Neuroimaging in Healthy Aging and Senile Dementia (HASD_IND)

Conditions

• Alzheimer Disease

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• [11C]-Pittsburgh Compound B ([11C]PiB) — DRUG
  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.
• F 18 AV-1451 (Flortaucipir) — DRUG
  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).

Study Details

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

Key Dates

Start date

Sep 1, 2021

Status verified

Jun 2026

Primary completion

Nov 30, 2027

Completion

Dec 31, 2027

Study Design

Enrollment

650 participants (estimated)

Arms

• Arm: African American
  African American participants receiving \[11C\]-Pittsburgh Compound B (\[11C\]PiB) F 18 AV-1451 (Flortaucipir) for imaging.
• Arm: Non-Hispanic White
  Non-Hispanic White participants receiving \[11C\]-Pittsburgh Compound B (\[11C\]PiB) F 18 AV-1451 (Flortaucipir) for imaging.

Primary Outcome Measure

AD Biomarkers seen on Amyloid PET at Baseline and Years 1, 2, and/or 3 [ Time Frame: 5 years ]

Central Contacts

• Kelley Jackson, BA
  314-362-1558
  [email protected]

Locations (1)

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