A Randomized, Placebo-controlled, Double-blind, Parallel group, 6 Month Study to Evaluate the Safety, Tolerability, and Potential Efficacy of Monthly Trappsol® Cyclo™ (hydroxypropyl beta cyclodextrin, HPβCD) Infusions in Patients With Early Alzheimer’s Disease

The primary objective of this study is to evaluate the **safety** and **tolerability** of Trappsol® Cyclo™ (hydroxypropyl beta cyclodextrin, HPβCD) over a 24-week period in patients diagnosed with Early Alzheimer's Disease. This is clinically relevant as it aims to ensure that the treatment does not pose undue risk to patients and is well-tolerated, which is crucial for any potential therapeutic intervention. Additionally, the study seeks to explore the potential **efficacy** of Trappsol Cyclo in this patient population, which could provide insights into its therapeutic benefits. Another primary objective is to determine the **pharmacokinetics** of Trappsol Cyclo, which involves understanding how the drug is absorbed, distributed, metabolized, and excreted in the body over the 24-week period. These objectives are critical for assessing the overall viability of Trappsol Cyclo as a treatment option for Early Alzheimer's Disease.

The clinical trial involves a total of **30 participants** diagnosed with **Early Alzheimer's Disease**. The study population comprises both male and female subjects, aged between 50 to 80 years. Participants were selected based on specific inclusion criteria, including having at least an eighth-grade education and, for United States-based patients, proficiency in English to ensure the adequate completion of study procedures. The trial does not specify any particular lifestyle considerations such as diet or physical activity. The population includes individuals classified as a vulnerable group, indicating a need for careful ethical considerations during the study. The trial aims to assess the safety, tolerability, and potential efficacy of Trappsol Cyclo over a 24-week period in this demographic.

The clinical trial is designed as a **randomized**, **placebo-controlled**, **double-blind**, parallel-group study to evaluate the safety, tolerability, and potential efficacy of monthly infusions of Trappsol Cyclo, containing **hydroxypropylbetadex**, in patients with early Alzheimer's disease. The trial will span a duration of six months, with the primary objectives being the assessment of safety and tolerability, exploration of potential efficacy, and determination of pharmacokinetics over a 24-week period. Participants will be randomly assigned to receive either the active treatment or a placebo, with neither the participants nor the investigators aware of the group assignments, ensuring the double-blind nature of the study.

The sequence of study visits includes an initial screening visit to determine eligibility based on specific inclusion criteria, such as age between 50 to 80 years and a diagnosis of mild cognitive impairment due to Alzheimer's disease. Following successful screening, participants will undergo monthly visits for the administration of the infusion and assessment of safety parameters, including the incidence and severity of treatment-emergent adverse events, adverse events of special interest, vital signs, and clinical laboratory values. The end-of-study visit will occur at the conclusion of the six-month period, where final evaluations will be conducted to assess the overall outcomes of the trial.

Participant involvement is expected to last for the entire six-month duration of the trial, with conditions for early termination including the occurrence of significant adverse events or withdrawal of consent. The trial is structured to ensure rigorous monitoring and adherence to protocol, with the primary endpoints focusing on safety and pharmacokinetic measures. The study aims to provide valuable insights into the potential benefits and risks associated with the use of Trappsol Cyclo in the treatment of early Alzheimer's disease.

The clinical trial involves the administration of **Trappsol Cyclo**, an experimental medication containing the active substance **hydroxypropylbetadex**. This compound is chemically derived and is provided in the form of a **solution for infusion**. The medication is administered intravenously, with a maximum daily dose of 1000 mg/kg and a total maximum dose of 7000 mg/kg over the course of the study. The treatment period extends up to 24 weeks, with infusions occurring monthly. The primary objective is to assess the safety, tolerability, and potential efficacy of Trappsol Cyclo in patients with early Alzheimer's disease. Compliance with the dosing schedule is monitored throughout the trial to ensure adherence to the protocol.

In addition to the experimental treatment, a **sodium chloride 0.45% solution for infusion** is used as a placebo comparator in the study. This solution serves as a control to evaluate the effects of the experimental medication against a standard infusion solution. The sodium chloride solution is administered in a similar manner to the experimental treatment, ensuring that the study remains double-blind and placebo-controlled. The use of this comparator allows for a rigorous assessment of the experimental treatment's safety and efficacy in comparison to a standard infusion solution.

The efficacy of Trappsol Cyclo in patients with early Alzheimer's disease will be assessed over a 24-week period. The primary endpoints focus on safety and pharmacokinetic parameters, as detailed in the study protocol. These include the incidence and severity of treatment-emergent adverse events (TEAEs), adverse events of special interest (AESIs) such as MRI assessments of amyloid-related imaging abnormalities (ARIA-H or ARIA-E), hearing loss based on audiological examinations, and infusion reactions. Additionally, vital signs, physical examinations, and safety clinical laboratory values, including hematology, clinical chemistry, and urinalysis, will be monitored. The study is designed as a randomized, placebo-controlled, double-blind, parallel-group trial, with monthly infusions of Trappsol Cyclo administered to evaluate its potential efficacy in this patient population.