Access to CNM-Au8 for people with ALS
Intermediate-sized Expanded Access Protocol for CNM-Au8 in Amyotrophic Lateral Sclerosis (ALS).
['FUNDING_U01'] · NEW YORK UNIVERSITY SCHOOL OF MEDICINE · NIH-11405390
This program offers people with ALS access to CNM-Au8, an experimental oral therapy that aims to protect motor neurons and support cellular energy.
Quick facts
| Phase | ['FUNDING_U01'] |
|---|---|
| Study type | Nih_funding |
| Sex | All |
| Sponsor | NEW YORK UNIVERSITY SCHOOL OF MEDICINE (nih funded) |
| Locations | 1 site (NEW YORK, UNITED STATES) |
| Trial ID | NIH-11405390 on ClinicalTrials.gov |
What this research studies
If you have ALS, this expanded-access program is designed to provide CNM-Au8 across the United States, including remote and rural areas. The partners (Columbia University, Clene, and Synapticure) will run an intermediate-sized protocol to ship and manage treatment outside a traditional randomized trial. CNM-Au8 is an oral suspension of gold nanocrystals that has shown in lab models the potential to raise energy metabolites like NAD and ATP and protect neurons. Earlier Phase 2 trials and open-label extensions have explored safety and signals of benefit, and this program aims to broaden patient access while following protocol eligibility and safety monitoring.
Who could benefit from this research
Good fit: Adults diagnosed with ALS who meet the protocol's eligibility criteria and seek access to CNM-Au8, including those not enrolled in ongoing clinical trials, are the intended participants.
Not a fit: People with medical contraindications to CNM-Au8, advanced organ failure, or who expect an immediate cure may not experience benefit from this treatment.
Why it matters
Potential benefit: If helpful, CNM-Au8 could preserve motor neuron function and slow functional decline in people with ALS.
How similar studies have performed: Preclinical studies showed neuroprotective effects and two Phase 2 randomized trials with open-label extensions have evaluated CNM-Au8's safety and potential signals, but definitive clinical benefit has not been proven.
Where this research is happening
NEW YORK, UNITED STATES
- NEW YORK UNIVERSITY SCHOOL OF MEDICINE — NEW YORK, UNITED STATES (ACTIVE)
Researchers
- Principal investigator: ANDREWS, JINSY — NEW YORK UNIVERSITY SCHOOL OF MEDICINE
- Study coordinator: ANDREWS, JINSY
About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page below.
Conditions: Amyotrophic Lateral Sclerosis Motor Neuron Disease