NCT04579120

Neuroimaging in Healthy Aging and Senile Dementia (HASD_IND)

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 650 (estimated)
• Sponsor: Tammie L. S. Benzinger, MD, PhD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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).

Conditions

• Alzheimer Disease

Interventions

Type	Name	Description
DRUG	[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.
DRUG	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 saline).

Timeline

• Start date: 2021-09-01
• Primary completion: 2025-11-01
• Completion: 2025-12-01
• First posted: 2020-10-08
• Last updated: 2024-07-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study