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Recruiting NCT07496021

Safety and Efficacy of L. Lactis CKDB001 in Subjects With Early Alzheimer's Disease

No phase Interventional Early Alzheimers Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: L. lactis CKDB001, Placebo.
Who it may be relevant to
Registry conditions: Early Alzheimers Disease. Basic parameters: 55 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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

  • Drug L. lactis CKDB001
    Oral Capsule
  • Drug Placebo
    Oral Capsule

Primary outcome measures

  • Change from baseline in the ADAS-Cog 14 total score at Weeks 12 and 24 [Time frame: Baseline, Week 12, Week 24]
  • Change from baseline in the ADAS-Cog 14 memory box score at Weeks 12 and 24 [Time frame: Baseline, Week 12, Week 24]
  • Change from baseline in the ADCS-MCI-ADL score at Weeks 12 and 24 [Time frame: Baseline, Week 12, Week 24]
  • Change from baseline in the K-MMSE score at Weeks 12 and 24 [Time frame: Baseline, Week 12, Week 24]
  • Change from baseline in the Global Clinical Dementia Rating (CDR) score at Week 24 [Time frame: Baseline, Week 24]
  • Change from baseline in the Clinical Dementia Rating-Sum of Boxes (CDR-SB) score at Week 24 [Time frame: Baseline, Week 24]
  • 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]

Eligibility criteria

Inclusion criteria

  • 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)

Exclusion criteria

  • 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
  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

South Korea · 2 centers
  • Yonsei University Yongin Severance Hospital — Gyeonggi-do
  • Yonsei University Severance Hospital — Seoul

Identifiers

NCT: NCT07496021 · CKDB001-03

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗