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BCG-AD

Enrolling by invitationPhase EARLY_1

Does BCG Vaccination Reduce Biomarkers of Alzheimer's Disease?

Lead sponsor

Tamir Ben-Hur

Asset

BCG vaccine

Listed sites

Recruiting sites

Enrollment

estimated

Study population

Alzheimer’s disease

Key I/E criterion

•MoCA ≥26

Primary endpoint

•Phosphorylated tau 181 (p-tau181)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDBCG-AD HMO-CTIL

NCT IDNCT06078891

Timeline

Milestones

Study start2023-07-01actual

Study first posted2023-10-12actual

Last update posted2025-03-18actual

Primary completion2025-12-31estimated

Study completion2025-12-31estimated

Assets

Drug assets

BCG vaccine

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age70 Years

Maximum age80 Years

SexAll

Healthy volunteersAccepted

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.

Endpoints (3)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Global cognition

Tau biomarkers

Neurodegeneration biomarkers

Global cognition

1 endpoint

Secondary/protocol endpoint

Cognitive deterioration by Montreal Cognitive Assessment (MoCA) test

Time frame:1.5 years

Montreal Cognitive Assessment (MoCA)

ratio, descriptive

Tau biomarkers

1 endpoint

Primary/protocol endpoint

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

Time frame:1.5 years

Phosphorylated tau 181 (p-tau181)

descriptive

Neurodegeneration biomarkers

1 endpoint

Secondary/protocol endpoint

Plasma neurofilament-light levels by SIMOA technology

Time frame:1.5 years

Neurofilament light (NfL)

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.