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

• Status: Completed
• Trial end date: 2019-04-26
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Avid Radiopharmaceuticals

Criteria

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