Actively Recruiting
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
Led by NeuroBiogen Co., Ltd · Updated on 2025-08-08
114
Participants Needed
8
Research Sites
125 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 50 to 85 years at the time of consent
- Diagnosis of Mild Cognitive Impairment or mild Alzheimer's disease according to 2024 NIA-AA criteria
- Clinical Dementia Rating (CDR) score between 0.5 and 1.0 with memory score at least 0.5
- Mini-Mental State Examination (MMSE) score between 21 and 30
- Amyloid-positive confirmed by PET scan
- Have a caregiver able to provide accurate cognitive and functional information
- Provided voluntary written consent to participate in the study
You will not qualify if you...
- Cognitive impairment caused by conditions other than Alzheimer's disease such as vascular dementia, infections, head trauma, or other neurological diseases
- History of alcohol or drug abuse within two years prior to screening
- Serious unstable cardiovascular diseases within 24 weeks before baseline
- Severe or active infections requiring treatment within four weeks before baseline
- History of stroke, transient ischemic attack, epilepsy, or severe head trauma within one year before screening
- Allergy or hypersensitivity to study drug components
- Clinically significant neurological diseases or abnormal brain imaging findings affecting cognition
- Uncontrolled hypertension or diabetes despite treatment
- Severe bleeding disorders or severe liver impairment
- Abnormal lab values exceeding specified limits at screening
- QTcF interval longer than 450 msecs on ECG
- Gastrointestinal diseases affecting drug absorption or safety
- Psychiatric conditions interfering with study participation
- Positive Columbia-Suicide Severity Rating Scale (C-SSRS) items 4 or 5
- Use of Alzheimer's disease-modifying drugs or CNS-active drugs within specified washout periods
- Use of other investigational products within specified timeframes
- Pregnant or breastfeeding women
- Fertile men or women unwilling to use effective contraception during the study
- Other conditions deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 8 locations
1
Chonnam National Unversity Hospital
Gwangju, Gwangju, South Korea, 61469
Actively Recruiting
2
Hanyang University Guri Hospital
Guri-si, Gyeonggi-do, South Korea, 11923
Actively Recruiting
3
The Catholic University of Korea St. Vincent's Hospital
Suwon, Gyeonggi-do, South Korea, 16247
Actively Recruiting
4
Ajou University Hospital
Suwon, Gyeonggi-do, South Korea, 16499
Actively Recruiting
5
Gachon University Gil Medical Center
Incheon, Incheon, South Korea, 21565
Actively Recruiting
6
Hanyang University Seoul Hospital
Seoul, Seoul, South Korea, 04763
Actively Recruiting
7
Konkuk University Medical Center
Seoul, Seoul, South Korea, 05030
Actively Recruiting
8
Asan Medical Center
Seoul, Seoul, South Korea, 05505
Actively Recruiting
Research Team
Y
Yeonsil Moon, Professor
CONTACT
D
Dayoung Kim, Professor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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