A Reader Study to Assess Accuracy and Reliability of Flortaucipir F 18 Positron Emission Tomography (PET) Scan Interpretation

A Reader Study to Assess Accuracy and Reliability of Flortaucipir F 18 PET Scan Interpretation

This study will evaluate the performance of physician readers trained to read flortaucipir-PET (positron emission tomography) scans.

Scan Reader Criteria (5 total):

• Board-certified in radiology or nuclear medicine
• Professional experience interpreting PET scans
• Naive to study protocol
• No previous training or exposure to Avid Flortaucipir F 18 read methodology

Scan Criteria:

- Previous enrollment in Study A05 confirmatory cohort (NCT02016560), or A16 (NCT02516046)

Scan Study Population Criteria for FR01 (A05 confirmatory cohort):

• Cognitively-impaired
• mild cognitive impairment (MCI) or dementia with suspected neurodegenerative cause
• mini-mental status exam (MMSE) score of 20-27, inclusive

Scan Study Population Criteria for FR01 (Study A16):

• Subjects at end of life (less than or equal to 6 months)
• Imaged with flortaucipir F18 and came to autopsy