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

Avid Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Alzheimer Disease

Treatments: Drug: flortaucipir F 18

Study type: Interventional

Funder types: Industry

Identifiers

NCT03901092

18F-AV-1451-FR01

Details and patient eligibility

About

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

Enrollment: 242 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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242 participants in 1 patient group

Flortaucipir PET Scan

Experimental group

Description:

Scans previously acquired from Study A16 (NCT02516046) and A05 (NCT02016560) will be read by independent, blinded readers.

Treatment:

Drug: flortaucipir F 18