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Enrolling by invitationEarly phase 1

Tests BCG vaccine to lower an Alzheimer's blood marker in older adults

Tests BCG vaccine in cognitively healthy adults aged 70 to 80 with high p-tau181.

Plain-language title generated from the registry record
Registry title: Does BCG Vaccination Reduce Biomarkers of Alzheimer's Disease?

Key facts

Where
Jerusalem, IsraelSee the site
Phase
Early phase 1

Could this be for you?

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 70 and 80 years old?

Source: NCT06078891, who can take part

Where in Israel

  • Department of Neurology, Hadassah medical CenterJerusalem, IsraelNo longer taking part

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
Print a page for my doctor

Trial details

Who runs it
Tamir Ben-Hur
Trial code
NCT06078891
Record updated
18 March 2025
Original 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.Read full original descriptionShow less

Does BCG Vaccination Reduce Biomarkers of Alzheimer's Disease?

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.

Inclusion: 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: 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; 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; Inability to sign an informed consent due to psychiatric or dementing condition; Above 10mm induration diameter at 48 hours after initial PPD test.

ClinicalTrials.gov NCT06078891