Brief Title
A Molecular Anatomic Imaging Analysis of Tau in Progressive Supranuclear Palsy
Official Title
A Molecular Anatomic Imaging Analysis of Tau in Progressive Supranuclear Palsy
Brief Summary
This study is designed to learn more about overall tau burden in the brain of patients with
Progressive Supranuclear Palsy (PSP).
Study Type
Interventional
Primary Outcome
The investigators will be looking at the amount of Tau protein in the brain of patients with PSP.
Secondary Outcome
Rates of change in tau-PET burden over time.
Condition
Progressive Supranuclear Palsy
Intervention
F-18 AV 1451
Study Arms / Comparison Groups
Tau PET Scan, F-18 AV 1451
Description: All subjects will received a Tau PET scan.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
332
Start Date
November 2015
Completion Date
November 2025
Primary Completion Date
November 2025
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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.
Gender
All
Ages
35 Years - N/A
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Jennifer Whitwell, PhD, 507-284-3863, [email protected]
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT02605785
Organization ID
15-004618
Responsible Party
Principal Investigator
Study Sponsor
Mayo Clinic
Study Sponsor
Jennifer Whitwell, PhD, Principal Investigator, Mayo Clinic
Verification Date
November 2022