Status:
COMPLETED
Flortaucipir PET Imaging in the Preclinical, Prodromal and Dementia Phases of Alzheimer's Disease
Lead Sponsor:
Avid Radiopharmaceuticals
Conditions:
Alzheimer Disease
Mild Cognitive Impairment
Eligibility:
All Genders
60+ years
Phase:
PHASE1
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 Org...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2018
Estimated Enrollment :
89 Patients enrolled
Trial Details
Trial ID
NCT04468347
Start Date
October 1 2014
End Date
February 1 2018
Last Update
September 25 2020
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