First-in-Human Evaluation of an Astrocytic Glutamate Transporter (EAAT2) PET Tracer in the Brains of Healthy Controls and Patients With Dementia.

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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's disease (AD) and frontotemporal dementia (FTD).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 75
Healthy Volunteers: t
View:

• Age 40-75

• Age-suitable BMI

• Ability to provide written informed consent and willingly comply with protocol requirements or has a legal authorized representative/guardian who provides surrogate informed consent.

• No apparent physical disorder.

• Radial, ulnar, or brachial artery suitable for catheterization.

• Non-smoker, and not taking OTC nicotine cessation - to limit peripheral metabolism events.

• Devoid of CNS prescription drugs for three weeks - to limit peripheral metabolism events.

• For Cohort 2B and 2C:

• 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.

• Recent (within 6 mo.) MME clinical scores.

Locations
United States
California
China Basin, UCSF
RECRUITING
San Francisco
Contact Information
Primary
David Wilson, MD, PhD
david.m.wilson@ucsf.edu
415-514-6229
Backup
Henry Vanbrocklin, PhD
henry.vanbrocklin@ucsf.edu
415-353-4569
Time Frame
Start Date: 2021-11-02
Estimated Completion Date: 2027-05-31
Participants
Target number of participants: 102
Treatments
Experimental: Cohort 1 - dosimetry of [18F]RP-115 in healthy volunteers
Establish \[18F\]RP-115 safety in the clinic with male and female PET imaging.
Experimental: Cohort 2B - [18F]RP-115 in patients with AD
Comparison of \[18F\]RP-115 PET binding between AD patients and age-matched cognitively normal controls and between AD and FTD
Experimental: Cohort 2C - [18F]RP-115 in patients with FTD
Comparison of \[18F\]RP-115 PET binding between AD patients and age-matched cognitively normal controls and between AD and FTD
Experimental: Cohort 2A - [18F]RP-115 in age-matched controls
Comparison of \[18F\]RP-115 PET binding between AD patients and age-matched cognitively normal controls and between AD and FTD
Sponsors
Leads: David Wilson
Collaborators: Rio pharmaceuticals Inc.

This content was sourced from clinicaltrials.gov