Imaging brain tau levels in Alzheimer's disease
F 18 T807 Tau PET Imaging of Alzheimer's Disease [IND# 123119] Protocol A
This study is trying to see if a special brain scan can help spot early signs of memory problems in people with and without Alzheimer's disease by looking at tau levels in the brain.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 900 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Washington University School of Medicine Academic / other |
| Locations | 1 site (St Louis, Missouri) |
| Trial ID | NCT02414347 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the correlation between brain tau fibril uptake, measured by PET imaging with the compound F 18 T807, and cognitive status in individuals with and without tau fibrils. It is a single-center, open-label baseline controlled study that will collect quantitative data to characterize tau binding in the brain. The primary goal is to explore the potential of tau imaging as an early biomarker for cognitive decline, potentially identifying changes before the onset of dementia.
Who should consider this trial
Good fit: Ideal candidates include cognitively normal individuals or those with mild dementia, aged 18 and older, who can undergo imaging procedures.
Not a fit: Patients with conditions that prevent them from tolerating imaging procedures or those with severe chronic pain may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to earlier detection of cognitive decline in Alzheimer's disease, allowing for timely interventions.
How similar studies have performed: Other studies have shown promise in using tau imaging techniques, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Male or female participants, at least 18 years of age. 2. Cognitively normal, or with mild dementia, as assessed clinically 3. Participant is able and willing to undergo testing (MRI or CT, PET, radioactive tracer injection, LP; for those unable to undergo an MRI, CT will be used to generate regions-of-interest). 4. Pre-menopausal women will undergo a urine pregnancy test within 24 hours of drug administration. Exclusion Criteria: 1. Has any condition that, in the Investigator's opinion, could increase risk to the participant, limit the participant's ability to tolerate the experimental procedures, or interfere with the collection/analysis of the data (for example, participants with severe chronic back pain might not be able to lie still during the scanning procedures). 2. Is deemed likely unable to perform the imaging procedures for any reason. 3. Has a high risk for Torsades de Pointes or is taking medications known to prolong QT interval. 4. Has hypersensitivity to F 18 T807 or any of its excipients. 5. Contraindications to PET, PET-CT or MR (e.g. electronic medical devices, inability to lie still for long periods) that make it unsafe for the individual to participate. 6. Severe claustrophobia. 7. Currently pregnant or breast-feeding. 8. For those electing to undergo the optional lumbar puncture: currently on anticoagulant of any form -
Where this trial is running
St Louis, Missouri
- Washington University School of Medicine — St Louis, Missouri, United States (Recruiting)
Study contacts
- Principal investigator: Tammie Benzinger, MD, PhD — Washington University School of Medicine
- Study coordinator: Kelley M Jackson, BA
- Email: kelleyj@wustl.edu
- Phone: 314 362-1558
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.