18F-AV-1451 High Resolution Autopsy Study

Avid Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Alzheimer's Disease

Treatments: Drug: Flortaucipir F18

Study type: Interventional

Funder types: Industry

Identifiers

NCT02350634

18F-AV-1451-A13

Details and patient eligibility

About

The study is designed to examine the relationship between imaging results detected on a 18F-AV-1451 PET scan and pathology found at autopsy within six months of imaging.

Enrollment: 3 patients

Sex: All

Ages: 60 to 89 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Projected life expectancy ≤ 6 months

Exclusion criteria

• Primary brain tumor, known metastases to the brain, central nervous system lymphoma
• Major, focal structural brain lesion
• Aggressively being treated with life sustaining measures
• Clinically significant infectious disease
• History of risk factors for Torsades de Pointes or are currently taking medication known to cause QT prolongation
• Have received or participated in a trial with investigational medications in the past 30 days
• Females of childbearing potential who are pregnant or not using adequate contraception

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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3 participants in 1 patient group

Autopsy Cohort

Experimental group

Description:

End-of-life subjects (life expectancy \< 6 months) consenting to brain donation at autopsy. Subjects will receive a single IV bolus injection of 370 MBq(10 mCi) of flortaucipir F18.

Treatment:

Drug: Flortaucipir F18