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Could a simple supplement slow ALS? new trial aims to find out

NCT ID NCT06429059

Disease control Sponsor: Duke University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This completed Phase 2 pilot trial tested whether personalized supplements could slow the progression of ALS. Researchers used a genetic analysis platform to sort 50 participants into four disease categories—neuroinflammation, oxidative stress, impaired autophagy, or mitochondrial dysfunction—and gave each group a specific supplement (astaxanthin, protandim, melatonin, or MitoQ) for six months. The goal was to see if these supplements could slow decline in daily function, as measured by the ALS Functional Rating Scale.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Astaxanthin, Protandim, Melatonin, MitoQ (personalized supplements based on genetic profile)
What this could lead to
If successful, this approach could point toward a way to slow ALS progression by matching supplements to each person's specific disease type.
What could go wrong
This is a small pilot trial with only 50 participants and no placebo group, so results may not be conclusive. Supplements are not proven treatments for ALS, and individual responses may vary.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

50 people

The number who actually took part.

Started

Jun 2024

Finished

Jun 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Male or female aged at least 18 years. 2. Sporadic or familial ALS diagnosed as per Gold Coast Criteria. 3. Patient is able to understand and express informed consent (in the opinion of the site investigator). 4. Patient is able to read and write English. 5. Patient is expected to survive for the duration of the trial. 6. Able to swallow tablets at enrollment and expected to be able to swallow tablets for the duration of the trial. 7. Women must not be pregnant (will have evidence of a negative pregnancy test obtained by study team at baseline, or by local physician within past 7 days or be post-menopausal) 8. Women must not be able to become pregnant (e.g., post-menopausal, surgically sterile, or using adequate birth control methods) for the duration of the study and three months after study completion. Adequate contraception includes abstinence, hormonal contraception (oral contraception, implanted contraception, injected contraception, or other hormonal contraception, for example patch or contraceptive ring), intrauterine device (IUD) in place for ≥ 3 months, barrier method in conjunction with spermicide, or another adequate method. Exclusion Criteria: 1. Actively or recently (within past 30 days) participating in another intervention trial. 2. Currently or recently (within 30 days) taking any of the 4 investigational treatments being used in this trial. 3. Prior side effects from any of the 4 investigational treatments being used in this trial. 4. Patient has a medical or psychiatric illness that could in the investigator's opinion interfere with the patient's ability to participate in this study. 5. Pregnant women or women currently breastfeeding. 6. Life expectancy shorter than the duration of the trial.

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Conditions

The condition(s) this trial relates to.

amyotrophic lateral sclerosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Amyotrophic lateral sclerosis (ALS)

Contacts and locations

Locations

  • Duke University Medical Center

    Durham, North Carolina, 27705, United States

  • Temple University

    Philadelphia, Pennsylvania, 19122, United States

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