Does BCG Vaccination Reduce Biomarkers of Alzheimer's Disease?

NCT06078891 | Enrolling By Invitation Early Phase 1

• 1 other identifier: BCG-AD HMO-CTIL
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

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

  Four measurements of plasma p-tau181 levels (range 1-100 picogram/ml)

  1.5 years

Secondary Outcomes (2)

• Cognitive deterioration by Montreal Cognitive Assessment (MoCA) test

  1.5 years

• Plasma neurofilament-light levels by SIMOA technology

  1.5 years

Study Arms (1)

BCG vaccinated patients

EXPERIMENTAL

A single arm experiment to examine the effect of 3 standard intradermal vaccinations with BCG (at times 0, 1 month and 12 months) on plasma biomarkers.

Biological: BCG vaccine

Interventions

BCG vaccine BIOLOGICAL

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

BCG vaccinated patients

Eligibility Criteria

• Age: 70 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tamir Ben-Hur: lead
• Hebrew University of Jerusalem: collaborator

Study Sites (1)

Department of Neurology, Hadassah medical Center

Jerusalem, Israel

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

BCG Vaccine

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Tuberculosis Vaccines; Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Tamir Ben Hur, MD PhD

  Hadassah Medical Organization

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor and Chair, The Brain Divison

Model Details: A single group in treated patients to follow changes in plasma biomarkers levels.

Study Record Dates

• First Submitted: August 6, 2023
• First Posted: October 12, 2023
• Study Start: July 1, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: March 18, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)