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

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Mild Cognitive Impairment (MCI), Mild Dementia, Alzheimer's Disease

In brief

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 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.

Key facts

Study ID: NCT07027072
Run by: NeuroBiogen Co., Ltd
People needed: 114
Starts: 2025-08-06
Expected to finish: 2027-12-31
Last updated by the study team: 2026-06-22

Who can join

Age: 50 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Male and female adults aged ≥50 and ≤85 years at the time of written consent
Patients with MCI or mild AD confirmed at screening according to the 2024 diagnostic criteria (APPENDIX 1) of the National Institute on Aging-Alzheimer's Association (NIA-AA)
Subjects whose total CDR score (CDR-GS) is 0.5 to 1.0 at screening (however, CDR memory score is ≥0.5)
Subjects with a Mini-Mental State Examination (MMSE) score of 21 to 30 at screening
Subjects who test positive for amyloid on Positron Emission Tomography (PET) during screening
Subjects who have a caregiver capable of providing accurate information about the subject's cognitive and functional abilities and appropriate for the planned assessments in the study, as judged by the investigator
Subjects (or their legal representatives) who have voluntarily agreed to participate in this study and have given written consent

You may not qualify if…

Cognitive impairment or dementia due to causes other than Alzheimer's disease
Vascular dementia, central nervous system infections (e.g., HIV, syphilis, etc.), head trauma, Creutzfeldt-Jakob disease, Pick's disease, Huntington's disease, Parkinson's disease, subdural hematoma, normal pressure hydrocephalus, brain tumor, thyroid disorders, parathyroid disorders, Vitamin B12 deficiency, folic acid deficiency, other metabolic and nutritional deficiencies, etc.
Alcohol or drug abuse, dependence
Subjects with cognitive impairment due to hypothyroidism, nutritional deficiencies, Vitamin B12 or folic acid deficiency as assessed during screening
Subjects confirmed during screening to have had the following medical history:
Malignant tumors within five years prior to screening except for basal cell carcinoma, cutaneous squamous cell carcinoma, thyroid cancer, or carcinoma in situ that has not recurred in over three years and is considered successfully treated by the investigator
History of alcohol or drug abuse within two years prior to screening
Loss of consciousness of unknown cause, or seizure within the past 52 weeks before screening
Unstable and clinically significant cardiovascular diseases despite appropriate treatment (acute coronary syndrome (ACS), tachycardia, clinically significant arrhythmias, cardiomyopathy, angina of at least CSS III, heart failure of NYHA II-IV, or clinically significant valvular heart disease) within 24 weeks before baseline
Severe or active infectious diseases requiring antibiotics or antivirals within four weeks before baseline
A history of stroke involving a major vascular area, transient ischemic attack (TIA), epilepsy, or severe head trauma with loss of consciousness
Hypersensitivity or allergy to any components of the investigational product
Subjects confirmed during screening to have had the following accompanying disease:
Clinically significant neurological diseases or serious pathological findings affecting cognitive function as confirmed by brain imaging studies within 52 weeks prior to screening, including multiple sclerosis, normal pressure hydrocephalus, brain tumor (however, exceptions are allowed for lesions diagnosed as benign and with a maximum diameter of less than 1 cm), spinal cord infarction, major hemorrhage (defined as having a diameter > 1 cm in MRI) or subdural hemorrhage, cerebral vascular malformation, communicating hydrocephalus, inflammatory demyelinating diseases, etc.
Uncontrolled hypertension despite appropriate treatment at screening or baseline (SBP ≥160 mmHg or DBP ≥100 mmHg)
Dizziness or fainting when standing due to orthostatic hypotension that may affect the evaluation according to the judgment of the investigator
Uncontrolled diabetes (HbA1c > 9%) during screening, despite appropriate treatment
Bleeding disorders (Platelet <50,000/mm³) during screening, despite appropriate treatment
Patients with severe hepatic impairment (Child-pugh class C) at screening
Following laboratory test values at screening:
AST or ALT > 2.5 x ULN
total bilirubin > 1.5 x ULN (however, in case of Gilbert syndrome, > 3.0 mg/dL)
MDRD eGFR < 30 mL/min/1.73 m²
QTcF interval >450 msecs for male or 470 msecs for female(12-lead ECG) during screening
Gastrointestinal diseases that may affect oral administration or absorption (celiac disease, Crohn's disease, intestinal resection, etc.)

Where it is running

Chonnam National Unversity Hospital — Gwangju, Gwangju, South Korea (enrolling)
Hanyang University Guri Hospital — Guri-si, Gyeonggi-do, South Korea (enrolling)
The Catholic University of Korea St. Vincent's Hospital — Suwon, Gyeonggi-do, South Korea (enrolling)
Ajou University Hospital — Suwon, Gyeonggi-do, South Korea (enrolling)
Gachon University Gil Medical Center — Incheon, Incheon, South Korea (enrolling)
Hanyang University Seoul Hospital — Seoul, Seoul, South Korea (enrolling)
Konkuk University Medical Center — Seoul, Seoul, South Korea (enrolling)
Asan Medical Center — Seoul, Seoul, South Korea (enrolling)

Full record on ClinicalTrials.gov

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