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

• Status: Completed
• Trial end date: 2018-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Avid Radiopharmaceuticals

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