Status:
ENROLLING_BY_INVITATION
Does BCG Vaccination Reduce Biomarkers of Alzheimer's Disease?
Lead Sponsor:
Tamir Ben-Hur
Collaborating Sponsors:
Hebrew University of Jerusalem
Conditions:
Alzheimer Disease, Late Onset
Eligibility:
All Genders
70-80 years
Phase:
EARLY_PHASE1
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 func...
Detailed Description
Brain accumulation of insoluble Beta-Amyloid and of hyperphosphorylated tau protein -rich neurofibrillary tangles in Alzheimer's disease (AD), accompanied by oxidative stress and sustained inflammatio...
Eligibility Criteria
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
- 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.
Key Trial Info
Start Date :
July 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06078891
Start Date
July 1 2023
End Date
December 31 2025
Last Update
March 18 2025
Active Locations (1)
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1
Department of Neurology, Hadassah medical Center
Jerusalem, Israel