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

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ClinicalTrials.gov Identifier: NCT03019757
Recruitment Status : Not yet recruiting
First Posted : January 13, 2017
Last Update Posted : July 20, 2018
Sponsor:
Collaborators:
Avid Radiopharmaceuticals
Mangurian Foundation
Information provided by (Responsible Party):
Douglas Scharre, Ohio State University

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.

Condition or disease Intervention/treatment
Alzheimer's Disease Lewy Body Dementia Parkinson's Disease Radiation: DaTscan Radiation: F18-AV-45 Radiation: FDG-PET Genetic: APOE genotype Procedure: Polysomnogram Behavioral: Clinical Assessment

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 : Observational
Estimated Enrollment : 76 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Distinguishing Between Alzheimer's Disease, Lewy Body Dementia, and Parkinson's Disease
Estimated Study Start Date : August 2018
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020


Group/Cohort Intervention/treatment
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




Primary Outcome Measures :
  1. Mini Mental State Examination (MMSE-1) [ Time Frame: Baseline ]
    Global neuropsychological measure

  2. Wechsler Adult Intelligence Scale 4th edition (WAIS-4) Vocabulary [ Time Frame: Baseline ]
    Neuropsychological measure of premorbid IQ estimate

  3. Wechsler Adult Intelligence Scale 4th edition (WAIS-4) Digit Span [ Time Frame: Baseline ]
    Neuropsychological measure of attention

  4. Wechsler Adult Intelligence Scale 4th edition (WAIS-4) Block Design [ Time Frame: Baseline ]
    Neuropsychological measure of visuospatial perception/ reasoning

  5. Wechsler Adult Intelligence Scale 4th edition (WAIS-4) Matrix Reasoning [ Time Frame: Baseline ]
    Neuropsychological measure of executive functioning

  6. Wechsler Adult Intelligence Scale 4th edition (WAIS-4) Reliable Digits (embedded measure) [ Time Frame: Baseline ]
    Neuropsychological measure of effort

  7. Wechsler Memory Scale 3rd ed. (WAIS-3) Spatial Span [ Time Frame: Baseline ]
    Neuropsychological measure of attention

  8. Wechsler Memory Scale 3rd ed. (WAIS-3) Logical Memory 1 & 2 [ Time Frame: Baseline ]
    Neuropsychological measure of memory

  9. Trail Making Test A [ Time Frame: Baseline ]
    Neuropsychological measure of executive functioning/psychomotor processing speed

  10. Trail Making Test B [ Time Frame: Baseline ]
    Neuropsychological measure of executive functioning

  11. Boston Naming Test [ Time Frame: Baseline ]
    Neuropsychological measure of language

  12. Controlled Oral Word Association Test (COWAT)- Animal Naming [ Time Frame: Baseline ]
    Neuropsychological measure of language/verbal fluency

  13. Judgment of Line Orientation Standardized Test [ Time Frame: Baseline ]
    Neuropsychological measure of visuospatial perception/ reasoning

  14. Brief Visuospatial Memory Test (BVMT) [ Time Frame: Baseline ]
    Neuropsychological measure of memory

  15. California Verbal Learning Test (CVLT-2) [ Time Frame: Baseline ]
    Neuropsychological measure of memory

  16. Wisconsin Card Sorting Task [ Time Frame: Baseline ]
    Neuropsychological measure of executive functioning

  17. California Verbal Learning Test (CVLT-2) Forced Choice (embedded measure) [ Time Frame: Baseline ]
    Neuropsychological measure of effort

  18. Self Administered Gerocognitive Examination- A brief cognitive assessment instrument for mild cognitive impairment and early dementia [ Time Frame: Baseline ]
    Global neuropsychological measure

  19. Apolipoprotein E (APOE) Genotyping of a whole blood sample [ Time Frame: Baseline ]
    10 ml of whole blood will be drawn for APOE genotyping

  20. Clinical Dementia Rating Scale (CDR) [ Time Frame: Baseline ]
    Global cognitive and functional measure

  21. The Activities of Daily Living (ADL) Standardized Scale [ Time Frame: Baseline ]
    Functional measure

  22. Mayo Fluctuations Scale [ Time Frame: Baseline ]
    Behavioral measure

  23. Neuropsychiatric Inventory (NPI) [ Time Frame: Baseline ]
    Behavioral measure

  24. Beck Depression Inventory 2nd ed. [ Time Frame: Baseline ]
    Behavioral measure

  25. The Modified Somatic Perception Questionnaire [ Time Frame: Baseline ]
    Behavioral measure

  26. The Epworth Sleepiness Scale [ Time Frame: Baseline ]
    Sleep measure

  27. Mayo Sleep Questionnaire-Informant [ Time Frame: Baseline ]
    Sleep measure

  28. Functional Outcomes of Sleep Questionnaire-10 [ Time Frame: Baseline ]
    Sleep measure

  29. 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

  30. Berg Balance Scale (BBS) [ Time Frame: Baseline ]
    Gait, Mobility, and Coordination Measure

  31. Florbetapir (F18-AV-45) positron emission tomography (amyloid PET) [ Time Frame: Baseline ]
    Imaging to determine extent of amyloid deposition

  32. Single-photon emission computed tomography (SPECT) with the radioligand [123I]FP-CIT [ Time Frame: Baseline ]
    Functional imaging of the dopamine transporter

  33. 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

  34. Brain MRI [ Time Frame: Baseline ]
    Imaging including a resting state functional MRI, diffusion tensor imaging, and anatomic imaging

  35. 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


Other Outcome Measures:
  1. 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

  2. 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


Biospecimen Retention:   Samples With DNA
Participants will have the option to participate in a lumbar puncture sub-study as well as a brain donation program. These samples will be retained in the Buckeye Biospecimen Repository or the Buckeye Brain Bank, respectively.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03019757


Contacts
Contact: Jennifer Icenhour 614-293-6882 jennifer.icenhour@osumc.edu

Locations
United States, Ohio
The Ohio State University Not yet recruiting
Columbus, Ohio, United States, 43210
Contact: Jennifer Icenhour    614-293-6882    jennifer.icenhour@osumc.edu   
Sponsors and Collaborators
Douglas Scharre
Avid Radiopharmaceuticals
Mangurian Foundation
Investigators
Principal Investigator: Douglas W Scharre, MD Ohio State University

Responsible Party: Douglas Scharre, Professor, Clinical, Ohio State University
ClinicalTrials.gov Identifier: NCT03019757     History of Changes
Other Study ID Numbers: 2014H0415
First Posted: January 13, 2017    Key Record Dates
Last Update Posted: July 20, 2018
Last Verified: July 2018

Additional relevant MeSH terms:
Parkinson Disease
Alzheimer Disease
Dementia
Lewy Body Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Tauopathies
Neurocognitive Disorders
Mental Disorders