Clinical Trial

Safety, PK and Biodistribution of 18F-OP-801 in Patients With ALS, AD, MS, PD and Healthy Volunteers

Recruiting Phase 1/2
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Record status
This record was last updated May 2, 2025 (before its estimated January 1, 2026 completion). Its status may not reflect the trial's current state.
Summary
This is a Phase 1/2 study to evaluate the safety and tolerability of 18F-OP-801 in subjects with ALS, AD, MS, PD and age-matched HVs. 18F-OP-801 is intended as a biomarker for PET imaging of activated microglia and macrophages in regions of neuroinflammation.
Protocol Amendment History 5 amendments
This ClinicalTrials.gov record has been amended 5 times since 2022-05-25; most recent amendment 2025-04-30.
Status change: Not Yet Recruiting → Recruiting 2023-02-09
Trial Details
NCT Number NCT05395624
Lead Sponsor Ashvattha Therapeutics, Inc.
Conditions Amyotrophic Lateral Sclerosis (ALS), Parkinson Disease (PD), Alzheimer Disease (AD), Multiple Sclerosis (MS)
Enrollment 65 participants
Start Date 2023-02-02
Primary Completion 2026-01-01 (estimated)
Study Completion 2026-05-01 (estimated)
Updated on ClinicalTrials.gov 2025-05-02