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

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Early Alzheimers Disease

In brief

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

Key facts

Study ID

NCT07496021

Run by

CKD Bio Corporation

People needed

60

Starts

2026-02-23

Expected to finish

2027-05-31

Last updated by the study team

2026-03-30

Who can join

Age: 55 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

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
• 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

Where it is running

• Yonsei University Yongin Severance Hospital — Gyeonggi-do, South Korea (enrolling)
• Yonsei University Severance Hospital — Seoul, South Korea (enrolling)

Full record on ClinicalTrials.gov

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