NCT06078891Enrolling by invitationEarly phase 1
Does BCG Vaccination Reduce Biomarkers of Alzheimer's Disease?
Source: ClinicalTrials.gov · Last updated 18 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 6 Aug 2023
- Start date
- 1 Jul 2023
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- Tamir Ben-Hur
- Diseases
- Alzheimer disease
- NCT number
- NCT06078891
What you commit to
- Study type: Interventional · Early phase 1
- Planned participants: 60
- From 1 Jul 2023 to the primary completion date, 31 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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.
Other
- Above 10mm induration diameter at 48 hours after initial PPD test.
Who the study is looking for
- 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.
Age in the registry: 70 years to 80 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Neurology, Hadassah medical Center Coordinator of this site? Confirm its status | Jerusalem | Israel | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.