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      "canonicalId": "NCT03019757",
      "title": "Distinguishing Between Alzheimer's Disease, Lewy Body Dementia, and Parkinson's Disease",
      "scientificTitle": "Distinguishing Between Alzheimer's Disease, Lewy Body Dementia, and Parkinson's Disease",
      "status": "recruiting",
      "studyType": "observational",
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      "conditions": [
        "Alzheimer's Disease",
        "Lewy Body Dementia",
        "Parkinson's Disease"
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          "type": "RADIATION",
          "description": "A functional imaging of the dopamine transporter using the radioligand \\[123I\\]FP-CIT"
        },
        {
          "name": "F18-AV-45",
          "type": "RADIATION",
          "description": "A brain scan to to measure the extent of amyloid deposition"
        },
        {
          "name": "FDG-PET",
          "type": "RADIATION",
          "description": "a brain scan measuring total and regional cerebral glucose metabolism wtih positron emission tomographs with 2-(18F)"
        },
        {
          "name": "APOE genotype",
          "type": "GENETIC",
          "description": "10 ml of whole blood will be drawn and shipped to Athena Diagnostics for genetic testing."
        },
        {
          "name": "Polysomnogram",
          "type": "PROCEDURE",
          "description": "Overnight sleep study"
        },
        {
          "name": "Clinical Assessment",
          "type": "BEHAVIORAL",
          "description": "Clinical assessments include cognitive, behavioral, and motor evaluations"
        }
      ],
      "sponsor": {
        "name": "Douglas Scharre",
        "type": "OTHER"
      },
      "locations": [
        {
          "city": "Columbus",
          "country": "United States",
          "facility": "The Ohio State University"
        }
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      "outcomes": {
        "other": [
          "Lumbar Puncture to obtain cerebrospinal fluid (CSF) that will be stored for future potential evaluation of biomarkers",
          "Post-mortem brain donation to The Ohio State University Neurodegenerative Disease Brain Tissue Repository, for clinicopathological correlations"
        ],
        "primary": [
          "Mini Mental State Examination (MMSE-1)",
          "Wechsler Adult Intelligence Scale 4th edition (WAIS-4) Vocabulary",
          "Wechsler Adult Intelligence Scale 4th edition (WAIS-4) Digit Span",
          "Wechsler Adult Intelligence Scale 4th edition (WAIS-4) Block Design",
          "Wechsler Adult Intelligence Scale 4th edition (WAIS-4) Matrix Reasoning",
          "Wechsler Adult Intelligence Scale 4th edition (WAIS-4) Reliable Digits (embedded measure)",
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          "Wechsler Memory Scale 3rd ed. (WAIS-3) Logical Memory 1 & 2",
          "Trail Making Test A",
          "Trail Making Test B",
          "Boston Naming Test",
          "Controlled Oral Word Association Test (COWAT)- Animal Naming",
          "Judgment of Line Orientation Standardized Test",
          "Brief Visuospatial Memory Test (BVMT)",
          "California Verbal Learning Test (CVLT-2)",
          "Wisconsin Card Sorting Task",
          "California Verbal Learning Test (CVLT-2) Forced Choice (embedded measure)",
          "Self Administered Gerocognitive Examination- A brief cognitive assessment instrument for mild cognitive impairment and early dementia",
          "Apolipoprotein E (APOE) Genotyping of a whole blood sample",
          "Clinical Dementia Rating Scale (CDR)",
          "The Activities of Daily Living (ADL) Standardized Scale",
          "Mayo Fluctuations Scale",
          "Neuropsychiatric Inventory (NPI)",
          "Beck Depression Inventory 2nd ed.",
          "The Modified Somatic Perception Questionnaire",
          "The Epworth Sleepiness Scale",
          "Mayo Sleep Questionnaire-Informant",
          "Functional Outcomes of Sleep Questionnaire-10",
          "Part III and IV of the Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS)",
          "Berg Balance Scale (BBS)",
          "Florbetapir (F18-AV-45) positron emission tomography (amyloid PET)",
          "Single-photon emission computed tomography (SPECT) with the radioligand [123I]FP-CIT",
          "Positron emission tomography with 2-(18F) fluoro-2-deoxy-d-glucose (FDG-PET)",
          "Brain MRI",
          "Polysomnogram"
        ],
        "secondary": []
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        "criteria": "Inclusion Criteria:\n\n* Subjects must meet the standard clinical criteria of the syndromes of interest\n* 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.\n* Subjects must be on stable cognitive and psychoactive medication regimen for the preceding four weeks of enrollment.\n* 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.\n* Subjects must have visual and auditory acuity adequate for testing.\n\nExclusion Criteria:\n\n* 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.\n* active medical disorder that could preclude participation in this protocol\n* Women who are pregnant or are breast feeding\n* severe renal impairment as defined by glomerular filtration rate (GFR) less than 30 (may have increased radiation exposure with the DaTscan).\n* Subjects in whom English is not the 1st language\n* Subjects with educational level less than 12 years\n* 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.",
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        "count": 76
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      "startDate": "2018-08-30",
      "completionDate": "2027-12-31",
      "lastUpdated": "2026-10-15T00:00:00.000Z",
      "firstPosted": "2017-01-13T00:00:00.000Z",
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