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

September 3, 2020 updated by: Avid Radiopharmaceuticals

18F-AV-1451 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

89

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Alzheimer's disease (AD)
Alzheimer's disease subjects receiving a flortaucipir PET scan at baseline and 12 months
Procedure: Brain PET scan
positron emission tomography (PET) scan of the brain
Drug: Flortaucipir F18
IV injection, 240 megabecquerel (MBq) (6.5 mCi)
Other Names:
  • 18F-AV-1451
  • [F-18]T807
  • LY3191748
  • Tauvid
EXPERIMENTAL: Mild cognitive impairment (MCI)
Mild cognitive impairment subjects receiving a flortaucipir PET scan at baseline and 12 months
Procedure: Brain PET scan
positron emission tomography (PET) scan of the brain
Drug: Flortaucipir F18
IV injection, 240 megabecquerel (MBq) (6.5 mCi)
Other Names:
  • 18F-AV-1451
  • [F-18]T807
  • LY3191748
  • Tauvid
EXPERIMENTAL: Subjective memory complainers (SMC)
Subjective memory complainers receiving a flortaucipir PET scan at baseline and 12 months
Procedure: Brain PET scan
positron emission tomography (PET) scan of the brain
Drug: Flortaucipir F18
IV injection, 240 megabecquerel (MBq) (6.5 mCi)
Other Names:
  • 18F-AV-1451
  • [F-18]T807
  • LY3191748
  • Tauvid
EXPERIMENTAL: Cognitively normal (CN)
Cognitively normal subjects receiving a flortaucipir PET scan at baseline and 12 months
Procedure: Brain PET scan
positron emission tomography (PET) scan of the brain
Drug: Flortaucipir F18
IV injection, 240 megabecquerel (MBq) (6.5 mCi)
Other Names:
  • 18F-AV-1451
  • [F-18]T807
  • LY3191748
  • Tauvid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline scan
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.
baseline scan
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.
baseline scan

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Avid Radiopharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 1, 2014

Primary Completion (ACTUAL)

February 1, 2018

Study Completion (ACTUAL)

February 1, 2018

Study Registration Dates

First Submitted

July 8, 2020

First Submitted That Met QC Criteria

July 8, 2020

First Posted (ACTUAL)

July 13, 2020

Study Record Updates

Last Update Posted (ACTUAL)

September 25, 2020

Last Update Submitted That Met QC Criteria

September 3, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18F-AV-1451-A08

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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