A Molecular Anatomic Imaging Analysis of Tau in Progressive Supranuclear Palsy

NCT02605785 | Recruiting FDA Drug

• 2 other identifiers: 15-004618R01NS089757
• Study Type: interventional
• Target: 332
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Progressive Supranuclear Palsy

Keywords

PSP

Outcome Measures

Primary Outcomes (1)

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

  5 years

Secondary Outcomes (1)

• Rates of change in tau-PET burden over time.

  baseline, 1 year

Study Arms (1)

Tau PET Scan, F-18 AV 1451

EXPERIMENTAL

All subjects will received a Tau PET scan.

Drug: F-18 AV 1451

Interventions

F-18 AV 1451 DRUG

Tau PET scan

Also known as: Tau binding agent

Tau PET Scan, F-18 AV 1451

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Subjects will also be excluded if MRI is contraindicated (metal in head, cardiac pace maker, e.t.c.), if there is severe claustrophobia, if there are conditions that may confound brain imaging studies (e.g. structural abnormalities, including subdural hematoma, intracranial neoplasm or large cortical infarcts), or if they are medically unstable or are on medications that might affect brain structure or metabolism (e.g. chemotherapy).
• Subjects will also be excluded if they do not have an informant, or do not consent to research.

Sponsors & Collaborators

• National Institute of Neurological Disorders and Stroke (NINDS): collaborator
• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Supranuclear Palsy, Progressive

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Ophthalmoplegia; Ocular Motility Disorders; Cranial Nerve Diseases; Tauopathies; Neurodegenerative Diseases; Paralysis; Neurologic Manifestations; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jennifer Whitwell, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah M Boland, CCRP

CONTACT

507-284-3863; boland.sarah@mayo.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Neurology

Study Record Dates

• First Submitted: November 3, 2015
• First Posted: November 16, 2015
• Study Start: November 1, 2015
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): January 1, 2030
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)