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18F-OP-801 for Lou Gehrig's Disease

Phase 1 & 2

Recruiting

Led By Farshad Moradi, MD

Research Sponsored by Ashvattha Therapeutics, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Inclusion Criteria Specific to MS Subjects: EDSS score between 2.0 and 5.5 inclusive at Screening

Female subjects of childbearing potential and all male subjects must agree to practice abstinence from sexual intercourse or use a medically accepted contraceptive regimen

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 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

Awards & highlights

Study Summary

This trial will study the safety and how 18F-OP-801 (18F Hydroxyl Dendrimer) behaves in the body after being given intravenously to patients with ALS and healthy volunteers.

Who is the study for?

This trial is for adults aged 18-80 with ALS, Alzheimer's, Parkinson's, or Multiple Sclerosis and healthy volunteers. Participants must have stable medication use and meet specific health criteria like normal C-reactive protein levels. Women of childbearing age must use effective contraception, as should men; women can't be pregnant or breastfeeding.Check my eligibility

What is being tested?

The study tests the safety and distribution in the body of a new PET imaging biomarker called 18F-OP-801. It aims to identify activated microglia/macrophages in areas affected by neuroinflammation in patients with neurological conditions compared to healthy individuals.See study design

What are the potential side effects?

As this is an early-phase trial primarily assessing safety and biodistribution of the imaging agent (18F-OP-801), potential side effects are not detailed but may include reactions typical to PET imaging agents such as discomfort at injection site or allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My MS disability score is between 2.0 and 5.5.

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I agree to use birth control or abstain from sex.

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I am a woman who cannot become pregnant due to surgery or menopause.

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I am between 55 and 80 years old.

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I have been diagnosed with Parkinson's disease based on specific criteria.

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My MS disability score is between 3.0 and 6.5.

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I have early-stage Alzheimer's with positive brain scans and biomarker tests.

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I have been diagnosed with ALS, either sporadic or familial.

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I am a woman who can have children and have a negative pregnancy test.

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I will use effective birth control during and after the study for the required time.

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I have been diagnosed with ALS according to the El Escorial criteria.

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I am between 18 and 80 years old.

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I am a woman who cannot have children due to surgery or being postmenopausal for 2+ years.

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I am not pregnant, breastfeeding, or lactating.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 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

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

The number of participants with treatment emergent adverse events (Safety and Tolerability)

Secondary outcome measures

Assess ability of 18F-OP-801 to detect regions of neuroinflammation in ALS, AD, MS, and PD participants

Assess test/retest imaging repeatability

Correlation between plasma NfL levels and degree of 18F-OP-801 uptake in each participant

+3 more

Other outcome measures

Correlation between plasma biomarker levels and PET signal for each participant

Evaluate timeframe for optimal CNS tracer uptake