A Study of Flortaucipir PET in Healthy Volunteers and Cognitively Impaired Subjects

• Status: Completed
• Trial end date: 2014-05-30
• Target enrollment: 0
• Participant gender: All

Summary

This study will test if two flortaucipir PET scans up to 4 weeks apart in healthy volunteers, MCI and AD subjects provide the same results.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Avid Radiopharmaceuticals

Criteria

Inclusion Criteria:

• Healthy Volunteers

• Male or female subjects ≥ 50 years of age

• Mini-mental state examination (MMSE) ≥ 29

• MCI Subjects

• Male or female 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

• Probable AD Subjects

• Male or female subjects ≥ 50 years of age

• MMSE > 10

• Meet clinical criteria for 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

Exclusion Criteria:

• Current clinically significant psychiatric disease

• Evidence of structural brain abnormalities

• Evidence of dementing illness other than AD

• 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.