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

Phase 1

Completed

Brief 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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Healthy Volunteer Subjects	Brain PET scan	Healthy males or females 50 years or older with no evidence of cognitive impairment
Probable AD Subjects	Brain PET scan	Subjects 50 years or older with probable Alzheimer's Disease (AD)
MCI subjects	Brain PET scan	Subjects 50 years or older with mild cognitive impairment (MCI)
MCI subjects	Flortaucipir F18	Subjects 50 years or older with mild cognitive impairment (MCI)
Probable AD Subjects	Flortaucipir F18	Subjects 50 years or older with probable Alzheimer's Disease (AD)
Healthy Volunteer Subjects	Flortaucipir F18	Healthy males or females 50 years or older with no evidence of cognitive impairment

Primary Outcome Measures

Name	Time	Method
Test-Retest Reproducibility	110-130 minutes postdose	Evaluate test-retest reproducibility of 18F-AV-1451 for brain imaging of tau in healthy volunteers and subjects with cognitive impairment. Standard uptake value ratios (SUVRs) for each scan, normalized to the cerebellar crus. A combination volume of interest (VOI) = weighted average of parietal, temporal, and occipital regions was used. The protocol pre-specified that test-retest endpoint was to be calculated for the combined group of healthy volunteers and cognitively impaired subjects

Secondary Outcome Measures