Clinical trial

Does BCG Vaccination Reduce Biomarkers of Alzheimer's Disease?

Name

BCG-AD HMO-CTIL

Description

The goal of this clinical trial is to test whether vaccination with the BCG vaccine may improve the blood level of a biomarker of Alzheimer's disease (AD) in participants who are cognitively- and functionally- intact elderly (70-80 years old) participants, who display pathologically high levels of the blood biomarker. The main questions it aims to answer are: * Does BCG vaccination lower the plasma level of phosphorylated Tau protein (p-tau181). * Do vaccinated participants remains stable cognitively. Participants will be asked to: * Undergo cognitive and behavioral evaluation. * Receive 3 BCG vaccinations over the course of 1 year. * Perform blood tests on several occasions. All participants will be treated and followed.

Trial arms

Trial start

2023-07-01

Estimated PCD

2024-07-01

Trial end

2025-12-31

Phase

Early phase I

Treatment

BCG vaccine

Three intra-dermal vaccinations over a period of one year.

Arms:

BCG vaccinated patients

Size

Primary endpoint

Plasma phosphorylated Tau (p-tau181) biomarker level, measured in picogram/ml by SIMOA technology.

1.5 years

Eligibility criteria

Inclusion Criteria: * 70-80 years old patients with self-reported preserved cognitive function and instrumental activities of daily life (iADL). * MoCA score of ≥26. * Increased plasma p-tau181 level. Exclusion Criteria: * Extrapyramidal signs, documented CVA, existence of multi-infarct dementia or fronto-temporal dementia according to clinical impression by treating cognitive neurologist. * Active cancer, severe cardio-pulmonary disease or other medical condition which negatively affects ability to evaluate patients and complete follow-up. * Active glucocorticoids treatment, chronic immunosuppressive medications, or currently living with an immunosuppressed individual to prevent an adverse event from the administration of this live vaccine. * Above 10mm induration diameter at 48 hours after initial PPD test. * Inability to sign an informed consent due to psychiatric or dementing condition.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'A single group in treated patients to follow changes in plasma biomarkers levels.', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 60, 'type': 'ESTIMATED'}}

Updated at

2023-10-12

1 organization

1 product

2 indications

Organization

Product

Indication

Indication