Safety and Efficacy of L. Lactis CKDB001 in Subjects With Early Alzheimer's Disease
ConditionEarly Alzheimers Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age55-85
SponsorCKD Bio Corporation
About this trial
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 criteria
Qualifiers
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)
Disqualifiers
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
Trial design
Treatments tested in this trial
- L. lactis CKDB001
- Placebo
Treatment groups
60 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov