrame: Baseline
measure: Positron emission tomography with 2-(18F) fluoro-2-deoxy-d-glucose (FDG-PET)
timeFrame: Baseline
measure: Brain MRI
timeFrame: Baseline
measure: Polysomnogram
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
measure: Lumbar Puncture to obtain cerebrospinal fluid (CSF) that will be stored for future potential evaluation of biomarkers
timeFrame: Baseline
measure: Post-mortem brain donation to The Ohio State University Neurodegenerative Disease Brain Tissue Repository, for clinicopathological correlations
timeFrame: Post mortem
Locations:
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
Study officials:
affiliation: Ohio State University
name: Douglas W Scharre, MD
role: PRINCIPAL_INVESTIGATOR
References: