drugset / 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 50 enrolled Duke University Temple University · collab
RandomizedParallel-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2024-06-12
Primary completion
2025-05-22
Completion
2025-06-24

Drugs

EvaluationDrugModalityDoseRoute
Subject Astaxanthin Small molecule
Subject Melatonin Small molecule
Subject MitoQ Small molecule Oral
Subject Protandim Unknown Oral