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

Completed · Phase 1

Conditions studied: Alzheimer's Disease

In brief

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.

Key facts

Study ID

NCT01992380

Run by

Avid Radiopharmaceuticals

People needed

24

Starts

2013-11-13

Expected to finish

2014-05-30

Last updated by the study team

2020-09-07

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Research Site — Newport Beach, California, United States
• Research Site — New Haven, Connecticut, United States

Full record on ClinicalTrials.gov

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