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Study of 18F-OP-801 for Neuroinflammation in ALS, AD, MS, and PD

This study is looking at the safety and how the body handles a substance called 18F-OP-801. This substance is designed to help doctors see activated microglia and macrophages (types of immune cells that play a role in inflammation) in the brain using a special scan called a PET scan. Researchers believe these cells are important in conditions like Amyotrophic Lateral Sclerosis (ALS), Alzheimer's Disease (AD), Multiple Sclerosis (MS), and Parkinson's Disease (PD). The study will include people aged 18 to 80 with these conditions, as well as healthy volunteers. The main goal is to see how safe 18F-OP-801 is and what side effects it might cause over about two to four weeks. The current status of this study is unclear, and it plans to enroll 65 participants.

Study design
This is an interventional study, meaning participants will receive 18F-OP-801. It plans to enroll 65 participants, including those with ALS, AD, MS, PD, and healthy volunteers.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be monitored for safety and tolerability from Day 1 to Day 15, or Day 18-29 after receiving 18F-OP-801.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05395624

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

Recruiting
PHASE1Ages 18–80InterventionalDiagnostic
Ashvattha Therapeutics, Inc.
~65 participants
Updated 2025-05-02 on ClinicalTrials.gov
What's tested:18F-OP-801

At a glance

Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
The number of participants with treatment emergent adverse events (Safety and Tolerability)
Measured over Safety and tolerability of 18F-OP-801 as assessed by the frequency, and severity of treatment-emergent adverse events (TEAEs) from Day 1 to Day 15 or Day 18-29

Conditions

Amyotrophic Lateral Sclerosis (ALS)
Parkinson Disease (PD)
Alzheimer Disease (AD)
Multiple Sclerosis (MS)

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Where it's being run

3 sites across 2 states
California2
Florida1

Study leadership

  • Farshad Moradi, MD · PRINCIPAL_INVESTIGATOR · Stanford University

Who to contact

Julee Cheung
[email protected]
408-476-4172
Email the study team

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What this trial measures

  • The number of participants with treatment emergent adverse events (Safety and Tolerability)Safety and tolerability of 18F-OP-801 as assessed by the frequency, and severity of treatment-emergent adverse events (TEAEs) from Day 1 to Day 15 or Day 18-29

    Safety of single dose of 18F-OP-801 as measured by treatment-related adverse events as assessed by CTCAE v5.0