18F-AV-1451 Autopsy Study

Avid Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Alzheimer's Disease

Treatments: Drug: Flortaucipir F18; Procedure: PET Scan

Study type: Interventional

Funder types: Industry

Identifiers

NCT02516046

18F-AV-1451-A16

Details and patient eligibility

About

This study is designed to test the relationship between ante-mortem flortaucipir Positron Emission Tomography (PET) imaging and tau neurofibrillary pathology associated with Alzheimer's disease (AD), as measured at autopsy.

Enrollment: 156 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have a projected life expectancy of ≤ 6 months
• Can tolerate a 20 minute PET scan
• Give informed consent or have a legally authorized representative to consent for study procedures and brain donation consistent with the legal requirements of the State in which they die

Exclusion criteria

• Aggressively being treated with life sustaining measures
• Known to have a structural brain lesion that would interfere either with PET imaging or pathological assessment
• Clinically significant infectious disease
• Currently receiving any investigational medications except with permission from the study sponsor
• Participated in an experimental study with an amyloid or tau targeting agent
• Suspected encephalopathy due to alcoholism or end-stage liver disease
• Females of childbearing potential
• History of risk factors for Torsades de Pointes or are currently taking medication known to cause QT prolongation

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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156 participants in 1 patient group

Flortaucipir PET Scan

Experimental group

Treatment:

Drug: Flortaucipir F18

Procedure: PET Scan