Conditions: Alzheimer Disease
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 36
Healthy volunteers: yes

Brief summary:
This early phase 1 study explored the brain uptake, retention, and safety of flortaucipir and obtained preliminary information regarding dosimetry of flortaucipir.

Detailed description:

Arms:
arm 1: Subjects receiving a brain PET scan after flortaucipir administration arm 2: Subjects receiving a whole body PET scan after flortaucipir administration arm 3: Magnetic resonance imaging (MRI) scans and amyloid scans for subjects previously participating in Study T807000 (NCT01733355)

Interventions: intervention 1: Flortaucipir F18 intervention 2: Brain PET Scan intervention 3: Whole body PET scan intervention 4: Florbetapir F 18 intervention 5: Brain MRI
Intervention descriptions: intervention 1: IV injection, 370 MBq (10 mCi), single dose intervention 2: positron emission tomography (PET) scan of the brain starting immediately after administration (60 minute dynamic imaging plus 4 frames x 5 minutes at approximately 80 minutes post-dose). intervention 3: positron emission tomography (PET) scan of the body from the vertex of the head to the thighs starting immediately following injection and repeated over 6 hours intervention 4: IV injection, 370 MBq (10 mCi), single dose intervention 5: Volume-based T1-weighted Magnetic Resonance Imaging (MRI) of the brain

Protocol document: