By InvitationEarly Phase 1

Does BCG Vaccination Reduce Biomarkers of Alzheimer's Disease?

Israel60 participantsStarted 2023-07-01

Plain-language summary

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.

Who can participate

Age range70 Years – 80 Years

SexALL

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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.

What they're measuring

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

Timeframe: 1.5 years

Trial details

NCT IDNCT06078891

SponsorTamir Ben-Hur

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12-31