Imaging tau protein in the brain of older adults
Tau PET Imaging in the NACC Study Cohort: Modulators of MTL Subregion Structure and Function in Normal and Pathological Aging
This study is trying to see how tau protein levels in the brains of older adults, both those who are cognitively healthy and those with Mild Cognitive Impairment, relate to memory changes over time.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 60 Years and up |
| Sex | All |
| Sponsor | University of Pennsylvania Academic / other |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Trial ID | NCT03189485 on ClinicalTrials.gov |
What this trial studies
This observational study aims to measure tau protein levels in the brains of cognitively normal older adults and those with Mild Cognitive Impairment (MCI) using a specialized PET imaging agent called 18F-AV-1451. Participants will undergo a tau PET scan at the Penn Memory Center as part of the National Alzheimer's Coordinating Center (NACC) study. The study will collect imaging data to explore the relationship between tau levels and cognitive decline, with follow-up scans planned approximately 2-3 years later. Insights gained may help distinguish between normal aging and early Alzheimer's disease.
Who should consider this trial
Good fit: Ideal candidates are cognitively normal older adults or individuals with Mild Cognitive Impairment aged 60 and above who are part of the NACC cohort.
Not a fit: Patients with significant medical or psychiatric conditions that could affect their safety or participation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of cognitive decline mechanisms and improve early detection of Alzheimer's disease.
How similar studies have performed: Other studies using tau PET imaging have shown promise in understanding Alzheimer's disease, indicating that this approach is supported by prior research.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Males and females ≥ 60 years of age. 2. Part of the NACC longitudinal cohort (Protocol #: 068200) of the PMC/ADCC with consensus conference designation of cognitively normal or MCI. 3. NACC longitudinal visit must be completed or scheduled to be completed within 6 months of the 18F-AV-1451 TAU PET scan. 4. A brain MRI must be performed within 12 months prior to their study scan date and be deemed of adequate quality that the scan may be used for study analysis, including 3T and/or 7 Tesla high-resolution imaging of medial temporal lobe structures. 5. An amyloid PET scan completed or scheduled within 12 months of their study scan date 6. Women must be post-menopausal or surgically sterile Exclusion Criteria: 1. Any medical or psychiatric conditions that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study. 2. Have evidence of structural abnormalities such as major stroke or mass on MRI that is likely to interfere with analysis of the PET scan 3. Inability to tolerate or contraindication to imaging procedures in the opinion of an investigator or treating physician 4. Have current clinically significant cardiovascular disease .Have a history of significant or ongoing alcohol abuse or substance abuse or dependence based on medical record review or self-reported
Where this trial is running
Philadelphia, Pennsylvania
- UPenn — Philadelphia, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: David Wolk, MD — University of Pennsylvania
- Study coordinator: Jackie Lane, MPH
- Email: jacqueline.lane@pennmedicine.upenn.edu
- Phone: 215-662-7057
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.