RecruitingPhase 2

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

Lead sponsor

NeuroBiogen Co., Ltd

Asset

KDS2010

Listed sites

Recruiting sites

Enrollment

114

estimated

Study population

Alzheimer’s disease, MCI / preclinical Alzheimer’s

Key I/E criteria

•Amyloid biomarker required (PET)•MMSE 21-30•Study partner/caregiver required

Primary endpoints

•Clinical Dementia Rating-Sum of Boxes (CDR-SB)•Mini-Mental State Examination (MMSE)•ADAS-Cog

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

RegistryKCT0010589CRIS

Org study IDNB_KDS_ADP2_23

NCT IDNCT07027072

Timeline

Milestones

Study first posted2025-06-18actual

Study start2025-08-06actual

Last update posted2026-06-22actual

Primary completion2027-06-30estimated

Study completion2027-12-31estimated

Assets

Drug assets

KDS2010

Study populations

Who this study enrolls

Alzheimer’s diseaseMCI / preclinical Alzheimer’s

Eligibility

Who can enroll

Minimum age50 Years

Maximum age85 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•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

Exclusion criteria

•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.)

-Gastrointestinal diseases, including gastric and duodenal ulcers, that may affect the safety evaluation according to the judgment of the investigator

-Psychiatric diagnosis or symptoms that may interfere with the study (uncontrolled major depression, uncontrolled schizophrenia, uncontrolled bipolar affective disorder, etc.), as assessed by the investigator

-Positive responses to items 4 or 5 on the Columbia University Suicide Severity Rating Scale (C-SSRS) during screening

-Other conditions deemed by the investigator to potentially affect the outcome of the study

•Subjects who have undergone or require treatment with the following:

-AD disease-modifying agents (aducanumab, lecanemab, donanemab, gantenerumab, solanezumab, blarcamesine, simufilam, tricaprilin, valiltramiprosate, etc.) within 12 weeks before screening

-Medications that may improve cognitive abilities or affect AD treatment (AChEIs, donepezil, galantamine, rivastigmine, tacrine, memantine, etc.) within 12 weeks before screening, except if the subject has been on a stable dose for at least 12 weeks before baseline and maintains the same composition/dosage/method of administration during the study period

-CNS-active drugs or those affecting cognitive function antidepressants other than serotonergic drugs [e.g., bupropion], sedatives [e.g., carbamazepine], dopamine antagonists [e.g., antipsychotics, metoclopramide], amfepramone, mazindol) within 12 weeks before screening

-Central anticholinergics and sedating H1-antihistamines within 12 weeks before screening.

However, exceptions are allowed for one-time use of the drugs, such as second-generation H1 antihistamines (e.g., cetirizine, levocetirizine, etc.) or peripheral anticholinergics with no central action (e.g., trospium for treating overactive bladder). But the use is prohibited for at least 3 days from the date of cognitive function evaluation.

•Other investigational products or clinical trial devices within four weeks before baseline or five times the half-life of the drug (whichever is longer, and patients can be enrolled after wash-out)

•Monoamine oxidase inhibitors (MAOIs) and linezolid within two weeks before baseline or five times the half-life of the drug (whichever is longer, and patients can be enrolled after wash-out)

•Opioids (pethidine, tramadol, tapentadol, etc.) within two weeks before baseline or five times the half-life of the drug (whichever is longer, and patients can be enrolled after wash-out)

•Cyclobenzaprine and St. John's wort within two weeks before baseline or five times the half-life of the drug (whichever is longer, and patients can be enrolled after wash-out)

•The following serotonergic drugs within two weeks before baseline or five times the half-life of the drug (whichever is longer, and patients can be enrolled after wash-out),

-selective serotonin (5HT1) agonists

-lithium

-lamotrigine

-ritonavir

-dapoxetine

-Selective serotonin reuptake inhibitors (SSRIs)

-dapoxetine

-Serotonin-norepinephrine reuptake inhibitors (SNRIs)

-Tricyclic or tetracyclic antidepressants

-triazolopyridine antidepressant However, amitriptyline ≤ 50 mg/day, trazodone ≤ 100 mg/day, citalopram ≤ 20 mg/day, and sertraline ≤ 100 mg/day are allowed without washout.

•Use of sympathomimetics (ephedrine, methylphenidate, amphetamine, methamphetamine, lisdexamfetamine, etc.) during the screening period

•Use of Dextromethorphan during the screening period

•Use of CYP3A4 strong inducer, CYP3A4 strong inhibitor, CYP2D6 strong inducer, and CYP2D6 strong inhibitor during the screening period

-Inability to undergo MRI or PET scans

-Pregnant or breastfeeding women

-Fertile women or men who are unwilling to use effective contraception* from the date of written consent until 12 weeks after the last administration of the investigational product

*Effective contraception is defined as follows, and at least one method should be used:

-Hormonal contraception (oral, injectable, implantable, etc.)

-Intrauterine device (IUD) or system (IUS)

-Sterilization or surgical procedures (vasectomy, bilateral tubal ligation/surgery, hysterectomy)

-Dual contraception methods: Simultaneous use of barrier methods (male condoms) with the methods listed above

-Absolute abstinence: Total abstinence from sexual intercourse is recognized if the investigator deems the subject's age, occupation, lifestyle, or sexual orientation assures contraception. However, periodic abstinence (calendar method, mucus method, and symptothermal method), withdrawal, and coitus interruptus are not recognized as effective contraception methods.

-Other conditions deemed by the investigator to be unsuitable for participation in the study

Endpoints (20)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Safety / tolerability / PK

Global cognition

Other (unclassified)

Amyloid biomarkers

Other clinical outcomes

Global cognition

5 endpoints

Primary/protocol endpoint

Change from Baseline in Clinical Dementia Rating - Sum of Boxes (CDR-SB) score

Time frame:Screening (-8 Week~), Week 4, Week 8, Week 12, Week 24, Week 26

Clinical Dementia Rating-Sum of Boxes (CDR-SB)

change from baseline, improvement

Primary/protocol endpoint

Time to ≥0.5-point increase in CDR-SB

Time frame:Up to Week 26

Clinical Dementia Rating-Sum of Boxes (CDR-SB)

time to event, event

Primary/protocol endpoint

Change from Baseline in Mini-Mental State Examination (MMSE) score

Time frame:Screening (-8 Week~), Week 12, Week 24, Week 26

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Primary/protocol endpoint

Change from Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog13) score

Time frame:Screening (-8 Week~), Week 12, Week 24, Week 26

ADAS-Cog

change from baseline, improvement

Primary/protocol endpoint

Change from Baseline in Amsterdam Instrumental Activities of Daily Living Questionnaire (A-IADL-Q-SV) score

Time frame:Screening (-8 Week~), Week 12, Week 24

change from baseline, improvement

Amyloid biomarkers

1 endpoint

Secondary/protocol endpoint

Percentage change from Baseline in plasma and Cerebrospinal Fluid(CSF) biomarkers

Time frame:Screening (-8 Week~), Week 12, Week 24

Phosphorylated tau 217 (p-tau217)

percent change from baseline, improvement

Safety / tolerability / PK

8 endpoints

Other/protocol endpoint

Number of subjects with treatment-related Adverse Events (AEs)

Time frame:Through study completion (approx. 26 weeks)

event count, event

Other/protocol endpoint

Pharmacokinetic Parameters: Area Under the Plasma Concentration-Time Curve over the dosing interval (τ) (AUCtau) at steady-state

Time frame:Baseline (Week 0), Week 12

concentration, descriptive

Other/protocol endpoint

Pharmacokinetic Parameters: Peak Plasma Concentration at Steady State (Cmax,ss)

Time frame:Baseline (Week 0), Week 12

concentration, descriptive

Other/protocol endpoint

Pharmacokinetic Parameters: Minimum Plasma Concentration at Steady State (Cmin,ss)

Time frame:Baseline (Week 0), Week 12

concentration, descriptive

Other/protocol endpoint

Pharmacokinetic Parameters: Average Plasma Concentration at Steady State (Cav,ss)

Time frame:Baseline (Week 0), Week 12

concentration, descriptive

Other/protocol endpoint

Pharmacokinetic Parameters: Time to Maximum Plasma Concentration at Steady State (Tmax,ss)

Time frame:Baseline (Week 0), Week 12

time to event, event

Other/protocol endpoint

Pharmacokinetic Parameters: Terminal Elimination Half-life (t1/2)

Time frame:Baseline (Week 0), Week 12

concentration, descriptive

Other/protocol endpoint

Pharmacokinetic Parameters: Peak-Trough Fluctuation at Steady State (PTF)

Time frame:Baseline (Week 0), Week 12

concentration, descriptive

Other clinical outcomes

1 endpoint

Other/protocol endpoint

Change from baseline in systolic and diastolic blood pressure

Time frame:Screening (-8 Week~), Baseline (Week 0), Week 4, Week 8, Week 12, Week 24, Week 26

change from baseline, improvement

Other (unclassified)

5 endpoints

Secondary/protocol endpoint/low confidence

Percentage change from Baseline in plasma Monoamine Oxidase B (MAO-B) specific activity

Time frame:Screening (-8 Week~), Week 26

percent change from baseline, improvement

Other/protocol endpoint/low confidence

Change from baseline in pulse rate

Time frame:Screening (-8 Week~), Baseline (Week 0), Week 4, Week 8, Week 12, Week 24, Week 26

change from baseline, improvement

Other/protocol endpoint/low confidence

Change from baseline in body temperature

Time frame:Screening (-8 Week~), Baseline (Week 0), Week 4, Week 8, Week 12, Week 24, Week 26

change from baseline, improvement

Other/protocol endpoint/low confidence

Change from baseline in laboratory test results

Time frame:Screening (-8 Week~), Baseline (Week 0), Week 4, Week 8, Week 12, Week 24, Week 26

change from baseline, improvement

Other/protocol endpoint/low confidence

Change from baseline in Columbia-Suicide Severity Rating Scale (C-SSRS) total score

Time frame:Screening (-8 Week~), Week 24

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.