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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
L. lactis CKDB001
DrugOral Capsule
Placebo
DrugOral Capsule
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: L. lactis CKDB001Active comparator 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change from baseline in the ADAS-Cog 14 total score at Weeks 12 and 24
The score ranges from 0 to 90, with higher scores indicating greater cognitive impairment.
Time frame
Baseline, Week 12, Week 242
Change from baseline in the ADAS-Cog 14 memory box score at Weeks 12 and 24
The score ranges from 0 to 90, with higher scores indicating greater cognitive impairment.
Time frame
Baseline, Week 12, Week 243
Change from baseline in the ADCS-MCI-ADL score at Weeks 12 and 24
The score ranges from 0 to 53, with lower scores indicating greater functional impairment.
Time frame
Baseline, Week 12, Week 244
Change from baseline in the K-MMSE score at Weeks 12 and 24
The score ranges from 0 to 30, with higher scores indicating better cognitive function.
Time frame
Baseline, Week 12, Week 24Sponsors and contacts
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Source ClinicalTrials.gov