L. lactis CKDB001 for people with early Alzheimer's disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, double-blind, placebo-controlled, 24-week proof-of-concept trial comparing oral L. lactis CKDB001 to placebo in people with early Alzheimer's disease. Eligible participants are aged 55–85 with K-MMSE scores of 20–28, a global CDR of 0.5–1, and positive amyloid PET. Safety and cognitive outcomes will be tracked over the treatment period to look for changes in symptoms and tolerability. The sponsor is CKD Bio Corporation and study visits are conducted at Yonsei University Severance hospitals in Seoul and Yongin, South Korea.

Why it matters

Who can join: the full rules

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

Where it's running

• Yonsei University Yongin Severance Hospital
  Gyeonggi-do, South Korea Recruiting
• Yonsei University Severance Hospital
  Seoul, South Korea Recruiting

Study contacts

• Principal investigator: Woo Jung Kim — Yonsei University Yongin Severance Hospital
• Study coordinator: Bisong Kim
• Email: bisong.kim@ckdbio.com
• Phone: +82221940510

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Urolithin A for early Alzheimer’s disease: a test with a nutritional supplement

  This trial tests whether taking urolithin A in addition to standard care helps people with early Alzheimer’s or mild cognitive impairment show better biomarkers and cognition.

  Recruiting University Hospital, Akershus · Prague · NCT07842146

• Stem Cells plus monoclonal antibodies for mild cognitive impairment or early Alzheimer's disease

  This study tests whether one infusion of human mesenchymal stem cells added to standard antibody therapy can slow cognitive and daily-living decline in people with mild Alzheimer's or mild cognitive impairment who are already on approved antibody treatment.

  Recruiting Phase 2 University of Miami · Miami, Florida · NCT07512362

• TTYP01 tablets for people with early symptomatic Alzheimer's disease

  This study will test whether two doses of TTYP01 tablets (60 mg and 90 mg) help people aged 60–85 with early symptomatic Alzheimer's disease (MCI due to AD or mild AD dementia) compared with placebo.

  Recruiting Phase 2 Shanghai Auzone Biological Technology Co., Ltd. · Chongqing, Chongqing Municipality · NCT07252440

• MK-2214 for people with early Alzheimer's disease

  This trial will test whether the drug MK-2214 can slow the spread of tau protein in the brains of people with mild cognitive impairment or mild dementia from Alzheimer's disease.

  Recruiting at 79 sites Phase 2 Merck Sharp & Dohme LLC · Irvine, California and 79 other locations · NCT07033494

• DNL628 safety, tolerability, and drug behavior in people with early Alzheimer's disease.

  This trial will test DNL628 versus placebo in people with early Alzheimer's disease to see if it is safe, well tolerated, and how the body handles the drug.

  Recruiting at 4 sites Phase 1 Denali Therapeutics Inc. · 's-Hertogenbosch and 3 other locations · NCT07328451

• Targeted magnetic stimulation of the precuneus to slow cognitive decline in Alzheimer's

  This will try repetitive magnetic brain stimulation of the precuneus to see if it slows memory and thinking decline in people aged 50–85 with biomarker-confirmed mild Alzheimer's.

  Recruiting Amsterdam UMC, location VUmc · Amsterdam · NCT07036328

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.