Evaluating a new PET tracer for diagnosing dementia
First-in-Human Evaluation of an Astrocytic Glutamate Transporter (EAAT2) PET Tracer in the Brains of Healthy Controls and Patients With Dementia.
This study is testing a new imaging agent to see if it can help doctors diagnose Alzheimer's and frontotemporal dementia earlier by spotting changes in the brain.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 102 (estimated) |
| Ages | 40 Years to 75 Years |
| Sex | All |
| Sponsor | University of California, San Francisco Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (San Francisco, California) |
| Trial ID | NCT05374278 on ClinicalTrials.gov |
What this trial studies
This study assesses the safety and diagnostic performance of a novel PET agent, [18F]RP-115, designed to identify early brain changes in patients with Alzheimer's disease and frontotemporal dementia. By utilizing quantitative PET imaging, the study aims to detect regionally specific alterations in astrocytic glutamate transporters, which are crucial for maintaining brain function. The goal is to improve early diagnosis and treatment development for these neurodegenerative conditions, addressing a significant unmet need in dementia care.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 40-75 who are experiencing cognitive decline and have a study partner to provide support and information.
Not a fit: Patients with significant physical disorders or those currently taking CNS prescription drugs may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to earlier and more accurate diagnoses of Alzheimer's disease and frontotemporal dementia, ultimately improving patient outcomes.
How similar studies have performed: While this approach is novel, previous studies have shown promise in using PET imaging for neurodegenerative conditions, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age 40-75 2. Age-suitable BMI 3. Ability to provide written informed consent and willingly comply with protocol requirements or has a legal authorized representative/guardian who provides surrogate informed consent. 4. No apparent physical disorder. 5. Radial, ulnar, or brachial artery suitable for catheterization. 6. Non-smoker, and not taking OTC nicotine cessation - to limit peripheral metabolism events. 7. Devoid of CNS prescription drugs for three weeks - to limit peripheral metabolism events. For Cohort 2B and 2C: 8. Must have a study partner (informant) who spends a minimum average of 5 hours per week with the participant (e.g. family member, significant other, friend, caregiver), is generally aware of the participant's daily activities, can provide information about the participant's cognitive and functional performance, and will accompany the participant in all study procedure. 9. Recent (within 6 mo.) MME clinical scores. Exclusion Criteria: 1. Unable to provide written informed consent and unwilling to comply with protocol requirements, or does not have a legal authorized representative/guardian who can provide surrogate informed consent. 2. Inadequate arterial access. 3. Receipt of radioisotope \< 5 half-lives within \[18F\]RP-115 imaging- as to not confound any scans with radiation background for previous scanning, and unsuitable organ dosimetry thresholds from previous (\> two weeks) PET scans. 4. The performed \[18F\]RP-115 scan(s) must not represent \> 3 PET studies total within one year. 5. Contra-indication to magnetic resonance, including permanent pacemaker, implantable metallic device, etc.; or severe claustrophobia. 6. Participants who are pregnant (female patients of childbearing age will be tested prior to injection of tracer- positive test excludes from the study) 7. Participants who are breast-feeding. 8. Have a medical condition or other circumstances that in the opinion of the project physicians would significantly decrease chances of obtaining reliable data, achieving the study objective or completing the study.
Where this trial is running
San Francisco, California
- China Basin, UCSF — San Francisco, California, United States (Recruiting)
Study contacts
- Principal investigator: David Wilson, MD, PhD — University of California, San Francisco
- Study coordinator: David Wilson, MD, PhD
- Email: david.m.wilson@ucsf.edu
- Phone: 415-514-6229
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.