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Идёт набор NCT03019757

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

— Наблюдательное Alzheimer's Disease Lewy Body Dementia Parkinson's Disease

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: DaTscan, F18-AV-45, FDG-PET, APOE genotype.
Кому может быть актуально
Состояния в реестре: Alzheimer's Disease, Lewy Body Dementia, Parkinson's Disease. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
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Обзор

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.

Подробное описание

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.

Вмешательства

  • Лучевая терапия DaTscan
    A functional imaging of the dopamine transporter using the radioligand \[123I\]FP-CIT
  • Лучевая терапия F18-AV-45
    A brain scan to to measure the extent of amyloid deposition
  • Лучевая терапия FDG-PET
    a brain scan measuring total and regional cerebral glucose metabolism wtih positron emission tomographs with 2-(18F)
  • Генная терапия APOE genotype
    10 ml of whole blood will be drawn and shipped to Athena Diagnostics for genetic testing.
  • Процедура Polysomnogram
    Overnight sleep study
  • Поведенческое Clinical Assessment
    Clinical assessments include cognitive, behavioral, and motor evaluations

Первичные конечные точки

  • Mini Mental State Examination (MMSE-1) [Срок оценки: Baseline]
  • Wechsler Adult Intelligence Scale 4th edition (WAIS-4) Vocabulary [Срок оценки: Baseline]
  • Wechsler Adult Intelligence Scale 4th edition (WAIS-4) Digit Span [Срок оценки: Baseline]
  • Wechsler Adult Intelligence Scale 4th edition (WAIS-4) Block Design [Срок оценки: Baseline]
  • Wechsler Adult Intelligence Scale 4th edition (WAIS-4) Matrix Reasoning [Срок оценки: Baseline]
  • Wechsler Adult Intelligence Scale 4th edition (WAIS-4) Reliable Digits (embedded measure) [Срок оценки: Baseline]
  • Wechsler Memory Scale 3rd ed. (WAIS-3) Spatial Span [Срок оценки: Baseline]
  • Wechsler Memory Scale 3rd ed. (WAIS-3) Logical Memory 1 & 2 [Срок оценки: Baseline]
  • Trail Making Test A [Срок оценки: Baseline]
  • Trail Making Test B [Срок оценки: Baseline]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

США · 1 центр
  • The Ohio State University — Columbus

Идентификаторы

NCT: NCT03019757 · 2014H0415

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗