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RecruitingPhase 2NCT07027072

Study to Evaluate the Efficacy and Safety of KDS2010 in Patients With Alzheimer's Disease With Mild Cognitive Impairment and Mild Dementia Due to Alzheimer's Disease

A Randomized, Double-Blind, Placebo-Controlled, Dose-Finding, Phase 2a Clinical Trial to Evaluate the Efficacy and Safety of KDS2010 in Patients With Alzheimer's Disease With Mild Cognitive Impairment and Mild Dementia Due to Alzheimer's Disease

Sponsor

NeuroBiogen Co., Ltd

Enrollment

114 participants

Start Date

Aug 6, 2025

Study Type

INTERVENTIONAL

Conditions

Mild Cognitive Impairment (MCI)Mild DementiaAlzheimer's Disease

Summary

A randomized, double-blind, placebo-controlled, dose-finding Phase 2a clinical trial will be conducted to evaluate the efficacy and safety of KDS2010 in patients with Mild Cognitive Impairment (MCI) due to Alzheimer's disease (AD) and mild dementia due to Alzheimer's disease. Based on preliminary efficacy observed in the Phase 1 clinical trial, a multinational study will be conducted in both Korea and the United States. Eligible patients diagnosed with MCI or mild Alzheimer's disease will be stratified by disease stage (MCI/mild AD) and geographic region (Korea/USA) prior to randomization. Subjects will be randomly assigned in a 1:1:1 ratio to either Treatment Group 1, Treatment Group 2, or the Control Group. The investigational product will be administered orally once daily for a duration of 24 weeks. Approximately 114 subjects will be enrolled, including an estimated 20% dropout rate, with 38 subjects assigned to each group (Treatment Group 1, Treatment Group 2, and Control Group). The objectives of the study are as follows: 1. Efficacy Objectives: Efficacy will be evaluated through changes in cognitive function, self-management, and daily living activities before and after administration of KDS2010. Biomarker analysis in plasma and in cerebrospinal fluid (CSF; optional) will also be conducted to explore treatment efficacy. 2. Safety Objectives: The safety and tolerability will be evaluated after administration of KDS2010. 3. Exploratory Objectives: The efficacy of Treatment Groups 1 and 2 compared to the Control group will be explored through cognitive endpoints (the Clinical Dementia Rating-Sum of Boxes (CDR-SB), the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog13), and the Mini-Mental State Examination (MMSE)), stratified by demographic information, tauopathy, and ApoE4 genes. Based on nonclinical and Phase 1 clinical data, KDS2010 will be administered orally once daily at two dose levels: 60 mg and 120 mg.

Eligibility

Min Age: 50 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a new drug called KDS2010 can slow down memory and thinking problems in people with early-stage Alzheimer's disease. **You may be eligible if:** - You are between 50 and 85 years old - You have been diagnosed with mild cognitive impairment or mild Alzheimer's disease - A brain scan (PET scan) has confirmed the presence of amyloid plaques (a hallmark of Alzheimer's) - Your memory test scores fall within a specific range indicating mild impairment - You have a caregiver who can reliably report on your daily functioning **You may NOT be eligible if:** - You have moderate or severe Alzheimer's disease - You have another form of dementia or significant brain disease - You have an uncontrolled serious medical condition - You have had a stroke, brain tumor, or serious head injury Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGKDS2010

KDS2010 will be administered orally once daily, two tablets per day, for 24 weeks. Dosage will be either 60 mg or 120 mg depending on the assigned group.

DRUGPlacebo

Placebo matching the investigational product in appearance but containing no active ingredient, administered orally once daily, two tablets per day, for 24 weeks.

Locations(8)

Chonnam National Unversity Hospital

Gwangju, Gwangju, South Korea

Hanyang University Guri Hospital

Guri-si, Gyeonggi-do, South Korea

The Catholic University of Korea St. Vincent's Hospital

Suwon, Gyeonggi-do, South Korea

Ajou University Hospital

Suwon, Gyeonggi-do, South Korea

Gachon University Gil Medical Center

Incheon, Incheon, South Korea

Hanyang University Seoul Hospital

Seoul, Seoul, South Korea

Konkuk University Medical Center

Seoul, Seoul, South Korea

Asan Medical Center

Seoul, Seoul, South Korea

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NCT07027072

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