Clinical Trials in South Korea / NCT07496021
Recruiting
Not applicable
Safety and Efficacy of L. Lactis CKDB001 in Subjects With Early Alzheimer's Disease
NCT07496021 · tracked via the Priya Life Science South Korea tracker
Condition(s) studied
Early Alzheimers Disease
Investigational drug(s) / intervention(s)
L. lactis CKDB001Placebo
L. lactis CKDB001: Oral Capsule
Placebo: Oral Capsule
Study 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
Eligibility
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
Primary outcome measure(s)
- Change from baseline in the ADAS-Cog 14 total score at Weeks 12 and 24 — Baseline, Week 12, Week 24
The score ranges from 0 to 90, with higher scores indicating greater cognitive impairment. - Change from baseline in the ADAS-Cog 14 memory box score at Weeks 12 and 24 — Baseline, Week 12, Week 24
The score ranges from 0 to 90, with higher scores indicating greater cognitive impairment. - Change from baseline in the ADCS-MCI-ADL score at Weeks 12 and 24 — Baseline, Week 12, Week 24
The score ranges from 0 to 53, with lower scores indicating greater functional impairment. - Change from baseline in the K-MMSE score at Weeks 12 and 24 — Baseline, Week 12, Week 24
The score ranges from 0 to 30, with higher scores indicating better cognitive function. - Change from baseline in the Global Clinical Dementia Rating (CDR) score at Week 24 — 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. - Change from baseline in the Clinical Dementia Rating-Sum of Boxes (CDR-SB) score at Week 24 — 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. - 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
Trial sites (2)
| Facility | City | Region | Status |
|---|---|---|---|
| Yonsei University Yongin Severance Hospital | Gyeonggi-do | South Korea | Recruiting |
| Yonsei University Severance Hospital | Seoul | South Korea | Recruiting |
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07496021 on ClinicalTrials.gov ↗ ← All trials in South Korea