Analysis of 18F-AV-1451 PET Imaging in Cognitively Healthy, MCI, and AD Subjects

Completed · Phase 2/Phase 3

Conditions studied: Alzheimer's Disease

In brief

A Phase 2/3 cross-sectional and longitudinal observational study evaluating imaging characteristics of flortaucipir in control subjects and patients with clinically defined MCI and AD dementia (AD).

Key facts

Study ID

NCT02016560

Run by

Avid Radiopharmaceuticals

People needed

383

Starts

2013-12-01

Expected to finish

2017-07-28

Last updated by the study team

2020-09-22

Who can join

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

You may qualify if…

• Exploratory Cognitively Healthy Subjects
• ≥ 20 to ≤ 40 years of age OR ≥ 50 years of age
• Mini-mental state examination (MMSE) ≥ 29
• No significant history of cognitive impairment
• Exploratory MCI Subjects
• ≥ 50 years of age
• MMSE ≥ 24
• Have MCI consistent with National Institute on Aging-Alzheimer's Association (NIA-AA) working group's diagnostic guidelines for AD
• Have a study partner that can report on subject's activities of daily living
• Exploratory AD Subjects
• ≥ 50 years of age
• MMSE > 10
• Have possible or probable AD based on the NIA-AA working group's diagnostic guidelines for AD
• Have a study partner that can report on subject's activities of daily living
• Confirmatory Subjects
• ≥ 50 years of age
• MMSE ≥ 20 and ≤ 27
• Cognitively impaired subjects with either MCI or dementia with a suspected neurodegenerative cause
• Have a study partner that can report on subject's activities of daily living

You may not qualify if…

• Current clinically significant psychiatric disease
• Evidence of structural brain abnormalities
• History of moderate or severe traumatic brain injury
• Current clinically significant cardiovascular disease or ECG abnormalities, or additional risk factors for Torsades de Pointes
• Current clinically significant infectious disease, endocrine or metabolic disease, pulmonary, renal or hepatic impairment, or cancer
• History of alcohol or substance abuse or dependence
• Females of childbearing potential who are not surgically sterile, not refraining from sexual activity or not using reliable methods of contraception
• Have received or participated in a trial with investigational medications in the past 30 days
• Have had a non-study related radiopharmaceutical imaging or treatment procedure within 7 days prior to the study imaging session.

Where it is running

• Banner Alzheimer's Institute — Phoenix, Arizona, United States
• Four Peaks Neurology — Scottsdale, Arizona, United States
• Mayo Clinic — Scottsdale, Arizona, United States
• Banner Sun Health Research Institute — Sun City, Arizona, United States
• UC Irvine — Irvine, California, United States
• Hoag Memorial — Newport Beach, California, United States
• Norther California PET Imaging Center — Sacramento, California, United States
• UC Davis — Sacramento, California, United States
• UC San Francisco — San Francisco, California, United States
• Neurological Research Institute — Santa Monica, California, United States
• Molecular NeuroImaging — New Haven, Connecticut, United States
• Quantum Laboratories — Deerfield Beach, Florida, United States
• 21st Century Oncology — Fort Myers, Florida, United States
• Sandlake Imaging — Orlando, Florida, United States
• Meridien Research — St. Petersburg, Florida, United States
• USF Health Byrd Alzheimer's Center — Tampa, Florida, United States
• Independent Imaging — West Palm Beach, Florida, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Boston University — Boston, Massachusetts, United States
• Alzheimer's Disease Center — Quincy, Massachusetts, United States
• Center for Clinical Imaging Research — St Louis, Missouri, United States
• Las Vegas Radiology — Las Vegas, Nevada, United States
• Center for Brain Health - NYU Langone Medical Center — New York, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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