Trial · NCT06429059
ROAR-DIGAP: A Widely Inclusive, Largely Virtual Pilot Trial Utilizing DIGAP (Deep Integrated Genomics Analysis Platform) To Personalize Treatments
NCT06429059, Phase 2, Completed, Duke University
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. ROAR-DIGAP: A Widely Inclusive, Largely Virtual Pilot Trial Utilizing DIGAP (Deep Integrated Genomics Analysis Platform) To Personalize Treatments. Trials, record NCT06429059. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06429059
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- ROAR-DIGAP: A Widely Inclusive, Largely Virtual Pilot Trial Utilizing DIGAP (Deep Integrated Genomics Analysis Platform) To Personalize Treatments
- NCT number
- NCT06429059
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 50 participants, actual
- Lead sponsor
- Duke University
- Conditions
- Amyotrophic Lateral Sclerosis ALS
- Interventions
- Astaxanthin, Protandim, Melatonin, MitoQ
- First posted
- 2024-05-24
- Last updated
- 2026-10-27
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | ALS Functional Rating Scale, Revised (ALSFRS-R) | Baseline, month 3, month 5, and month 9 | A quickly administered (five minute) ordinal rating scale (ratings 0-4) used to determine patients' assessments of their capability and independence in 12 functional activities. The total score ranges from 0 (maximum disability) to 48 (normal function). A higher score indicates greater function. |
| Secondary | Neurofilament Light Chain Levels | Baseline, month 3, month 5 (2 months into treatment) and month 9 (6 months into treatment) | Neurofilament light chain levels are elevated in the spinal fluid and the blood of patients with ALS and other neurodegenerative diseases, and higher levels predict more severe disease progression. These levels rise dramatically when asymptomatic carriers of ALS-causing genetic mutations begin to convert to an ALS phenotype. |
| Secondary | Neuroinflammation Measured by C-reactive Protein (CRP) | Baseline, 3 months, 5 months and 9 months | Used to measure neuroinflammation. CRPs are known to be abnormal in patients with ALS, their levels correlate with disease progression and they can be altered by drugs in trials. |
| Secondary | Neuroinflammation Measured by Monocyte Chemoattractant Protein-1 (MCP-1), Also Known as CCL2 | Baseline, 3 months, 5 months and 9 months | Used to measure neuroinflammation. CCL2s are known to be abnormal in patients with ALS, their levels correlate with disease progression and they can be altered by drugs in trials. |
| Secondary | Oxidative Stress Measured by Total Antioxidant Capacity (TAC) | Baseline, 3 months, 5 months, and 9 months | Used to measure oxidative stress. |
| Secondary | Oxidative Stress Measured by Uric Acid Levels. | Baseline, 3 months, 5 months, and 9 months | Uric acid is an antioxidant and levels of uric acid have been reported to be lower in ALS subjects and correlated with progression. It has also been shown to be responsive to treatments in trials |
| Secondary | Mitochondrial Dysfunction Measured by Lactate | Baseline, 3 months, 5 months, and 9 months | Compromised mitochondrial oxidative phosphorylation shifts the cellular bioenergetic system to anaerobic respiration and increases the level of lactate. Lactate has been used as a biomarker for mitochondrial disease in many previous studies. |
| Other | Impaired Autophagy Measured by Beclin-1 | Baseline, 3 months, 5 months, and 9 months | To measure impaired autophagy, we will use Beclin-1. This highly conserved eukaryotic protein has a major regulatory role in autophagy. It is a component of the phosphatidylinositol-3-kinase (PI3K) complex which mediates vesicle-trafficking thereby inducing autophagy. Beclin-1 dysfunction has been implicated in many disorders, including cancer and neurodegenerative diseases. |
| Other | Neuroinflammation Measured by Chitotriosidase (CHIT1) | Baseline, 3 months, 5 months and 9 months | Used to measure neuroinflammation. CHIT1 is known to be abnormal in patients with ALS, its levels correlate with disease progression and they can be altered by drugs in trials. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06429059
GET https://conductscience.org/api/trials/v1/NCT06429059/registered