A Molecular Anatomic Imaging Analysis of Tau in Progressive Supranuclear Palsy

ConditionProgressive Supranuclear Palsy

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age35+

SponsorMayo Clinic

About this trial

This study is designed to learn more about overall tau burden in the brain of patients with Progressive Supranuclear Palsy (PSP).

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Must be over 35 years of age and present with gradual progression of PSP-related symtoms

Must have an informant or study partner that can provide independent information of functioning.

Must meet criteria for possible or probable Progressive Supranuclear Palsy. To fulfill criteria for possible PSP, subjects must have a gradually progressive disorder with either vertical (upward or downward) supranuclear palsy or both slowing of vertical saccades and prominent postural instability with falls in the first year of disease onset. To fulfill criteria for probable PSP, subjects must have vertical (upward or downward gaze) supranuclear palsy and prominent postural instability with falls in the first year of disease onset.

Disqualifiers

Subjects will be excluded if they meet criteria for another neurodegenerative disease (including corticobasal syndrome, frontotemporal dementia, primary progressive aphasia, Alzheimer's disease, multiple system atrophy and Parkinson's disease) or do not have the symptoms necessary to fulfill inclusion criteria for possible PSP.

Subjects with concurrent illnesses that could account for their symptoms, such as traumatic brain injury, encephalitis, strokes or developmental syndromes will be excluded.

Women that are pregnant or post-partum and breast-feeding will be excluded.

Subjects will be excluded from the study if they have any of the following genetic conditions which can increase the chance of cancer: Cowden disease, Lynch syndrome, hypogammaglobulinemia, Wiskott-Aldrich syndrome, and Down's syndrome.

Trial design

Design model

Single group

Treatments tested in this trial

F-18 AV 1451
Drug
Tau PET scan

Treatment groups

332 Participants

are divided into 1 treatment group

Group A: Tau PET Scan, F-18 AV 1451Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

The investigators will be looking at the amount of Tau protein in the brain of patients with PSP.

Time frame

5 years

Secondary outcomes

Rates of change in tau-PET burden over time.

Time frame

baseline, 1 year

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mayo Clinic

Lead sponsor

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Source ClinicalTrials.gov

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