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Completed

NCT Number: NCT04468347

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

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

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Key information

Conditions

Alzheimer Disease Brain Diseases Central Nervous System Diseases Cognition Disorders Cognitive Dysfunction Dementia Mental Disorders Mild Cognitive Impairment Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Flortaucipir F18

Drug

IV injection, 240 megabecquerel (MBq) (6.5 mCi)

Other names: 18F-AV-1451, [F-18]T807, LY3191748, Tauvid

Brain PET scan

Procedure

positron emission tomography (PET) scan of the brain

Primary outcomes

  1. Flortaucipir PET Imaging (Quantitative)

    Time frame: baseline scan

    Flortaucipir PET cortical weighted average standardized uptake value ratio (SUVr). For SUVr, a value of 1 signifies no flortaucipir activity above background, values greater than 1 signify increasing flortaucipir activity in the brain.

  2. Number of Participants With Advanced AD Pattern Flortaucipir PET Scan and Relationship to Cognitive Status

    Time frame: baseline scan

    Scans were visually read independently by two expert readers at the sponsor, blinded to any clinical information. Subject scans were categorized as follows: Advanced AD Scan Pattern (τAD++), Moderate AD Scan Pattern (τAD+), Not AD Scan Pattern (τAD-). For this analysis, subjects with Advanced (τAD++) scans were analyzed vs. the combined Moderate and Not AD pattern groups (τAD+/τAD-). Amyloid status was obtained by florbetapir or carbon-11-labeled Pittsburgh compound B ([C-11] PiB) PET results available from the parent AIBL study.

  3. Number of Participants With AD Pattern Flortaucipir PET Scan and Relationship to Cognitive Status

    Time frame: baseline scan

    Scans were visually read independently by two expert readers at the sponsor, blinded to any clinical information. Subject scans were categorized as follows: Advanced AD Scan Pattern (τAD++), Moderate AD Scan Pattern (τAD+), Not AD Scan Pattern (τAD-). For this analysis, subjects with AD Pattern scans (Advanced [τAD++] and Moderate [τAD+] Scan Pattern) were combined vs. the Not AD pattern group (τAD-). Amyloid status was obtained by florbetapir or carbon-11-labeled Pittsburgh compound B ([C-11] PiB) PET results available from the parent AIBL study.

Sponsors and collaborators

Lead sponsor

Avid Radiopharmaceuticals

Industry

Registry information

Official study title

18F-AV-1451 PET Imaging in the Preclinical, Prodromal and Dementia Phases of Alzheimer's Disease

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Jul 13, 2020
Registry last updated
Sep 25, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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