Could a probiotic slow Alzheimer's? new study seeks answers
NCT ID NCT07496021
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study is testing whether a probiotic called L. lactis CKDB001 can safely slow memory and thinking decline in people with early Alzheimer's disease. About 60 adults aged 55–85 with mild symptoms and positive amyloid brain scans will receive either the probiotic or a placebo for 24 weeks. Researchers will measure changes in cognition, daily function, and brain biomarkers to see if the treatment has any benefit.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2026
- Expected to finish
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May 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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55 to 85 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Yonsei University Severance Hospital
RECRUITINGSeoul, South Korea
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Yonsei University Yongin Severance Hospital
RECRUITINGGyeonggi-do, South Korea
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