Actively Recruiting
Safety and Efficacy of L. Lactis CKDB001 in Subjects With Early Alzheimer's Disease
Led by CKD Bio Corporation · Updated on 2026-03-30
60
Participants Needed
2
Research Sites
66 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Safety and Efficacy of L. Lactis CKDB001 in Subjects With Early Alzheimer's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 55 to 85 years at the time of consent
- Korean Mini-Mental State Examination (K-MMSE) score between 20 and 28
- Global Clinical Dementia Rating (CDR) score between 0.5 and 1 with a CDR Memory Box score of 0.5 or higher
- Positive amyloid PET scan indicating amyloid presence
You will not qualify if you...
- Clinically significant diseases other than Alzheimer's that could affect cognitive assessment, including CNS diseases, infections affecting the CNS, structural brain abnormalities on MRI, abnormal thyroid function, or vitamin B12 deficiency
- History of seizure disorder or epilepsy
- History or suspicion of alcohol or substance abuse or dependence
- History of psychiatric disorders such as schizophrenia, bipolar disorder, or major depressive disorder with active symptoms
- History of cancer diagnosed or recurring within 5 years prior to screening
- Major cardiovascular event within 12 months before screening
- Cardiovascular disease requiring anticoagulants
- Severe or active infections needing antibiotics or antivirals within 4 weeks before randomization or expected during the study
- Significant gastrointestinal disorders within 3 months prior to screening or malabsorption conditions
- Treatment with disease-modifying Alzheimer's therapies within 1 year prior to screening
- Changes in dementia symptomatic treatments within 12 weeks prior to screening
- Chronic use of CNS-acting or cognition-affecting medications within 8 weeks prior to screening
- Regular use of medications altering gut microbiota within 4 weeks prior to screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Yonsei University Yongin Severance Hospital
Gyeonggi-do, South Korea
Actively Recruiting
2
Yonsei University Severance Hospital
Seoul, South Korea
Actively Recruiting
Research Team
B
Bisong Kim
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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