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Neuroimaging in Healthy Aging and Senile Dementia (HASD_IND)

NCT04579120

RecruitingN/A

Sponsor: Tammie L. S. Benzinger, MD, PhD

Conditions: Alzheimer Disease

Interventions: [11C]-Pittsburgh Compound B ([11C]PiB), F 18 AV-1451 (Flortaucipir)

Countries: United States

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

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

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

Locations (1)

St Louis, Missouri, United States