Condition: Mild Cognitive Impairment (MCI) · Mild Dementia · Alzheimer's Disease · Sponsor: NeuroBiogen Co., Ltd
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 clinical trial will be conducted in Korea. Eligible patients diagnosed with MCI or mild Alzheimer's disease will be stratified by disease stage (MCI/mild AD) 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…
This description comes directly from the study's public registry record.
Yeonsil Moon, Professor · +82)70-4018-8009 · neuro_reply@neurobiogen.com
Dayoung Kim, Professor
Always discuss trial participation with your own doctor first.
| Chonnam National Unversity Hospital | Gwangju, Gwangju, South Korea | Recruiting |
| Hanyang University Guri Hospital | Guri-si, Gyeonggi-do, South Korea | Recruiting |
| The Catholic University of Korea St. Vincent's Hospital | Suwon, Gyeonggi-do, South Korea | Recruiting |
| Ajou University Hospital | Suwon, Gyeonggi-do, South Korea | Recruiting |
| Gachon University Gil Medical Center | Incheon, Incheon, South Korea | Recruiting |
| Hanyang University Seoul Hospital | Seoul, Seoul, South Korea | Recruiting |
| Konkuk University Medical Center | Seoul, Seoul, South Korea | Recruiting |
| Asan Medical Center | Seoul, Seoul, South Korea | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07027072