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

NCT07496021 | Recruiting

• 1 other identifier: CKDB001-03
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Early Alzheimers Disease

Outcome Measures

Primary Outcomes (9)

• 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

• 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

Study Arms (2)

L. lactis CKDB001

ACTIVE COMPARATOR

Drug: L. lactis CKDB001

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

L. lactis CKDB001 DRUG

Oral Capsule

L. lactis CKDB001

Placebo DRUG

Oral Capsule

Placebo

Eligibility Criteria

• Age: 55 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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
• History of seizure disorder or epilepsy
• History or suspicion of alcohol or substance abuse/dependence
• History of psychiatric disorders, including schizophrenia, bipolar disorder, or clinically significant major depressive disorder, with current active symptoms
• History of malignancy diagnosed or recurrent within 5 years prior to screening
• History of a major cardiovascular event within 12 months prior to screening
• Cardiovascular disease requiring the administration of anticoagulants
• 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
• Clinically significant gastrointestinal disorders within 3 months prior to screening, or conditions that may lead to malabsorption
• Treatment with any disease-modifying therapy for Alzheimer's disease within 1 year prior to screening

Sponsors & Collaborators

• CKD Bio Corporation: lead

Study Sites (2)

Yonsei University Yongin Severance Hospital

Gyeonggi-do, South Korea

RECRUITING

Yonsei University Severance Hospital

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Woo Jung Kim

  Yonsei University Yongin Severance Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bisong Kim

CONTACT

+82221940510; bisong.kim@ckdbio.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2026
• First Posted: March 27, 2026
• Study Start: February 23, 2026
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2027
• Last Updated: March 30, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (2)