Tau Imaging in Subjects With Progressive Supranuclear Palsy, Corticobasal Degeneration and Healthy Volunteers

Completed · Phase 1

Conditions studied: Progressive Supranuclear Palsy, Corticobasal Degeneration

In brief

This study will evaluate flortaucipir for brain imaging of tau in subjects with progressive supranuclear palsy (PSP), corticobasal degeneration (CBD) and healthy volunteers.

Key facts

Study ID

NCT02167594

Run by

Avid Radiopharmaceuticals

People needed

29

Starts

2014-08-12

Expected to finish

2016-07-11

Last updated by the study team

2020-08-28

Who can join

Age: 50 and older, up to 85. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Cognitively Healthy Volunteers
• Mini-mental state examination (MMSE) ≥ 28
• No history of cognitive decline or parkinsonian motor disorder
• CBD and PSP subjects
• Able to walk 10 steps with minimal assistance
• MMSE ≥ 14 and ≤ 30
• Subject has a reliable study partner who agrees to accompany subject to visits and spends at least 5 hours per week with the subject
• PSP subjects only
• Meet National Institute of Neurological Disorders and Stroke - Society for Progressive Supranuclear Palsy (NINDS-SPSP) probable or possible PSP criteria as modified for the Neuroprotection and Natural History Parkinson Plus Syndromes (NNIPPS) clinical trial
• CBD subjects only
• Meets 2013 consensus criteria for possible or probable corticobasal degeneration, corticobasal syndrome (CBS) subtype

You may not qualify if…

• All subjects
• Have evidence of structural abnormalities such as vascular disease, large strokes or severe white matter disease or other mass lesion on screening MRI
• Claustrophobia
• Current clinically significant cardiovascular disease or clinically significant abnormalities on screening electrocardiogram (e.g. corrected QT interval >450 msec)
• Have a history of risk factors for Torsades de Pointes (e.g. heart failure, hypokalemia, family history of long QT syndrome)
• Have a current clinically significant infectious disease, endocrine or metabolic disease, pulmonary, renal or hepatic impairment, or cancer
• Females of childbearing potential who are not surgically sterile, not refraining from sexual activity or not using reliable methods of contraception
• Have received or participated in a trial with investigational medications in the past 30 days
• Have had a non-study related radiopharmaceutical imaging or treatment procedure within 7 days prior to the study imaging session
• Have a history of neuroleptic use for a prolonged period of time or within the past 6 months
• PSP and CBD subjects
• Have evidence of amyloid deposition
• Meet National Institute on Aging-Alzheimer's Association criteria for probable Alzheimer's Disease
• Have any other neurological condition other than CBS or PSP that could account for cognitive or motor deficits
• Serum or plasma progranulin level less than one standard deviation below the normal subject mean for the laboratory performing the assay
• Have a high-risk family history suggestive of tar DNA binding protein (TDP)-43 pathology or known mutations

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• UCSD Movement Disorder Clinic — La Jolla, California, United States
• UCSF Neurosciences Clinical Research Unit — San Francisco, California, United States
• Molecular Neuroimaging — New Haven, Connecticut, United States
• Perelman School of Medicine — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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