Montana’s legislature has legalized so-called “experimental treatment centers,” allowing clinics to administer FDA-unapproved therapies—ranging from peptide and gene injections to NAD+ infusions—for longevity outside the typical trial framework.
Key points
Montana law licenses clinics to administer Phase 1-only anti-aging therapies without FDA Phase 2/3 approval.
Therapies include NAD+ infusions, peptide/gene protocols targeting follistatin and klotho proteins.
Clinics must allocate 2% of profits to low-income patients, expanding access beyond terminally ill groups.
Why it matters:
By cutting regulatory delays, this law could accelerate human testing of novel longevity modalities, but raises critical safety and equity considerations.
Q&A
What is an experimental treatment center?
How does NAD+ therapy work?
What are follistatin and klotho therapies?
What regulatory phases do these treatments skip?
Are these treatments covered by insurance?
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Academy
Nicotinamide Adenine Dinucleotide (NAD+)
What is NAD+? Nicotinamide adenine dinucleotide, or NAD+, is a vital coenzyme present in all living cells. It exists in two forms—NAD+ and NADH—and shuttles electrons during redox reactions, key steps in cellular energy production.
Role in Metabolism and Aging
- Energy Metabolism: NAD+ accepts electrons in glycolysis and the Krebs cycle, converting nutrients into usable cellular energy (ATP).
- DNA Repair: NAD+ is a substrate for enzymes like PARPs (poly ADP-ribose polymerases), which repair damaged DNA and maintain genomic stability.
- Sirtuin Activation: NAD+ enables sirtuins—proteins that regulate gene expression, stress resistance, and mitochondrial function—factors linked to longevity.
Aging and NAD+ Levels NAD+ concentrations decline with age, correlating with reduced energy production, impaired DNA repair, and metabolic dysfunction. Researchers hypothesize that restoring NAD+ levels may counteract age-related cellular decline.
Experimental NAD+ Therapies
Anti-aging clinics administer NAD+ via IV drips, injections, or oral precursors (e.g., nicotinamide riboside). These treatments aim to boost systemic NAD+ levels quickly, but clinical validation remains at early safety stages. Dosing varies widely, with costs from a few hundred to several thousand dollars per session.
Benefits and Risks
- Potential Benefits: Improved energy, enhanced metabolic function, better DNA repair, and possible cognitive support.
- Safety Concerns: Short-term human trials suggest tolerability, but long-term effects are unknown. Overdosing could dysregulate metabolic pathways.
Regulatory and Ethical Considerations
Under traditional FDA pathways, NAD+ therapies must clear Phase 2/3 trials to prove efficacy. Experimental treatment centers, like those now legal in Montana, may bypass these requirements, offering early access but raising questions about patient safety, equitable distribution, and informed consent.
Future Directions
Ongoing research is focused on refining dosing regimens, developing targeted delivery systems, and conducting larger clinical studies to establish concrete health outcomes. As our understanding of NAD+ biology deepens, precise, personalized therapies may emerge, optimizing healthy aging while minimizing risks.
