← Back to Search

Antioxidant

Personalized Treatments for ALS

Phase 2

Waitlist Available

Research Sponsored by Duke University

Eligibility Criteria Checklist

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

Must have

Sporadic or familial ALS diagnosed as per Gold Coast Criteria

Able to swallow tablets at enrollment and expected to be able to swallow tablets for the duration of the trial

Must not have

Prior side effects from any of the 4 investigational treatments being used in this trial

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, month 3, month 5 (2 months into treatment) and month 9 (6 months into treatment)

Awards & highlights

No Placebo-Only Group

Summary

"This trial will test a new analysis platform by GenieUs to categorize ALS patients based on their blood work into four groups: neuroinflammation, oxidative stress, impaired autophagy & ax

Who is the study for?

This trial is for individuals with Motor Neuron Disease, specifically Amyotrophic Lateral Sclerosis (ALS). Participants will be categorized based on their blood work into groups reflecting different aspects of ALS pathology and receive personalized supplements accordingly.

What is being tested?

The trial tests a platform that categorizes ALS patients into four disease categories. Depending on the category—neuroinflammation, oxidative stress, impaired autophagy & axonal transport, or mitochondrial dysfunction—participants get Astaxanthin, Protandim, Melatonin, or MitoQ respectively for 6 months.

What are the potential side effects?

Potential side effects are not detailed in the provided information. However, as dietary supplements being tested may include common reactions such as allergies to ingredients or gastrointestinal discomfort.

Eligibility Criteria

Inclusion Criteria

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

Select...

I have been diagnosed with ALS.

Select...

I can swallow tablets and will be able to do so for the trial's duration.

Exclusion Criteria

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

Select...

I have experienced side effects from previous treatments in this trial.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, month 3, month 5 (2 months into treatment) and month 9 (6 months into treatment)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, month 3, month 5 (2 months into treatment) and month 9 (6 months into treatment)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, month 3, month 5 (2 months into treatment) and month 9 (6 months into treatment) for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

ALS Functional Rating Scale, Revised (ALSFRS-R)

Secondary study objectives

Impaired autophagy measured by Beclin-1

Mitochondrial dysfunction measured by lactate.

Neurofilament Light Chain levels

+5 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

4Treatment groups

Experimental Treatment

Group I: Oxidative StressExperimental Treatment1 Intervention

Study participants in this category are expected to have too many damaging "free radical" chemicals in their brains and spinal cords.

Group II: NeuroinflammationExperimental Treatment1 Intervention

Study participants in this category are expected to have inflammation in their brains and spinal cords.

Group III: Mitochondrial DysfunctionExperimental Treatment1 Intervention

Study participants in this category are expected to have motor neurons that are unable to produce normal amounts of energy.

Group IV: Impaired Autophagy and Axonal TransportExperimental Treatment1 Intervention

Study participants in this category are expected to have motor neurons that have trouble transporting materials up and down their length, and/or trouble with the turnover of damaged proteins and intracellular structures.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

MitoQ

2006

Completed Phase 2

~250

Astaxanthin

2014

Completed Phase 3

~430