Exploratory Evaluation of Flortaucipir Injection in Healthy Volunteers and Cognitively Impaired Subjects

Avid Pharmaceuticals

Status and phase: Completed; Early Phase 1

Conditions: Alzheimer Disease

Treatments: Drug: Flortaucipir F18; Procedure: Whole body PET scan; Drug: Florbetapir F 18; Procedure: Brain MRI; Procedure: Brain PET Scan

Study type: Interventional

Funder types: Industry

Identifiers

NCT04474405

18F-AV-1451-A01

Details and patient eligibility

About

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

Enrollment: 36 patients

Sex: All

Ages: 20+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy volunteers had an Mini-Mental State Examination (MMSE) score of ≥ 29;
• MCI due to Alzheimer's disease (AD) consistent with National Institute on Aging (NIA)-Alzheimer's Association working group's on diagnostic guidelines for AD (Alzheimer's Dementia 7:270-9, 2011)
• Possible or probable AD: Met clinical criteria for possible or probable AD based on the NIA-Alzheimer's Association working group's on diagnostic guidelines for AD (Alzheimer's Dementia 7:263-9, 2011)

Exclusion criteria

• Current clinically significant psychiatric disease.
• Evidence of structural abnormalities such as major stroke or mass on MRI that would have made a diagnosis of impairment due to AD unlikely or was likely to interfere with interpretation of a PET scan on MRI.
• Claustrophobic or otherwise unable to tolerate the imaging procedure.
• Current clinically significant cardiovascular disease or clinically significant abnormalities on screening electrocardiogram (including, but not limited to, corrected QT interval >450 msec).
• Current clinically significant infectious disease, endocrine or metabolic disease, pulmonary, renal or hepatic impairment, or cancer
• History of alcohol abuse or substance abuse or dependence
• Female subjects of childbearing potential who were not surgically sterile, not refraining from sexual activity or not using reliable methods of contraception.
• Required medications with a narrow therapeutic window
• Received a non-study related radiopharmaceutical imaging or treatment procedure within 7 days prior to imaging session
• Receiving any investigational medications or had participated in a trial with investigational medications within the last 30 days

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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36 participants in 3 patient groups

Brain flortaucipir PET scan

Experimental group

Description:

Subjects receiving a brain PET scan after flortaucipir administration

Treatment:

Procedure: Brain MRI

Procedure: Brain PET Scan

Drug: Florbetapir F 18

Drug: Flortaucipir F18

Whole body flortaucipir PET scan

Experimental group

Description:

Subjects receiving a whole body PET scan after flortaucipir administration

Treatment:

Procedure: Whole body PET scan

Drug: Flortaucipir F18

MRI and Amyloid Extension Cohort

Other group

Description:

Magnetic resonance imaging (MRI) scans and amyloid scans for subjects previously participating in Study T807000 (NCT01733355)

Treatment:

Procedure: Brain MRI

Procedure: Brain PET Scan

Drug: Florbetapir F 18