Tau Imaging in Subjects With Progressive Supranuclear Palsy, Corticobasal Degeneration and Health… (NCT02167594) | Clinical Trial Compass
CompletedPhase 1
Tau Imaging in Subjects With Progressive Supranuclear Palsy, Corticobasal Degeneration and Healthy Volunteers
United States29 participantsStarted 2014-08-12
Plain-language summary
This study will evaluate flortaucipir for brain imaging of tau in subjects with progressive supranuclear palsy (PSP), corticobasal degeneration (CBD) and healthy volunteers.
Who can participate
Age range50 Years – 85 Years
SexALL
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Inclusion Criteria:
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
Exclusion Criteria:
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 s…
What they're measuring
1
Flortaucipir Imaging in PSP, CBD and Healthy Volunteers