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

• Status: Completed
• Trial end date: 2017-07-28
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Avid Radiopharmaceuticals

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

• 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.