Evaluating a new PET tracer for diagnosing dementia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.