Analyzing tau levels in the brain of patients with Progressive Supranuclear Palsy
A Molecular Anatomic Imaging Analysis of Tau in Progressive Supranuclear Palsy
This study is testing a special imaging tool to see how much tau protein builds up in the brains of people with Progressive Supranuclear Palsy to help understand the condition better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 332 (estimated) |
| Ages | 35 Years and up |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT02605785 on ClinicalTrials.gov |
What this trial studies
This study aims to investigate the overall tau burden in the brains of patients diagnosed with Progressive Supranuclear Palsy (PSP). Participants will receive an intervention involving F-18 AV 1451, a tracer used in molecular imaging to visualize tau protein accumulation. The study will include individuals over 35 years of age who exhibit gradual progression of PSP-related symptoms and have a reliable informant to provide additional information. The goal is to enhance understanding of tau pathology in PSP, which may inform future therapeutic strategies.
Who should consider this trial
Good fit: Ideal candidates are individuals over 35 years old with a diagnosis of Progressive Supranuclear Palsy and a reliable informant.
Not a fit: Patients with other neurodegenerative diseases such as Alzheimer's or frontotemporal dementia will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic and therapeutic approaches for patients with Progressive Supranuclear Palsy.
How similar studies have performed: Other studies have shown success in using molecular imaging techniques to analyze tau in various neurodegenerative conditions, suggesting potential for this approach in PSP.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Rochester, Minnesota
- Mayo Clinic — Rochester, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Jennifer Whitwell, PhD — Mayo Clinic
- Study coordinator: Sarah M Boland, CCRP
- Email: boland.sarah@mayo.edu
- Phone: 507-284-3863
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.