Neuroimaging in Healthy Aging and Senile Dementia (HASD_IND)

Обзор

To identify factors that signal the transition from asymptomatic (preclinical) to symptomatic Alzheimer disease (AD).

Подробное описание

The purpose of this research study is to evaluate the structure and function of the brain in healthy aging and early Alzheimer's disease using positron emission tomography (PET), magnetic resonance imaging (MRI), and computed tomography (CT) imaging. The study involves imaging the brain to detect the presence of amyloid deposits (plaques in the brain). Amyloid is a protein that may be related to dementia of Alzheimer's disease (DAT).

This study will use radioactive tracers called C-11 Pittsburgh Compound B (PIB) and F 18/ AV-1451 (Flortaucipir) which binds to beta amyloid and tau in the brain. These compounds are considered investigational, which means that they have not been approved by the United States Food and Drug Administration (FDA).

Вмешательства

• Препарат [11C]-Pittsburgh Compound B ([11C]PiB)
  A dosage range between 6.0 - 20.0 mCi (222-740 MBq) is planned for \[11C\] PIB. A PET-certified medical professional will prepare and administer the \[11C\] PIB tracer. Prior to the administration, the dosage will be assayed in a dose calibrator and diluted with 0.9% sodium chloride (normal saline) up to a total 20 mL syringe volume. Participants will receive a maximum intravenous bolus injection of 20.0 mCi of \[11C\] PIB followed by a 10 mL 0.9% sodium chloride (normal saline) flush.
• Препарат F 18 AV-1451 (Flortaucipir)
  A dosage range between 6.5 - 10.0 mCi (240-370MBq) is planned for \[18F\] AV-1451. A PET-certified medical professional will prepare and administer the \[18F\] AV-1451tracer. Prior to the administration, the dosage will be assayed in a dose calibrator. The volume of 18F-AV-1451 dose should not be adjusted by adding normal saline to the syringe. Participants will receive a maximum intravenous bolus injection of 10.0 mCi of \[18F\] AV-1451 followed by a 10 mL flush of 0.9% sodium chloride (normal

Первичные конечные точки

• AD Biomarkers seen on Amyloid PET at Baseline and Years 1, 2, and/or 3 [Срок оценки: 5 years]
• AD Biomarkers seen on Tau PET at Baseline and Years 1, 2, and/or 3 [Срок оценки: 5 years]
• AD Biomarkers seen on MRI at Baseline and Years 1, 2, and/or 3 [Срок оценки: 5 years]
• Compare and Correlate Predictive Ability of Biomarkers Seen with Different Imaging Variables for Onset of Symptoms [Срок оценки: 5 years]

Вторичные конечные точки (2)

• Compare and Correlate Predictive Ability of Biomarkers Seen with Other Types of Variables for Onset of Symptoms [Срок оценки: 5 years]
• Disparities for molecular biomarkers of AD in non-Hispanic white (NHW) and African American (AA) older adults [Срок оценки: 5 years]

Критерии участия

Критерии включения

• Male or female, any race
• Age > 18 years
• Participation in one of the ongoing projects affiliated with the Knight ADRC at Washington University and referred by the MAP staff and a Washington University physician.
• Normal cognition or early-stage symptomatic AD
• Willing and able to undergo study procedures.
• Capacity to give informed consent and follow study procedures

Критерии исключения

• Has any condition that, in the Investigator's opinion, could increase risk to the participant, limit the participant's ability to tolerate the research procedures, or interfere with the collection/analysis of the data (e.g., participants with severe chronic back pain might not be able to lie still during the scanning procedures);
• Has hypersensitivity to either AV-1451 or PIB or any of its excipients;
• Contraindications to PET, CT or MRI (e.g. electronic medical devices, inability to lie still for extended periods) that make it unsafe for the individual to participate;
• Severe claustrophobia;
• Currently pregnant or breast-feeding. Women must agree to avoid becoming pregnant and must agree to refrain from sexual activity or to use reliable contraceptive methods for 24 hours following administration of Flortaucipir injection;
• Must not have participated in any clinical trial involving a study drug or device within the 30-days prior to study enrollment;
• Must not participate in another drug or device study prior to the end of this study participation;
• Current or recent (within 12 months prior to screening) participation in research studies involving radioactive agents such that the total research-related radiation dose to the participant in any given year would exceed the limits set forth in the U.S. Code of Federal Regulations (CFR) Title 21 Section 361.1.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?FR=361.1

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Другое

Центры проведения

США · 1 центр

• Washington University School of Medicine — St Louis

Идентификаторы

NCT: NCT04579120 · 201906009

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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