Status:
COMPLETED
Exploratory Evaluation of Flortaucipir Injection in Healthy Volunteers and Cognitively Impaired Subjects
Lead Sponsor:
Avid Radiopharmaceuticals
Conditions:
Alzheimer Disease
Eligibility:
All Genders
20+ years
Phase:
EARLY_PHASE1
Brief Summary
This early phase 1 study explored the brain uptake, retention, and safety of flortaucipir and obtained preliminary information regarding dosimetry of flortaucipir.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 16 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 9 2013
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT04474405
Start Date
August 16 2013
End Date
December 9 2013
Last Update
September 25 2020
Active Locations (2)
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1
WCCT Global, LLC
Cypress, California, United States, 90630
2
Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States, 92658