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
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 55
Maximum Age: 85
Healthy Volunteers: f
View:
• 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)
Locations
Other Locations
Republic of Korea
Yonsei University Yongin Severance Hospital
RECRUITING
Gyeonggi-do
Yonsei University Severance Hospital
RECRUITING
Seoul
Contact Information
Primary
Bisong Kim
bisong.kim@ckdbio.com
+82221940510
Time Frame
Start Date: 2026-02-23
Estimated Completion Date: 2027-05-31
Participants
Target number of participants: 60
Treatments
Active_comparator: L. lactis CKDB001
Placebo_comparator: Placebo
Related Therapeutic Areas
Sponsors
Leads: CKD Bio Corporation