Cyclo Therapeutics, Inc. announced the first patient has been enrolled and dosed in its Phase 2b study of Trappsol® Cyclo™ for the treatment of early Alzheimer's disease (AD), targeting the disrupted lipid pathways and the reduction of amyloid beta and tau. The Phase 2b study is a U.S. multicenter, randomized, placebo-controlled, double-blind, parallel group, 6-month study evaluating the safety, tolerability, and potential efficacy of monthly Trappsol® Cyclo™ infusions in patients with early Alzheimer's disease. The study will enroll approximately 120 patients who have shown evidence of progressive cognitive decline in the last year as determined by serial cognitive test scores, if available, or patient or informant/caregiver/study partner report as documented by the Investigator.

Enrolled patients will be randomized across three study arms: 500 mg/kg or 1,000 mg/kg of Trappsol® Cyclo™ and placebo. The study will consist of a screening period, treatment period up to 24 weeks, and a safety follow-up period. Trappsol® Cyclo™ is the Company's proprietary formulation of hydroxypropyl beta cyclodextrin, and in multiple clinical studies, has shown encouraging results to effectively manage the transportation of cholesterol, a known defect in neurodegenerative diseases.

Many of the known risk factors for Alzheimer's disease are associated with cholesterol metabolism. Cyclo Therapeutics is currently testing the same investigational Trappsol® Cyclo™ drug in a Phase 3 clinical trial (TransportNPC™) and a long-term extension study for the treatment of Niemann-Pick disease Type C1, a rare, fatal and progressive genetic disorder. Taking the place of the defective NPC1 protein, Trappsol® Cyclo™, with its cyclic structure, facilitates the transport of accumulated cholesterol out of cellular lysosomes so it can be further processed and excreted out of cells.

With the biologic similarities demonstrated between Niemann-Pick disease Type C1 and Alzheimer's disease, including cholesterol accumulation in regions of the brain, promoted levels of Tau in cerebrospinal fluid (‘CSF'), and amyloid plaques in the brain, the Company believes Trappsol® Cyclo™ has significant potential to be an effective treatment option for Alzheimer's disease.