Does BCG Vaccination Reduce Biomarkers of Alzheimer's Disease? (NCT06078891) | Clinical Trial Compass
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 range
70 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Plasma phosphorylated Tau (p-tau181) biomarker level, measured in picogram/ml by SIMOA technology.