Early Alzheimers DiseaseNCT07496021
Safety and Efficacy of L. Lactis CKDB001 in Subjects With Early Alzheimer's Disease
A study testing L. lactis CKDB001 in people with Early Alzheimers Disease, run by CKD Bio Corporation at 2 sites in South Korea.
Trial 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 Read more about this study
- Who is it for?
- Ages 55 to 85 years
- Conditions the study is for
- Early Alzheimers Disease
- What is being tested?
- L. lactis CKDB001
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 23 Feb 2026to 31 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 18Show fewer
- History of seizure disorder or epilepsy
- History or suspicion of alcohol or substance abuse/dependence
- History of psychiatric disorders, including schizophrenia, bipolar disorder, or clinically significant major depressive disorder, with current active symptoms
- History of malignancy diagnosed or recurrent within 5 years prior to screening
- History of a major cardiovascular event within 12 months prior to screening
- Cardiovascular disease requiring the administration of anticoagulants
- 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
- Clinically significant gastrointestinal disorders within 3 months prior to screening, or conditions that may lead to malabsorption
- Treatment with any disease-modifying therapy for Alzheimer's disease within 1 year prior to screening
- Initiation or dosage/regimen changes of symptomatic treatments for dementia within 12 weeks prior to screening
- Chronic use of medications acting on the CNS or those that may affect cognitive function within 8 weeks prior to screening
- Regular use of medications that may alter the gut microbiota within 4 weeks prior to screening
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea2 sites, 2 recruiting
- Recruiting
Yonsei University Yongin Severance Hospital
Gyeonggi-do
- Recruiting
Yonsei University Severance Hospital
Seoul
About this study
Official title: 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
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
- Conditions
- Early Alzheimers Disease
- Being tested
- L. lactis CKDB001, Placebo
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L. lactis CKDB001Drug
Oral Capsule
PlaceboDrug
Oral Capsule
| Study group | Role | What they receive |
|---|---|---|
| L. lactis CKDB001 | Active comparator | Not described Receives: Drug: L. lactis CKDB001 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Week 12, Week 24
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.
Measured: Baseline, Week 12, Week 24
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.
Measured: Baseline, Week 12, Week 24
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.
Measured: Baseline, Week 12, Week 24
Change from baseline in the Global Clinical Dementia Rating (CDR) score at 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.
Measured: Baseline, Week 24
Change from baseline in the Clinical Dementia Rating-Sum of Boxes (CDR-SB) score at 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.
Measured: Baseline, Week 24
Change from baseline in amyloid PET imaging biomarkers at Week 24
Measured: Baseline, Week 24
Change from baseline in blood-based Alzheimer's disease-related biomarkers at Week 24
Measured: Baseline, Week 24
Change from baseline in blood cytokine levels at Week 24
Measured: Baseline, Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start23 Feb 2026
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early Alzheimers DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CKD Bio Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Woo Jung Kim, Principal investigator, Yonsei University Yongin Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07496021
- Sponsor's protocol ID
- CKDB001-03
- Status last verified
- Feb 2026
- First submitted
- 22 Mar 2026
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07496021
- Acronym / sponsor ID
- CKDB001-03
- Conditions
- Early Alzheimers Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- CKD Bio CorporationIndustry (pharma, biotech, devices)
- Study start
- 23 Feb 2026 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 27 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| L. lactis CKDB001 | Active comparator | Drug: L. lactis CKDB001 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (18 listed)
- Subjects with clinically significant diseases other than Alzheimer's disease that may confound cognitive assessment
- History of seizure disorder or epilepsy
- History or suspicion of alcohol or substance abuse/dependence
- History of psychiatric disorders, including schizophrenia, bipolar disorder, or clinically significant major depressive disorder, with current active symptoms
- History of malignancy diagnosed or recurrent within 5 years prior to screening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| L. lactis CKDB001Oral Capsule | Drug | L. lactis CKDB001 |
| PlaceboOral Capsule | Drug | Placebo |
Primary outcome
Change from baseline in the ADAS-Cog 14 total score at Weeks 12 and 24
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline, Week 24
Change from baseline in blood-based Alzheimer's disease-related biomarkers at Week 24
Time frame: Baseline, Week 24
Change from baseline in blood cytokine levels at Week 24
Time frame: Baseline, Week 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Woo Jung Kim principal investigator
Yonsei University Yongin Severance Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing L. lactis CKDB001 in people with Early Alzheimers Disease, run by CKD Bio Corporation at 2 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bisong Kim (+82221940510, bisong.kim@ckdbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in the ADAS-Cog 14 total score at Weeks 12 and 24 (time frame: Baseline, Week 12, Week 24). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2026.