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Does BCG Vaccination Reduce Biomarkers of Alzheimer's Disease?

NCT06078891 · Status: ENROLLING_BY_INVITATION · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-03-18

No results posted yet for this study

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.

Conditions

  • Alzheimer Disease, Late Onset

Interventions

BIOLOGICAL

BCG vaccine

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

Sponsors & Collaborators

  • Hebrew University of Jerusalem

    collaborator OTHER

  • Tamir Ben-Hur

    lead OTHER

Principal Investigators

  • Tamir Ben Hur, MD PhD · Hadassah Medical Organization

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
70 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-07-01
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06078891 on ClinicalTrials.gov