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Набор по приглашению NCT00950430

Imaging of Brain Amyloid Plaques in the Aging Population

Фаза IV С лечением Alzheimer's Disease Dementia With Lewy Bodies Frontotemporal Dementia Vascular Dementia

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: Pittsburgh Compound B (C-11 PiB), F-18 FDG, Tau (18-F-AV-1451).
Кому может быть актуально
Состояния в реестре: Alzheimer's Disease, Dementia With Lewy Bodies, Frontotemporal Dementia, Vascular Dementia. Базовые параметры: 30 лет — 100 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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Официальное название

Brain Amyloid Imaging With Pittsburgh Compound B in Normal Aging, Mild Cognitive Impairment, and Dementia

Обзор

This is a prospective, open label, non-therapeutic, diagnostic imaging study. The purpose of this study is to utilize Pittsburgh Compound B positron emission imaging (PiB PET) to ascertain the relationship between change in amyloid burden over time, and concurrent change in clinical status.

Подробное описание

Identification of risk factors and biomarkers of neurodegenerative disease is essential in caring for the growing numbers of elderly. Imaging biomarkers provide non-invasive ways to look at brain function. A new PET imaging agent, Pittsburgh Compound B (PiB), that identifies brain amyloid is an exciting development in brain imaging that needs to be studied. We plan to study this imaging technique in normal volunteers and patients with a variety of neurodegenerative diseases to determine its utility. Long term followup of these subjects will allow us to understand the predictive ability of this new test.

Вмешательства

  • Препарат Pittsburgh Compound B (C-11 PiB)
    Repeat these scans approximately every 24-30 months for up to 10 years in those with all three PETs or 20 years in those with only PiB PET and FDG PET. A second PiB PET, TAU PET and/or FDG PET may be administered within a year if needed to ensure a completed exam for analysis in the rare case of exam failure or data loss.
  • Препарат F-18 FDG
    Repeat these scans approximately every 24-30 months for up to 10 years in those with all three PETs or 20 years in those with only PiB PET and FDG PET. A second PiB PET, TAU PET and/or FDG PET may be administered within a year if needed to ensure a completed exam for analysis in the rare case of exam failure or data loss.
  • Препарат Tau (18-F-AV-1451)
    1. PIB PET scan, Tau PET scan and/or FDG PET scan 2. Repeat these scans approximately every 24-30 months for up to 10 years in those with all three PETs or 20 years in those with only PiB PET and FDG PET. A second PiB PET, TAU PET and/or FDG PET may be administered within a year if needed to ensure a completed exam for analysis in the rare case of exam failure or data loss. ECG will be performed on subjects who have not had previous ECG test at Mayo to rule out prolonged QT interval prior to PET

Первичные конечные точки

  • To understand the predictive ability of PiB PET imaging for neurodegenerative diseases. [Срок оценки: up to 20 years]
Вторичные конечные точки (4)
  • Using PiB-PET, to ascertain cross-sectionally the magnitude and the spatial distribution of amyloid deposition in the brain in subjects who are clinically classified as CN, MCI, and demented. [Срок оценки: up to 20 years]
  • To identify the relationship between amyloid burden and the risk of progression from CN at baseline to MCI. [Срок оценки: up to 20 years]
  • To identify the relationship between amyloid burden and the risk of progression from MCI at baseline to dementia. [Срок оценки: up to 20 years]
  • To measure longitudinal change in amyloid burden and cognition and characterize the correlation between change on serial PiB-PET measures vs. FDG measures and concurrent change on continuous measures of cognitive performance. [Срок оценки: up to 20 years]

Критерии участия

Критерии включения

  • Age 30-100
  • Subjects who have completed or are scheduled to undergo the neurological evaluation procedures in the Mayo Clinic Study of Aging, Mayo ADRC, or Mayo neurodegenerative disease clinics.

Критерии исключения

  • Subjects unable to lie down without moving for 10 minutes
  • Women who are pregnant or cannot stop breast feeding for 24 hours at the time of scanning
  • Claustrophobic patients unable to tolerate the scans
  • Standard safety exclusionary criteria for MRI such as metallic foreign bodies, pacemaker, etc.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Диагностика

Центры проведения

США · 1 центр
  • Mayo Clinic — Rochester

Идентификаторы

NCT: NCT00950430 · 08-005553 · U01AG006786 · R01AG011378

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗