Flortaucipir PET Imaging in the Preclinical, Prodromal and Dementia Phases of Alzheimer's Disease

Avid Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Alzheimer Disease; Mild Cognitive Impairment

Treatments: Drug: Flortaucipir F18; Procedure: Brain PET scan

Study type: Interventional

Funder types: Industry

Identifiers

NCT04468347

18F-AV-1451-A08

Details and patient eligibility

About

A Phase 1 study designed to evaluate imaging characteristics of flortaucipir in the preclinical, prodromal and dementia phases of Alzheimer's disease.

Full description

The Australian Imaging Biomarkers and Lifestyle Study (AIBL) is a multicenter multidisciplinary study of Alzheimer's disease and aging funded by the Commonwealth Scientific and Industrial Research Organisation (CSIRO) Flagship Initiative, involving research centers in both Victoria and Western Australia. The goal of the A08 protocol was to further investigate the positron emission tomography (PET) imaging results with flortaucipir in patients across the AD spectrum from individuals with subjective memory complaints (SMC) to those with dementia, based on recruitment into the parent AIBL study.

Enrollment: 89 patients

Sex: All

Ages: 60+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Meet all inclusion criteria for the AIBL study protocol, with amyloid PET conducted or planned and MRI available
• Subjects in the MCI and AD groups required to have a reliable caregiver capable of providing information about the subjects' symptoms

Exclusion criteria

• lifetime history of schizophrenia, schizoaffective disorder, or bipolar disorder
• history of electroconvulsive therapy
• MRI contraindicated
• claustrophobic or, otherwise, unable to tolerate the imaging procedure
• current clinically significant cardiovascular disease or clinically significant abnormalities on screening electrocardiogram
• history of additional risk factors for Torsades de Pointes
• current clinically significant infectious disease, endocrine or metabolic disease, or pulmonary, renal, or hepatic impairment that the investigator believes would affect study participation
• history of cancer (other than skin or in situ prostate cancer) within the previous 5 years
• current drug or alcohol abuse/dependence
• history of alcohol abuse/dependence with 2 years of the onset of the symptoms of dementia
• females of childbearing potential who were not surgically sterile, not refraining from sexual activity, or not using reliable methods of contraception

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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89 participants in 4 patient groups

Alzheimer's disease (AD)

Experimental group

Description:

Alzheimer's disease subjects receiving a flortaucipir PET scan at baseline and 12 months

Treatment:

Procedure: Brain PET scan

Drug: Flortaucipir F18

Mild cognitive impairment (MCI)

Experimental group

Description:

Mild cognitive impairment subjects receiving a flortaucipir PET scan at baseline and 12 months

Treatment:

Procedure: Brain PET scan

Drug: Flortaucipir F18

Subjective memory complainers (SMC)

Experimental group

Description:

Subjective memory complainers receiving a flortaucipir PET scan at baseline and 12 months

Treatment:

Procedure: Brain PET scan

Drug: Flortaucipir F18

Cognitively normal (CN)

Experimental group

Description:

Cognitively normal subjects receiving a flortaucipir PET scan at baseline and 12 months

Treatment:

Procedure: Brain PET scan

Drug: Flortaucipir F18