First-in-human Evaluation of EAAT2 PET Tracer in Healthy and Alzheimer's Diseased Brain

• Status: Recruiting
• Trial end date: 2025-07-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a first in human study that will assess the safety and diagnostic performance of [18F]RP-115 (fluorine-18 labeled RP115), a positron emission tomography (PET) agent. This agent has the potential to identify the early changes that occur in the brains of patients with Alzheimer disease.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: David Wilson
• Collaborator: Rio pharmaceuticals Inc.

Criteria

Inclusion Criteria:

1. Age 40-75 years old

2. BMI age-suitable

3. Ability to provide written informed consent and willing to 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 over the counter nicotine cessation- to limit peripheral metabolism events

7. Devoid of central nervous system prescription drugs for three weeks- to limit peripheral metabolism events.

For Cohort 2 part B only:

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

9. Recent (within 6 mo.) mini mental examination 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.