Neuroimaging in Healthy Aging and Senile Dementia (HASD_IND) (HASD_PIB_IND)

Tammie L. S. Benzinger, MD, PhD

Status

Enrolling

Conditions

Alzheimer Disease

Treatments

Drug: F 18 AV-1451 (Flortaucipir)

Drug: [11C]-Pittsburgh Compound B ([11C]PiB)

Study type

Observational

Funder types

Other

Identifiers

NCT04579120

201906009

Details and patient eligibility

About

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

Full description

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).

Enrollment

650 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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