Early Alzheimers Disease
Conditions
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
Interventions
DRUGL. lactis CKDB001
Oral Capsule
DRUGPlacebo
Oral Capsule
Sponsors
CKD Bio Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
55 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in the ADAS-Cog 14 total score at Weeks 12 and 24 | Baseline, Week 12, Week 24 | The score ranges from 0 to 90, with higher scores indicating greater cognitive impairment. |
| Change from baseline in the ADAS-Cog 14 memory box score at Weeks 12 and 24 | Baseline, Week 12, Week 24 | The score ranges from 0 to 90, with higher scores indicating greater cognitive impairment. |
| Change from baseline in the ADCS-MCI-ADL score at Weeks 12 and 24 | Baseline, Week 12, Week 24 | The score ranges from 0 to 53, with lower scores indicating greater functional impairment. |
| Change from baseline in the K-MMSE score at Weeks 12 and 24 | Baseline, Week 12, Week 24 | The score ranges from 0 to 30, with higher scores indicating better cognitive function. |
| Change from baseline in the Global Clinical Dementia Rating (CDR) score at Week 24 | Baseline, Week 24 | The CDR scale assesses 6 domains of participant function on a 5-point scale(no impairment=0, questionable impairment=0.5, mild impairment=1, moderate impairment=2 and severe impairment=3). The score ranges from 0 to 3, with higher scores indicating greater severity of impairment. |
| Change from baseline in the Clinical Dementia Rating-Sum of Boxes (CDR-SB) score at Week 24 | Baseline, Week 24 | The CDR scale assesses 6 domains of participant function on a 5-point scale(no impairment=0, questionable impairment=0.5, mild impairment=1, moderate impairment=2 and severe impairment=3). The CDR-SB is the sum of the individual domain scores and ranges from 0 to 18, with higher scores indicating more severe impairment. |
| Change from baseline in amyloid PET imaging biomarkers at Week 24 | Baseline, Week 24 | — |
| Change from baseline in blood-based Alzheimer's disease-related biomarkers at Week 24 | Baseline, Week 24 | — |
| Change from baseline in blood cytokine levels at Week 24 | Baseline, Week 24 | — |
Countries
South Korea
Contacts
CONTACTBisong Kim
PRINCIPAL_INVESTIGATORWoo Jung Kim
Yonsei University Yongin Severance Hospital
Outcome results
None listed