Follow up 18F-AV-1451 Scan in Confirmatory Cohort Subjects From Study 18F-AV-1451-A05

Avid Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Alzheimer's Disease

Treatments: Drug: Flortaucipir F18; Procedure: PET Scan

Study type: Interventional

Funder types: Industry

Identifiers

NCT02795780

18F-AV-1451-A18

Details and patient eligibility

About

This study will evaluate longitudinal change of tau deposition as measured by flortaucipir F 18 uptake over time.

Enrollment: 79 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Confirmatory cohort subjects who completed the 18F-AV-1451-A05 (NCT02016560) study

Exclusion criteria

• Current clinically significant cardiovascular disease, ECG abnormalities, risk factors for Torsades de Pointes (TdP), or are taking drugs known to cause QT prolongation
• Current clinically significant infectious disease, endocrine or metabolic disease, pulmonary, renal or hepatic impairment, or cancer
• Females of childbearing potential who are not surgically sterile, not refraining from sexual activity or not using reliable methods of contraception
• Have had a non-study related radiopharmaceutical imaging or treatment procedure within 7 days prior to the study imaging session
• Have received or participated in a trial with investigational medications in the past 30 days

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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79 participants in 1 patient group

Follow-up Flortaucipir PET Scan

Experimental group

Treatment:

Drug: Flortaucipir F18

Procedure: PET Scan