Examining tau protein in patients with language and behavioral issues
Assessment of Hyperphosphorylated Tau PET Binding in Primary Progressive Aphasia and FTD
This study is testing if a special brain imaging drug can help show how much tau protein is in the brains of people with language and behavior problems caused by conditions like Primary Progressive Aphasia and Frontotemporal Dementia.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT02736695 on ClinicalTrials.gov |
What this trial studies
This study aims to investigate the tau protein burden in the brains of patients diagnosed with Primary Progressive Aphasia (PPA) and Frontotemporal Dementia (FTD). It focuses on understanding the binding characteristics of the tau-binding drug AV-1451, which has not been previously studied in this context. By analyzing tau deposition through neuroimaging, the research seeks to establish whether AV-1451 can serve as a reliable biomarker for these neurodegenerative conditions. The study includes patients who exhibit progressive speech and language impairments or behavioral changes, ensuring a comprehensive evaluation of tau's role in these disorders.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 who have been diagnosed with Primary Progressive Aphasia or Frontotemporal Dementia and can communicate in English.
Not a fit: Patients with concurrent illnesses that could explain their speech and language deficits or those with other neurodegenerative diseases will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic tools for identifying tau-related neurodegenerative diseases, enhancing patient management.
How similar studies have performed: While this approach to studying tau in PPA is novel, similar studies have shown promise in other neurodegenerative diseases, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Must be over the age of 18 * Must speak English as your primary language * Must have an informant who can provide independent evaluation of functioning * Must present with a chief complaint of progressive impairment of speech/language or changes in behavior * Must fulfill diagnostic criteria for Primary Progressive Aphasia or Frontotemporal Dementia Exclusion Criteria: * Any subject who is mute or whose speech is unintelligible will be excluded * All subjects with concurrent illnesses that could account for speech and language deficits, such as traumatic brain injury, strokes or developmental syndromes, and subjects meeting criteria for another neurodegenerative disease, such as amnestic Alzheimer's type dementia, dementia with Lewy bodies, progressive supranuclear palsy, and corticobasal syndrome will be excluded * All pregnant, post-partum and breast-feeding women will be excluded * Subjects will also be excluded if MRI is contraindicated (metal in head, cardiac pace maker, etc.), if there is severe claustrophobia, if there are conditions that may confound brain imaging studies (e.g. structural abnormalities, including subdural hematoma or intracranial neoplasm), or if they are medically unstable or are on medications that might affect brain structure or metabolism,(e.g. chemotherapy).
Where this trial is running
Rochester, Minnesota
- Mayo Clinic — Rochester, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Keith A Josephs, M.D. — 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.