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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

242 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-26

Study Completion Date

2019-04-26

Brief Summary

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

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Detailed Description

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Conditions

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Alzheimer Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Physician PET scan readers are participants, blinded to demographic and clinical data from the source PET scans.

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

PET scans were obtained in an open-label fashion.

Study Groups

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Flortaucipir PET Scan

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

Group Type EXPERIMENTAL

flortaucipir F 18

Intervention Type DRUG

No study drug will be administered.

Interventions

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flortaucipir F 18

No study drug will be administered.

Intervention Type DRUG

Other Intervention Names

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18F-AV-1451 [F-18]T807 LY3191748

Eligibility Criteria

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Inclusion 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

Eligible Sex

ALL

Accepts Healthy Volunteers

No