Safety and Efficacy of L. Lactis CKDB001 in Subjects With Early Alzheimer's Disease

A Randomized, Placebo-Controlled, Double-Blind, 24-Week Proof-of-Concept Study to Evaluate the Safety and Efficacy of L. Lactis CKDB001 in Subjects With Early Alzheimer's Disease

Randomized, Placebo-Controlled, Double-Blind, 24-Week Proof-of-Concept Study to Evaluate the Safety and Efficacy of L. Lactis CKDB001 in Subjects With Early Alzheimer's Disease

Study Overview

• Status: Recruiting
• Conditions: Early Alzheimers Disease
• Intervention / Treatment: Drug: Placebo; Drug: L. lactis CKDB001

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bisong Kim; Phone Number: +82221940510; Email: bisong.kim@ckdbio.com

Study Locations

• South Korea
  • Gyeonggi-do, South Korea
    • Recruiting
    • Yonsei University Yongin Severance Hospital
  • Seoul, South Korea
    • Recruiting
    • Yonsei University Severance Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Male and female adults aged ≥55 and ≤85 years at the time of written consent
2. Subjects with a Korean Mini-Mental State Examination (K-MMSE) score of 20 to 28
3. Have a global Clinical Dementia Rating (CDR) score of 0.5 to 1 and a CDR Memory Box score of 0.5 or greater
4. Subjects who test positive for amyloid on Positron Emission Tomography (PET)

Exclusion Criteria:

1. Subjects with clinically significant diseases other than Alzheimer's disease that may confound cognitive assessment

   • History of central nervous system (CNS) diseases
   • Active central nervous system (CNS) infection capable of affecting cognitive function, or a history of infection resulting in neurological sequelae
   • Structural brain abnormalities identified on screening MRI that could account for cognitive impairment
   • Abnormal thyroid function identified at screening
   • Vitamin B12 deficiency identified at screening
2. History of seizure disorder or epilepsy
3. History or suspicion of alcohol or substance abuse/dependence
4. History of psychiatric disorders, including schizophrenia, bipolar disorder, or clinically significant major depressive disorder, with current active symptoms
5. History of malignancy diagnosed or recurrent within 5 years prior to screening
6. History of a major cardiovascular event within 12 months prior to screening
7. Cardiovascular disease requiring the administration of anticoagulants
8. Severe or active infectious disease requiring treatment with antibiotics or antivirals within 4 weeks prior to randomization, or expected to require such treatment during the study period
9. Clinically significant gastrointestinal disorders within 3 months prior to screening, or conditions that may lead to malabsorption
10. Treatment with any disease-modifying therapy for Alzheimer's disease within 1 year prior to screening
11. Initiation or dosage/regimen changes of symptomatic treatments for dementia within 12 weeks prior to screening
12. Chronic use of medications acting on the CNS or those that may affect cognitive function within 8 weeks prior to screening
13. Regular use of medications that may alter the gut microbiota within 4 weeks prior to screening

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Oral Capsule
Active Comparator: L. lactis CKDB001	Drug: L. lactis CKDB001; Oral Capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in amyloid PET imaging biomarkers at Week 24		Baseline, Week 24
Change from baseline in blood-based Alzheimer's disease-related biomarkers at Week 24		Baseline, Week 24
Change from baseline in blood cytokine levels at Week 24		Baseline, Week 24
Change from baseline in the ADAS-Cog 14 total score at Weeks 12 and 24	The score ranges from 0 to 90, with higher scores indicating greater cognitive impairment.	Baseline, Week 12, Week 24
Change from baseline in the ADAS-Cog 14 memory box score at Weeks 12 and 24	The score ranges from 0 to 90, with higher scores indicating greater cognitive impairment.	Baseline, Week 12, Week 24
Change from baseline in the ADCS-MCI-ADL score at Weeks 12 and 24	The score ranges from 0 to 53, with lower scores indicating greater functional impairment.	Baseline, Week 12, Week 24
Change from baseline in the K-MMSE score at Weeks 12 and 24	The score ranges from 0 to 30, with higher scores indicating better cognitive function.	Baseline, Week 12, Week 24
Change from baseline in the Global Clinical Dementia Rating (CDR) score at Week 24	The CDR scale assesses 6 domains of participant function on a 5-point scale(no impairment=0, questionable impairment=0.5, mild impairment=1, moderate impairment=2 and severe impairment=3). The score ranges from 0 to 3, with higher scores indicating greater severity of impairment.	Baseline, Week 24
Change from baseline in the Clinical Dementia Rating-Sum of Boxes (CDR-SB) score at Week 24	The CDR scale assesses 6 domains of participant function on a 5-point scale(no impairment=0, questionable impairment=0.5, mild impairment=1, moderate impairment=2 and severe impairment=3). The CDR-SB is the sum of the individual domain scores and ranges from 0 to 18, with higher scores indicating more severe impairment.	Baseline, Week 24

Collaborators and Investigators

• Sponsor: CKD Bio Corporation
• Investigators: Principal Investigator: Woo Jung Kim, Yonsei University Yongin Severance Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 23, 2026
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2027

Study Registration Dates

• First Submitted: March 22, 2026
• First Submitted That Met QC Criteria: March 22, 2026
• First Posted (Actual): March 27, 2026

Study Record Updates

• Last Update Posted (Actual): March 30, 2026
• Last Update Submitted That Met QC Criteria: March 25, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurocognitive Disorders; Dementia; Tauopathies; Neurodegenerative Diseases; Alzheimer Disease
• Other Study ID Numbers: CKDB001-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No