What side effects are associated with this type of intervention?

Common treatments for Lou Gehrig's Disease (ALS) include Riluzole and Edaravone. Riluzole can cause side effects such as nausea, weakness, decreased lung function, and liver damage. Edaravone may lead to bruising, gait disturbances, headaches, and allergic reactions. Both treatments aim to slow disease progression and manage symptoms, but they do not cure ALS.

What prior FDA approvals exist?

The FDA has approved several treatments for Lou Gehrig's Disease (ALS), including Riluzole and Edaravone. Riluzole is believed to reduce damage to motor neurons by decreasing the release of glutamate, while Edaravone is thought to act as an antioxidant, reducing oxidative stress. These treatments aim to slow disease progression and manage symptoms. While 18F-OP-801 is a biomarker for PET imaging of neuroinflammation, it is not a treatment but rather a diagnostic tool to visualize neuroinflammatory processes, which could potentially aid in the development of new therapeutic strategies targeting neuroinflammation in ALS.

What other types of research exist?

A promising alternative to 18F-OP-801 for PET imaging of neuroinflammation in Lou Gehrig's Disease (ALS) patients is [(18)F]DPA-714. This imaging agent targets TSPO, a protein linked to microglial activation, and has been used effectively in other neurological conditions to detect neuroinflammation.

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18F-OP-801 for ALS

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

Must not have

Female subjects may not be pregnant, lactating, or breastfeeding

Overall Exclusion Criteria - For All Subjects: History of recurrent kidney or liver malignancy

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

No Placebo-Only Group

Summary

This trial tests a new brain scan substance called 18F-OP-801 on patients with ALS, AD, MS, PD, and healthy volunteers. It helps doctors see brain inflammation by highlighting active immune cells. This could improve early detection and treatment of these diseases.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not pregnant, lactating, or breastfeeding.

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I have never had recurrent kidney or liver cancer.

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I do not have a diagnosis of PML.

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I haven't taken any experimental drugs in the last 30 days or 5 half-lives.

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I do not have signs of NMO or MOG-associated encephalomyelitis.

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I can lie still in a scanner for up to 90 minutes.

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I haven't taken specific pain relievers in the last 14 days.

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My Parkinson's disease is not caused by genetics or other conditions.

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I have never had a brain disorder or injury that could affect brain scans.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

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 study objectives

Correlation between plasma biomarker levels and PET signal for each participant

Evaluate timeframe for optimal CNS tracer uptake

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.