Cyclo Therapeutics has enrolled and dosed the first participant in its Phase IIb study of Trappsol Cyclo to treat early Alzheimer’s disease (AD).

The US placebo-controlled, parallel group, multicentre, double-blind, randomised, six-month study has been designed to assess the tolerability, potential efficacy, and safety of monthly infusions of Trappsol Cyclo in early AD patients.

Nearly 120 patients who have shown evidence of progressive cognitive decline in the last year will be enrolled in the trial.

In the trial, all the participants will be randomised across three study arms to receive 500mg/kg or 1000mg/kg of Trappsol Cyclo and a placebo.

It includes a screening period, a treatment period of up to 24-weeks, and a follow-up period for safety.

Cyclo Therapeutics chief medical officer Lise Kjems said: “The start of this study is a significant milestone for our company and the Alzheimer’s disease community.

“Based on the encouraging results Trappsol Cyclo has demonstrated to date, we believe we are well-positioned to address the unmet medical need that patients, families and physicians are facing.”

Trappsol Cyclo is the company’s proprietary hydroxypropyl beta cyclodextrin formulation.

It has also demonstrated encouraging results in several clinical studies in effectively managing the cholesterol transportation, which is said to be a known defect in neurodegenerative diseases.

According to the company, most of the known risk factors for AD are related to cholesterol metabolism.

At present, Cyclo Therapeutics is evaluating Trappsol Cyclo in a Phase III TransportNPC clinical trial, as well as in a long-term extension study to treat Niemann-Pick disease Type C1, which is a rare, fatal, and progressive genetic disorder.