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

Completed · Early Phase 1

Conditions studied: Alzheimer Disease

In brief

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

Key facts

Study ID

NCT04474405

Run by

Avid Radiopharmaceuticals

People needed

36

Starts

2013-08-16

Expected to finish

2013-12-09

Last updated by the study team

2020-09-25

Who can join

Age: 20 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• WCCT Global, LLC — Cypress, California, United States
• Hoag Memorial Hospital Presbyterian — Newport Beach, California, United States

Full record on ClinicalTrials.gov

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