Safety and Efficacy of L. Lactis CKDB001 in Subjects With Early Alzheimer's Disease
Trial Parameters
Brief 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 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