First-in-Human Evaluation of an Astrocytic Glutamate Transporter (EAAT2) PET Tracer in Dementia

Part of paid clinical trials in San Francisco, California.

Sponsor
David Wilson
Study ID
NCT05374278
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
40 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

  • [18F]RP-115 PET/MRI or PET/CT and MRI — DRUG
    An I.V. bolus injection of up to 10 millicurie (mCi) \[18F\]RP-115 will be administered, followed by a PET/MRI scan or by a combination of PET/CT and MRI

Study Details

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).

Key Dates

Start date
Nov 2, 2021
Status verified
Apr 2025
Primary completion
Apr 3, 2027
Completion
May 31, 2027

Study Design

Enrollment
102 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • 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

Primary Outcome Measure

Safety of Administered dose [ Time Frame: A year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
China Basin, UCSFSan FranciscoCalifornia94107
David Wilson, MD, PhD
[email protected]

Find similar trials in San Francisco, CA

By condition
Alzheimer's disease
By specialty
NeurologyDementia careBrain disordersGeriatrics
By research site
China Basin, UCSF· San Francisco, CA

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