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NCT Number: NCT07496021

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

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Key information

Conditions

Early Alzheimers Disease Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

55 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yonsei University Yongin Severance Hospital, Gyeonggi-do, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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
  • Initiation or dosage/regimen changes of symptomatic treatments for dementia within 12 weeks prior to screening
  • Chronic use of medications acting on the CNS or those that may affect cognitive function within 8 weeks prior to screening
  • Regular use of medications that may alter the gut microbiota within 4 weeks prior to screening

Treatment and study plan

L. lactis CKDB001

Drug

Oral Capsule

Placebo

Drug

Oral Capsule

Primary outcomes

  1. Change from baseline in the ADAS-Cog 14 total score at Weeks 12 and 24

    Time frame: Baseline, Week 12, Week 24

    The score ranges from 0 to 90, with higher scores indicating greater cognitive impairment.

  2. Change from baseline in the ADAS-Cog 14 memory box score at Weeks 12 and 24

    Time frame: Baseline, Week 12, Week 24

    The score ranges from 0 to 90, with higher scores indicating greater cognitive impairment.

  3. Change from baseline in the ADCS-MCI-ADL score at Weeks 12 and 24

    Time frame: Baseline, Week 12, Week 24

    The score ranges from 0 to 53, with lower scores indicating greater functional impairment.

  4. Change from baseline in the K-MMSE score at Weeks 12 and 24

    Time frame: Baseline, Week 12, Week 24

    The score ranges from 0 to 30, with higher scores indicating better cognitive function.

  5. Change from baseline in the Global Clinical Dementia Rating (CDR) score at Week 24

    Time frame: Baseline, 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.

  6. Change from baseline in the Clinical Dementia Rating-Sum of Boxes (CDR-SB) score at Week 24

    Time frame: Baseline, 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.

  7. Change from baseline in amyloid PET imaging biomarkers at Week 24

    Time frame: Baseline, Week 24

  8. Change from baseline in blood-based Alzheimer's disease-related biomarkers at Week 24

    Time frame: Baseline, Week 24

  9. Change from baseline in blood cytokine levels at Week 24

    Time frame: Baseline, Week 24

Study contacts

Contact information is provided by the study sponsor or research team.

Bisong Kim

CONTACT

[email protected]

+82221940510

Sponsors and collaborators

Lead sponsor

CKD Bio Corporation

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 27, 2026
Registry last updated
Mar 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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