Phase Ib Randomized, Double-Blind, Placebo-Controlled Trial of ACD856 in Depression, Cognitive Dysfunction, and Alzheimer's Disease

The primary objective of this study is to evaluate the **safety** and **tolerability** of single and multiple doses of ACD856 in healthy participants. This is clinically relevant as it provides foundational data on the potential adverse effects and overall acceptability of ACD856, which is crucial for its future development as a therapeutic agent. The study also aims to assess the **pharmacokinetics** and **pharmacodynamics** of ACD856, which are essential for understanding the drug's absorption, distribution, metabolism, and excretion, as well as its biological effects. These evaluations are particularly significant in the context of conditions such as **depression**, **cognitive dysfunction**, and **Alzheimer’s disease**, where new therapeutic options are needed.

The clinical trial involves participants diagnosed with **depression**, **cognitive dysfunction**, and **Alzheimer's disease**. The study population includes both male and female subjects, with an age range that encompasses adults and older adults. The trial does not specifically target a vulnerable population. The sponsor has not provided information regarding the total number of participants or specific lifestyle considerations such as diet, physical activity, or habits. Additionally, key inclusion or exclusion criteria have not been disclosed by the sponsor.

The clinical trial is designed as a **randomized**, **double-blind**, **placebo-controlled** phase Ib study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple doses of ACD856 in healthy participants. The trial will focus on conditions such as **depression**, **cognitive dysfunction**, and **Alzheimer’s disease**. The estimated recruitment start date is October 24, 2025, with an anticipated end date of April 9, 2026, indicating an overall trial duration of approximately 18 months.

Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to assess eligibility based on predefined criteria. This initial visit will involve a comprehensive evaluation to ensure participants meet the necessary health standards for trial inclusion. Following successful screening, participants will be randomly assigned to receive either the investigational product or a placebo, maintaining the double-blind nature of the study. Subsequent follow-up visits will be scheduled to monitor the participants' health, collect pharmacokinetic and pharmacodynamic data, and assess any adverse events. These visits are crucial for evaluating the safety and efficacy of the investigational product over time.

The end-of-study visit will mark the conclusion of the participant's involvement in the trial. During this visit, final assessments will be conducted to gather comprehensive data on the long-term effects of the treatment. The expected length of participant involvement will vary depending on the dosing schedule but will generally align with the overall trial timeline. Conditions that may lead to early termination from the study include the occurrence of significant adverse events, non-compliance with study protocols, or withdrawal of consent by the participant. The trial is structured to ensure rigorous data collection and analysis, contributing valuable insights into the treatment of the specified medical conditions.

The clinical trial involves the administration of an **experimental medication**. However, specific details regarding the name, pharmaceutical form, dosage, route, and frequency of administration of the experimental medication are not provided in the available data. The trial documentation does not specify whether the medication is a **paediatric formulation** or if it is classified as an **orphan drug**. Additionally, there is no information on the maximum daily dose, total dose, or treatment period for the experimental medication.

In addition to the experimental medication, the trial may include the use of **non-experimental treatments** such as standard-of-care therapy, placebo, or comparator treatments. However, the data does not provide explicit details about these treatments. Information regarding the administration, dosing schedules, and participant compliance monitoring for these non-experimental treatments is also not available.

Due to the lack of specific information in the provided data, further details about the **experimental medication** and any **non-experimental treatments** used in the study cannot be elaborated upon. The trial documentation should be consulted for comprehensive information regarding the treatments involved in this clinical trial.

The clinical trial is designed to assess efficacy in a Phase 3 study. The trial is scheduled to commence recruitment on October 24, 2025, with an estimated completion date of April 9, 2026. The efficacy assessment will be conducted through a series of predefined parameters, although specific endpoints are not detailed in the available data. The trial will follow a structured timeline to ensure systematic data collection and analysis. The methods and tools for measuring efficacy will adhere to standard clinical trial protocols, ensuring the reliability and validity of the results. The trial's design and execution will be aligned with regulatory standards to evaluate the therapeutic benefits accurately.