BCG and Plasma Amyloid in Non-Demented Adults

Completed · Phase 2

Conditions studied: Alzheimer Disease, Late Onset

In brief

BCG vaccination, the most widely used vaccination in the world, is used to reduce risk of tuberculosis infection; it is used for other mycobacterial infections as well, benefiting leprosy and Buruli ulcer. BCG has "heterologous" effects that aids in an array of non-mycobacterial and viral infections as well as bladder cancer. It is the heterologous effect, sometimes called the "off-target" effect that may offer benefit in Alzheimer's disease. Population studies and studies of adults receiving BCG show a lessened risk of Alzheimer's disease. The study will see if BCG vaccination will alter a plasma test for amyloid, a biomarker for cerebral amyloid.

Key facts

Study ID

NCT04449926

Run by

Mindful Diagnostics and Therapeutics, LLC

People needed

49

Starts

2020-11-09

Expected to finish

2021-12-05

Last updated by the study team

2021-12-23

Who can join

Age: 50 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• BCG naive
• Ability to read, understand and sign consent form

You may not qualify if…

• Known allergy to (components of) the BCG vaccine or serious adverse events to prior vaccine administration
• Known active or latent Mycobacterium tuberculosis or with another mycobacterial species. A history of - or a suspicion of M. tuberculosis infection.
• Fever (>38 C) within the past 24 hours.
• Suspicion of active viral or bacterial infection.
• Vaccination in the past 4 weeks or expected vaccination during the study period, independent of the type of vaccination.
• Severely immunocompromised subjects. This exclusion category comprises: a) subjects with known infection by the human immunodeficiency virus (HIV-1); b) neutropenic subjects with less than 500 neutrophils/mm3; c) subjects with solid organ transplantation; d) subjects with bone marrow transplantation; e) subjects under chemotherapy; f) subjects with primary immunodeficiency; g) severe lymphopenia with less than 400 lymphocytes/mm3; h) treatment with any anti-cytokine therapies. i) treatment with oral or intravenous steroids defined as daily doses of 10mg prednisone or equivalent for longer than 3 months, or probable use of oral or intravenous steroids in the following four weeks.
• Active solid or non-solid malignancy or lymphoma within the prior two years.

Where it is running

• Mindful Diagnostics and Therapeutics — Eau Claire, Wisconsin, United States

Full record on ClinicalTrials.gov

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