A private board in Montana conditionally approved its first experimental treatment protocol

A private board in Montana conditionally approved its first experimental treatment protocol

On August 26, Montana ETRB, a private board that reviews experimental treatment protocols, unanimously approved Parley Neurotech’s application subject to conditions. This is the first decision under Montana’s SB 535: the state licenses clinics and receives their reports, while the ETRB reviews each protocol before a patient receives treatment.

In July, Infinita launched the ETRB and began accepting applications. Now, letter RDL-2026-001 records its first decision: the board allowed one protocol to proceed, subject to conditions the applicant must meet.

SB 535 makes interventions eligible for this process after phase one clinical trials, an early assessment of safety in humans. The state licenses experimental treatment centers and receives reports of serious adverse events. For each protocol, the private ETRB reviews patient consent, alternatives, safety, and the balance between risks and expected benefits.

Parley proposed a four-week course combining the antihistamine clemastine with specially calibrated sound delivered through headphones to address age-related impairment in the brain’s processing of sound. The board required revisions to the informed consent document, provisions allowing the physician to order an ECG, a physical examination, and laboratory tests, and assessments of risks to the heart, kidneys, liver, and blood parameters, as well as the risk of falls. Once compliance with these conditions has been confirmed in writing, the protocol may be used only at a state-licensed center that has appointed this ETRB.

The ClinicalTrials.gov registry lists the same protocol as a randomized, double-blind phase 1/2a trial with four groups that is recruiting participants. In this trial, participants, treating clinicians, investigators, and assessors do not know which group a participant has been assigned to.

Business Insider reports that the ETRB is run by the private company Infinita City. The board’s chair, Matt Kaeberlein, also serves on the board of directors of the Alliance for Longevity Initiatives (A4LI). According to the publication, A4LI and Infinita founder Niklas Anzinger helped draft SB 535. Montana’s rules prohibit ETRB members from having a personal, financial, employment, or ownership interest in the center the board serves. The RDL states that members reaffirmed their conflict-of-interest declarations at the meeting.