L. lactis CKDB001 for people with early Alzheimer's disease

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

This 24-week study will test if oral L. lactis CKDB001 helps adults aged 55–85 with early Alzheimer's disease and positive amyloid PET compared with a placebo.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 55 Years to 85 Years
• Sex: All
• Sponsor: CKD Bio Corporation (Industry-sponsored)
• Locations: 2 sites (Gyeonggi-do and 1 other locations)
• Trial ID: NCT07496021 on ClinicalTrials.gov

What this trial studies

This is a randomized, double-blind, placebo-controlled, 24-week proof-of-concept trial comparing oral L. lactis CKDB001 to placebo in people with early Alzheimer's disease. Eligible participants are aged 55–85 with K-MMSE scores of 20–28, a global CDR of 0.5–1, and positive amyloid PET. Safety and cognitive outcomes will be tracked over the treatment period to look for changes in symptoms and tolerability. The sponsor is CKD Bio Corporation and study visits are conducted at Yonsei University Severance hospitals in Seoul and Yongin, South Korea.

Who should consider this trial

Good fit: Ideal candidates are adults 55–85 years old with early Alzheimer's disease who are amyloid PET–positive, have K-MMSE scores of 20–28, and a global CDR of 0.5–1.

Not a fit: Patients with more advanced dementia, non-amyloid causes of cognitive impairment, active CNS disease, seizure disorders, or significant medical conditions that affect cognition are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, CKDB001 could provide a new, noninvasive treatment that slows or improves cognitive symptoms in early Alzheimer's disease.

How similar studies have performed: Using probiotics or microbiome-targeted approaches for Alzheimer's is a novel strategy with some early preclinical and small clinical signals but no definitive successes to date.

Eligibility criteria

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

Where this trial is running

Gyeonggi-do and 1 other locations

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

Study contacts

• Principal investigator: Woo Jung Kim — Yonsei University Yongin Severance Hospital
• Study coordinator: Bisong Kim

Conditions Early Alzheimers Disease