A Molecular Anatomic Imaging Analysis of Tau in Progressive Supranuclear Palsy
Primary Purpose
Progressive Supranuclear Palsy
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
F-18 AV 1451
Sponsored by
About this trial
This is an interventional diagnostic trial for Progressive Supranuclear Palsy focused on measuring PSP
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.
Sites / Locations
- Mayo ClinicRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Tau PET Scan, F-18 AV 1451
Arm Description
All subjects will received a Tau PET scan.
Outcomes
Primary Outcome Measures
The investigators will be looking at the amount of Tau protein in the brain of patients with PSP.
Secondary Outcome Measures
Rates of change in tau-PET burden over time.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02605785
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 2015 (undefined)
Primary Completion Date
November 2025 (Anticipated)
Study Completion Date
November 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study is designed to learn more about overall tau burden in the brain of patients with Progressive Supranuclear Palsy (PSP).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Progressive Supranuclear Palsy
Keywords
PSP
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
332 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Tau PET Scan, F-18 AV 1451
Arm Type
Experimental
Arm Description
All subjects will received a Tau PET scan.
Intervention Type
Drug
Intervention Name(s)
F-18 AV 1451
Other Intervention Name(s)
Tau binding agent
Intervention Description
Tau PET scan
Primary Outcome Measure Information:
Title
The investigators will be looking at the amount of Tau protein in the brain of patients with PSP.
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Rates of change in tau-PET burden over time.
Time Frame
baseline, 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sarah M Boland, CCRP
Phone
507-284-3863
Email
boland.sarah@mayo.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer Whitwell, PhD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah M Boland, CCRP
Phone
507-284-3863
Email
boland.sarah@mayo.edu
12. IPD Sharing Statement
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
A Molecular Anatomic Imaging Analysis of Tau in Progressive Supranuclear Palsy
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