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NCT05374278

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

Recruiting now Phase 1, PHASE2 Last updated 17 April 2025
What this trial tests

Phase 1, PHASE2 trial testing [18F]RP-115 PET/MRI or PET/CT and MRI in Alzheimer Disease in 102 participants. Currently enrolling.

Timeline
2 November 2021
Primary endpoint
3 April 2027
31 May 2027

Quick facts

Lead sponsorDavid Wilson
PhasePhase 1, PHASE2
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationnon randomized
Designparallel
Maskingnone
Primary purposediagnostic
Enrollment102
Start date2 November 2021
Primary completion3 April 2027
Estimated completion31 May 2027
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

David Wilson — full company profile →

Who can join

Adults 40 to 75, any sex, with Alzheimer Disease or Frontotemporal Dementia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. A Medicinal Chemistry Perspective on Excitatory Amino Acid Transporter 2 Dysfunction in Neurodegenerative Diseases.
    Fontana IC, Souza DG, Souza DO, Gee A, et al · · 2023 · cited 23× · PMID 36787643 · DOI 10.1021/acs.jmedchem.2c01572
  2. Activity and Heterogeneity of Astrocytes in Neurological Diseases: Molecular Mechanisms and Therapeutic Targets.
    Mao S, Qiao R, Wang Q, Shen L, et al · · 2025 · cited 1× · PMID 40859959 · DOI 10.1002/mco2.70329
  3. First-in-human healthy volunteer dosimetry studies of the excitatory amino acid transporter 2 (EAAT2) PET imaging tracer methyl N<sup>4</sup>-(7-[<sup>18</sup>F]fluoro-9H-fluoren-2-yl)asparaginate, [<sup>18</sup>F]RP-115.
    Chao CK, Blecha J, Polvoy I, Nillo RM, et al · · 2025 · cited 1× · PMID 39913962 · DOI 10.1016/j.nucmedbio.2025.108992

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