<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03019757</url>
  </required_header>
  <id_info>
    <org_study_id>2014H0415</org_study_id>
    <nct_id>NCT03019757</nct_id>
  </id_info>
  <brief_title>Distinguishing Between Alzheimer's Disease, Lewy Body Dementia, and Parkinson's Disease</brief_title>
  <official_title>Distinguishing Between Alzheimer's Disease, Lewy Body Dementia, and Parkinson's Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Douglas Scharre</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Avid Radiopharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Mangurian Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Ohio State University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study is designed to characterize the clinical, neuropsychological, polysomnographic, and&#xD;
      neuroimaging findings among subjects with Alzheimer's disease, Lewy Body dementia, and&#xD;
      Parkinsons' Disease.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will use structural and functional MRIs, daTscans, fluorodeoxyglucose (FDG) PET&#xD;
      scans, Amyvid PET scans, polysomnographs, neuropsychological testing, cerebrospinal fluid in&#xD;
      willing participants to distinguish between a diagnosis of Alzheimer's disease, Lewy Body&#xD;
      dementia, and Parkinson's Disease. All subjects will have a clinical evaluation, physical&#xD;
      examination including vital signs and orthostatic blood pressures and pulses, neurological&#xD;
      examination including UPDRS evaluation, genetic blood sample collection, neuropsychological&#xD;
      testing, polysomnogram, and neuroimaging. The study partner will also be interviewed for&#xD;
      completion of all of the behavioral and functional measures.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 30, 2018</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">December 2023</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Mini Mental State Examination (MMSE-1)</measure>
    <time_frame>Baseline</time_frame>
    <description>Global neuropsychological measure</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Wechsler Adult Intelligence Scale 4th edition (WAIS-4) Vocabulary</measure>
    <time_frame>Baseline</time_frame>
    <description>Neuropsychological measure of premorbid IQ estimate</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Wechsler Adult Intelligence Scale 4th edition (WAIS-4) Digit Span</measure>
    <time_frame>Baseline</time_frame>
    <description>Neuropsychological measure of attention</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Wechsler Adult Intelligence Scale 4th edition (WAIS-4) Block Design</measure>
    <time_frame>Baseline</time_frame>
    <description>Neuropsychological measure of visuospatial perception/ reasoning</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Wechsler Adult Intelligence Scale 4th edition (WAIS-4) Matrix Reasoning</measure>
    <time_frame>Baseline</time_frame>
    <description>Neuropsychological measure of executive functioning</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Wechsler Adult Intelligence Scale 4th edition (WAIS-4) Reliable Digits (embedded measure)</measure>
    <time_frame>Baseline</time_frame>
    <description>Neuropsychological measure of effort</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Wechsler Memory Scale 3rd ed. (WAIS-3) Spatial Span</measure>
    <time_frame>Baseline</time_frame>
    <description>Neuropsychological measure of attention</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Wechsler Memory Scale 3rd ed. (WAIS-3) Logical Memory 1 &amp; 2</measure>
    <time_frame>Baseline</time_frame>
    <description>Neuropsychological measure of memory</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Trail Making Test A</measure>
    <time_frame>Baseline</time_frame>
    <description>Neuropsychological measure of executive functioning/psychomotor processing speed</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Trail Making Test B</measure>
    <time_frame>Baseline</time_frame>
    <description>Neuropsychological measure of executive functioning</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Boston Naming Test</measure>
    <time_frame>Baseline</time_frame>
    <description>Neuropsychological measure of language</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Controlled Oral Word Association Test (COWAT)- Animal Naming</measure>
    <time_frame>Baseline</time_frame>
    <description>Neuropsychological measure of language/verbal fluency</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Judgment of Line Orientation Standardized Test</measure>
    <time_frame>Baseline</time_frame>
    <description>Neuropsychological measure of visuospatial perception/ reasoning</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Brief Visuospatial Memory Test (BVMT)</measure>
    <time_frame>Baseline</time_frame>
    <description>Neuropsychological measure of memory</description>
  </primary_outcome>
  <primary_outcome>
    <measure>California Verbal Learning Test (CVLT-2)</measure>
    <time_frame>Baseline</time_frame>
    <description>Neuropsychological measure of memory</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Wisconsin Card Sorting Task</measure>
    <time_frame>Baseline</time_frame>
    <description>Neuropsychological measure of executive functioning</description>
  </primary_outcome>
  <primary_outcome>
    <measure>California Verbal Learning Test (CVLT-2) Forced Choice (embedded measure)</measure>
    <time_frame>Baseline</time_frame>
    <description>Neuropsychological measure of effort</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Self Administered Gerocognitive Examination- A brief cognitive assessment instrument for mild cognitive impairment and early dementia</measure>
    <time_frame>Baseline</time_frame>
    <description>Global neuropsychological measure</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Apolipoprotein E (APOE) Genotyping of a whole blood sample</measure>
    <time_frame>Baseline</time_frame>
    <description>10 ml of whole blood will be drawn for APOE genotyping</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Clinical Dementia Rating Scale (CDR)</measure>
    <time_frame>Baseline</time_frame>
    <description>Global cognitive and functional measure</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The Activities of Daily Living (ADL) Standardized Scale</measure>
    <time_frame>Baseline</time_frame>
    <description>Functional measure</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mayo Fluctuations Scale</measure>
    <time_frame>Baseline</time_frame>
    <description>Behavioral measure</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Neuropsychiatric Inventory (NPI)</measure>
    <time_frame>Baseline</time_frame>
    <description>Behavioral measure</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Beck Depression Inventory 2nd ed.</measure>
    <time_frame>Baseline</time_frame>
    <description>Behavioral measure</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The Modified Somatic Perception Questionnaire</measure>
    <time_frame>Baseline</time_frame>
    <description>Behavioral measure</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The Epworth Sleepiness Scale</measure>
    <time_frame>Baseline</time_frame>
    <description>Sleep measure</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mayo Sleep Questionnaire-Informant</measure>
    <time_frame>Baseline</time_frame>
    <description>Sleep measure</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Functional Outcomes of Sleep Questionnaire-10</measure>
    <time_frame>Baseline</time_frame>
    <description>Sleep measure</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part III and IV of the Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS)</measure>
    <time_frame>Baseline</time_frame>
    <description>Gait, Mobility, and Coordination Measure</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Berg Balance Scale (BBS)</measure>
    <time_frame>Baseline</time_frame>
    <description>Gait, Mobility, and Coordination Measure</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Florbetapir (F18-AV-45) positron emission tomography (amyloid PET)</measure>
    <time_frame>Baseline</time_frame>
    <description>Imaging to determine extent of amyloid deposition</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Single-photon emission computed tomography (SPECT) with the radioligand [123I]FP-CIT</measure>
    <time_frame>Baseline</time_frame>
    <description>Functional imaging of the dopamine transporter</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Positron emission tomography with 2-(18F) fluoro-2-deoxy-d-glucose (FDG-PET)</measure>
    <time_frame>Baseline</time_frame>
    <description>Imaging to determine total and regional cerebral glucose metabolism</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Brain MRI</measure>
    <time_frame>Baseline</time_frame>
    <description>Imaging including a resting state functional MRI, diffusion tensor imaging, and anatomic imaging</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Polysomnogram</measure>
    <time_frame>Baseline</time_frame>
    <description>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</description>
  </primary_outcome>
  <other_outcome>
    <measure>Lumbar Puncture to obtain cerebrospinal fluid (CSF) that will be stored for future potential evaluation of biomarkers</measure>
    <time_frame>Baseline</time_frame>
    <description>Optional outcome measure which will be done to obtain samples of CSF</description>
  </other_outcome>
  <other_outcome>
    <measure>Post-mortem brain donation to The Ohio State University Neurodegenerative Disease Brain Tissue Repository, for clinicopathological correlations</measure>
    <time_frame>Post mortem</time_frame>
    <description>Optional outcome measure for patients post-mortem to asses for neuropathologic conditions</description>
  </other_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">76</enrollment>
  <condition>Alzheimer's Disease</condition>
  <condition>Lewy Body Dementia</condition>
  <condition>Parkinson's Disease</condition>
  <arm_group>
    <arm_group_label>Alzheimer's disease</arm_group_label>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Lewy Body dementia</arm_group_label>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Parkinson's disease</arm_group_label>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>DaTscan</intervention_name>
    <description>A functional imaging of the dopamine transporter using the radioligand [123I]FP-CIT</description>
    <arm_group_label>Alzheimer's disease</arm_group_label>
    <arm_group_label>Lewy Body dementia</arm_group_label>
    <arm_group_label>Parkinson's disease</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>F18-AV-45</intervention_name>
    <description>A brain scan to to measure the extent of amyloid deposition</description>
    <arm_group_label>Alzheimer's disease</arm_group_label>
    <arm_group_label>Lewy Body dementia</arm_group_label>
    <arm_group_label>Parkinson's disease</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>FDG-PET</intervention_name>
    <description>a brain scan measuring total and regional cerebral glucose metabolism wtih positron emission tomographs with 2-(18F)</description>
    <arm_group_label>Alzheimer's disease</arm_group_label>
    <arm_group_label>Lewy Body dementia</arm_group_label>
    <arm_group_label>Parkinson's disease</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Genetic</intervention_type>
    <intervention_name>APOE genotype</intervention_name>
    <description>10 ml of whole blood will be drawn and shipped to Athena Diagnostics for genetic testing.</description>
    <arm_group_label>Alzheimer's disease</arm_group_label>
    <arm_group_label>Lewy Body dementia</arm_group_label>
    <arm_group_label>Parkinson's disease</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Polysomnogram</intervention_name>
    <description>Overnight sleep study</description>
    <arm_group_label>Alzheimer's disease</arm_group_label>
    <arm_group_label>Lewy Body dementia</arm_group_label>
    <arm_group_label>Parkinson's disease</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Clinical Assessment</intervention_name>
    <description>Clinical assessments include cognitive, behavioral, and motor evaluations</description>
    <arm_group_label>Alzheimer's disease</arm_group_label>
    <arm_group_label>Lewy Body dementia</arm_group_label>
    <arm_group_label>Parkinson's disease</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Participants will have the option to participate in a lumbar puncture sub-study as well as a&#xD;
      brain donation program. These samples will be retained in the Buckeye Biospecimen Repository&#xD;
      or the Buckeye Brain Bank, respectively.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects must have a clinical diagnosis of either Alzheimer's disease, Lewy Body Dementia,&#xD;
        or Parkinson's disease.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects must meet the standard clinical criteria of the syndromes of interest&#xD;
&#xD;
          -  All subjects must have enough cognitive abilities to complete study procedures, which&#xD;
             will be operationally defined as having a Mini Mental State Examination (MMSE) score&#xD;
             greater or equal to 10.&#xD;
&#xD;
          -  Subjects must be on stable cognitive and psychoactive medication regimen for the&#xD;
             preceding four weeks of enrollment.&#xD;
&#xD;
          -  Subjects must have a responsible study partner that either lives with them or is in&#xD;
             regular contact with them at least 4 out of 7 days per week.&#xD;
&#xD;
          -  Subjects must have visual and auditory acuity adequate for testing.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any other condition (other than the primary diagnosis), which in the opinion of the&#xD;
             investigators might contribute to the syndrome of dementia or complicate its&#xD;
             assessment.&#xD;
&#xD;
          -  active medical disorder that could preclude participation in this protocol&#xD;
&#xD;
          -  Women who are pregnant or are breast feeding&#xD;
&#xD;
          -  severe renal impairment as defined by glomerular filtration rate (GFR) less than 30&#xD;
             (may have increased radiation exposure with the DaTscan).&#xD;
&#xD;
          -  Subjects in whom English is not the 1st language&#xD;
&#xD;
          -  Subjects with educational level less than 12 years&#xD;
&#xD;
          -  Subjects who have ever participated in an experimental study with an amyloid targeting&#xD;
             agent unless it can be documented that the subject received only placebo during the&#xD;
             course of the trial.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Douglas W Scharre, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ohio State University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jennifer Icenhour</last_name>
    <phone>614-293-6882</phone>
    <email>jennifer.icenhour@osumc.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>The Ohio State University</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jennifer Icenhour</last_name>
      <phone>614-293-6882</phone>
      <email>jennifer.icenhour@osumc.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>September 3, 2015</study_first_submitted>
  <study_first_submitted_qc>January 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 13, 2017</study_first_posted>
  <last_update_submitted>September 23, 2022</last_update_submitted>
  <last_update_submitted_qc>September 23, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 27, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Ohio State University</investigator_affiliation>
    <investigator_full_name>Douglas Scharre</investigator_full_name>
    <investigator_title>Professor, Clinical</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Parkinson Disease</mesh_term>
    <mesh_term>Alzheimer Disease</mesh_term>
    <mesh_term>Dementia</mesh_term>
    <mesh_term>Lewy Body Disease</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03019757
org study id: 2014H0415
nct id: NCT03019757
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
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.
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.
observational model: Cohort
time perspective: Cross-Sectional
measure: Mini Mental State Examination (MMSE-1)
time frame: Baseline
description: Global neuropsychological measure
measure: Wechsler Adult Intelligence Scale 4th edition (WAIS-4) Vocabulary
time frame: Baseline
description: Neuropsychological measure of premorbid IQ estimate
measure: Wechsler Adult Intelligence Scale 4th edition (WAIS-4) Digit Span
time frame: Baseline
description: Neuropsychological measure of attention
measure: Wechsler Adult Intelligence Scale 4th edition (WAIS-4) Block Design
time frame: Baseline
description: Neuropsychological measure of visuospatial perception/ reasoning
measure: Wechsler Adult Intelligence Scale 4th edition (WAIS-4) Matrix Reasoning
time frame: Baseline
description: Neuropsychological measure of executive functioning
measure: Wechsler Adult Intelligence Scale 4th edition (WAIS-4) Reliable Digits (embedded measure)
time frame: Baseline
description: Neuropsychological measure of effort
measure: Wechsler Memory Scale 3rd ed. (WAIS-3) Spatial Span
time frame: Baseline
description: Neuropsychological measure of attention
measure: Wechsler Memory Scale 3rd ed. (WAIS-3) Logical Memory 1 & 2
time frame: Baseline
description: Neuropsychological measure of memory
measure: Trail Making Test A
time frame: Baseline
description: Neuropsychological measure of executive functioning/psychomotor processing speed
measure: Trail Making Test B
time frame: Baseline
description: Neuropsychological measure of executive functioning
measure: Boston Naming Test
time frame: Baseline
description: Neuropsychological measure of language
measure: Controlled Oral Word Association Test (COWAT)- Animal Naming
time frame: Baseline
description: Neuropsychological measure of language/verbal fluency
measure: Judgment of Line Orientation Standardized Test
time frame: Baseline
description: Neuropsychological measure of visuospatial perception/ reasoning
measure: Brief Visuospatial Memory Test (BVMT)
time frame: Baseline
description: Neuropsychological measure of memory
measure: California Verbal Learning Test (CVLT-2)
time frame: Baseline
description: Neuropsychological measure of memory
measure: Wisconsin Card Sorting Task
time frame: Baseline
description: Neuropsychological measure of executive functioning
measure: California Verbal Learning Test (CVLT-2) Forced Choice (embedded measure)
time frame: Baseline
description: Neuropsychological measure of effort
measure: Self Administered Gerocognitive Examination- A brief cognitive assessment instrument for mild cognitive impairment and early dementia
time frame: Baseline
description: Global neuropsychological measure
measure: Apolipoprotein E (APOE) Genotyping of a whole blood sample
time frame: Baseline
description: 10 ml of whole blood will be drawn for APOE genotyping
measure: Clinical Dementia Rating Scale (CDR)
time frame: Baseline
description: Global cognitive and functional measure
measure: The Activities of Daily Living (ADL) Standardized Scale
time frame: Baseline
description: Functional measure
measure: Mayo Fluctuations Scale
time frame: Baseline
description: Behavioral measure
measure: Neuropsychiatric Inventory (NPI)
time frame: Baseline
description: Behavioral measure
measure: Beck Depression Inventory 2nd ed.
time frame: Baseline
description: Behavioral measure
measure: The Modified Somatic Perception Questionnaire
time frame: Baseline
description: Behavioral measure
measure: The Epworth Sleepiness Scale
time frame: Baseline
description: Sleep measure
measure: Mayo Sleep Questionnaire-Informant
time frame: Baseline
description: Sleep measure
measure: Functional Outcomes of Sleep Questionnaire-10
time frame: Baseline
description: Sleep measure
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
description: Gait, Mobility, and Coordination Measure
measure: Berg Balance Scale (BBS)
time frame: Baseline
description: Gait, Mobility, and Coordination Measure
measure: Florbetapir (F18-AV-45) positron emission tomography (amyloid PET)
time frame: Baseline
description: Imaging to determine extent of amyloid deposition
measure: Single-photon emission computed tomography (SPECT) with the radioligand [123I]FP-CIT
time frame: Baseline
description: Functional imaging of the dopamine transporter
measure: Positron emission tomography with 2-(18F) fluoro-2-deoxy-d-glucose (FDG-PET)
time frame: Baseline
description: Imaging to determine total and regional cerebral glucose metabolism
measure: Brain MRI
time frame: Baseline
description: Imaging including a resting state functional MRI, diffusion tensor imaging, and anatomic imaging
measure: Polysomnogram
time frame: Baseline
description: 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
measure: Lumbar Puncture to obtain cerebrospinal fluid (CSF) that will be stored for future potential evaluation of biomarkers
time frame: Baseline
description: Optional outcome measure which will be done to obtain samples of CSF
measure: Post-mortem brain donation to The Ohio State University Neurodegenerative Disease Brain Tissue Repository, for clinicopathological correlations
time frame: Post mortem
description: Optional outcome measure for patients post-mortem to asses for neuropathologic conditions
arm group label: Alzheimer's disease
description: 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.
arm group label: Lewy Body dementia
description: 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.
arm group label: Parkinson's disease
description: 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.
intervention type: Radiation
intervention name: DaTscan
description: A functional imaging of the dopamine transporter using the radioligand [123I]FP-CIT
arm group label: Alzheimer's disease
arm group label: Lewy Body dementia
arm group label: Parkinson's disease
intervention type: Radiation
intervention name: F18-AV-45
description: A brain scan to to measure the extent of amyloid deposition
arm group label: Alzheimer's disease
arm group label: Lewy Body dementia
arm group label: Parkinson's disease
intervention type: Radiation
intervention name: FDG-PET
description: a brain scan measuring total and regional cerebral glucose metabolism wtih positron emission tomographs with 2-(18F)
arm group label: Alzheimer's disease
arm group label: Lewy Body dementia
arm group label: Parkinson's disease
intervention type: Genetic
intervention name: APOE genotype
description: 10 ml of whole blood will be drawn and shipped to Athena Diagnostics for genetic testing.
arm group label: Alzheimer's disease
arm group label: Lewy Body dementia
arm group label: Parkinson's disease
intervention type: Procedure
intervention name: Polysomnogram
description: Overnight sleep study
arm group label: Alzheimer's disease
arm group label: Lewy Body dementia
arm group label: Parkinson's disease
intervention type: Behavioral
intervention name: Clinical Assessment
description: Clinical assessments include cognitive, behavioral, and motor evaluations
arm group label: Alzheimer's disease
arm group label: Lewy Body dementia
arm group label: Parkinson's disease
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.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Douglas W Scharre, MD
role: Principal Investigator
affiliation: Ohio State University
last name: Jennifer Icenhour
phone: 614-293-6882
email: jennifer.icenhour@osumc.edu
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: Ohio State University
investigator full name: Douglas Scharre
investigator title: Professor, Clinical
mesh term: Parkinson Disease
mesh term: Alzheimer Disease
mesh term: Dementia
mesh term: Lewy Body Disease