Clinical trial NCT04468347: Flortaucipir PET Imaging in the Preclinical, Prodromal and Dementia Phases of Alzheimer's Disease
Official title: 18F-AV-1451 PET Imaging in the Preclinical, Prodromal and Dementia Phases of Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Alzheimer Disease
Mild Cognitive Impairment
Lead sponsor: Avid Radiopharmaceuticals
Sponsor class: INDUSTRY
First posted: 2020-07-13
Enrollment: 89
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Flortaucipir PET Imaging (Quantitative)
timeFrame: baseline scan
measure: Number of Participants With Advanced AD Pattern Flortaucipir PET Scan and Relationship to Cognitive Status
timeFrame: baseline scan
measure: Number of Participants With AD Pattern Flortaucipir PET Scan and Relationship to Cognitive Status
timeFrame: baseline scan
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Avid Radiopharmaceuticals, Inc.
name: Chief Medical Officer
role: STUDY_DIRECTOR
References: