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

Alzheimer Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04468347
• Other study ID #: 18F-AV-1451-A08
• Status: Completed
• Phase: Phase 1
• Start date: October 2014
• Est. completion date: February 2018

Study information

• Verified date: September 2020
• Source: Avid Radiopharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: February 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Cognitive Dysfunction
• Dementia
• Mild Cognitive Impairment

Intervention

Drug:
• Flortaucipir F18
IV injection, 240 megabecquerel (MBq) (6.5 mCi)

Procedure:
• Brain PET scan
positron emission tomography (PET) scan of the brain

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Avid Radiopharmaceuticals

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Flortaucipir PET Imaging (Quantitative)	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
Primary	Number of Participants With Advanced AD Pattern Flortaucipir PET Scan and Relationship to Cognitive Status	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 (tAD++), Moderate AD Scan Pattern (tAD+), Not AD Scan Pattern (tAD-). For this analysis, subjects with Advanced (tAD++) scans were analyzed vs. the combined Moderate and Not AD pattern groups (tAD+/tAD-). 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
Primary	Number of Participants With AD Pattern Flortaucipir PET Scan and Relationship to Cognitive Status	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 (tAD++), Moderate AD Scan Pattern (tAD+), Not AD Scan Pattern (tAD-). For this analysis, subjects with AD Pattern scans (Advanced [tAD++] and Moderate [tAD+] Scan Pattern) were combined vs. the Not AD pattern group (tAD-). 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

External Links

•   Link to the Australian Imaging, Biomarker & Lifestyle Flagship Study of Ageing (AIBL) website