NCT06429059CompletedPhase 2
ROAR-DIGAP: A Widely Inclusive, Largely Virtual Pilot Trial Utilizing DIGAP (Deep Integrated Genomics Analysis Platform) To Personalize Treatments
Source: ClinicalTrials.gov · Last updated 27 Oct 2026
Brief summary (registry, in English)
GenieUs developed an analysis platform that will be tested to separate study participants with ALS into four categories based on blood work. These general categories are neuroinflammation, oxidative stress, impaired autophagy \& axonal transport, and mitochondrial dysfunction. Once a disease category is established, participants in this study will receive one of four individualized supplements for 6 months and we will determine whether these are slowing ALS progression: Astaxanthin will be given for the category of neuroinflammation, Protandim for oxidative stress, Melatonin for impaired autophagy and MitoQ for mitochondrial dysfunction. During the first 3 months, participants will have routine monitoring and in months 3 through 9 they will receive the assigned supplement.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 50 (actual)
- First submitted
- 9 Apr 2024
- Start date
- 12 Jun 2024
- Primary completion date
- 22 May 2025
- Lead sponsor
- Duke University
- Diseases
- ALS (motor neurone disease)
- NCT number
- NCT06429059
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 50
- From 12 Jun 2024 to the primary completion date, 22 May 2025
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior side effects from any of the 4 investigational treatments being used in this trial.
Other illness
- 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.
Other
- Actively or recently (within past 30 days) participating in another intervention trial.
- Currently or recently (within 30 days) taking any of the 4 investigational treatments being used in this trial.
- Pregnant women or women currently breastfeeding.
- Life expectancy shorter than the duration of the trial.
Who the study is looking for
- Male or female aged at least 18 years.
- Sporadic or familial ALS diagnosed as per Gold Coast Criteria.
- Patient is able to understand and express informed consent (in the opinion of the site investigator).
- Patient is able to read and write English.
- Patient is expected to survive for the duration of the trial.
- Able to swallow tablets at enrollment and expected to be able to swallow tablets for the duration of the trial.
- 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)
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Duke University Medical Center Coordinator of this site? Confirm its status | Durham | United States | Unknown status |
| Temple University Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.