Alzheimer Disease, Late Onset Clinical Trial
Official title:
BCG and Plasma Amyloid in Non-Demented Adults
Verified date | December 2021 |
Source | Mindful Diagnostics and Therapeutics, LLC |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 49 |
Est. completion date | December 5, 2021 |
Est. primary completion date | December 4, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 50 Years to 80 Years |
Eligibility | Inclusion Criteria: - BCG naive - Ability to read, understand and sign consent form Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
United States | Mindful Diagnostics and Therapeutics | Eau Claire | Wisconsin |
Lead Sponsor | Collaborator |
---|---|
Mindful Diagnostics and Therapeutics, LLC |
United States,
Dow CT. Proposing BCG Vaccination for Mycobacterium avium ss. paratuberculosis (MAP) Associated Autoimmune Diseases. Microorganisms. 2020 Feb 5;8(2). pii: E212. doi: 10.3390/microorganisms8020212. Review. — View Citation
Gofrit ON, Bercovier H, Klein BY, Cohen IR, Ben-Hur T, Greenblatt CL. Can immunization with Bacillus Calmette-Guérin (BCG) protect against Alzheimer's disease? Med Hypotheses. 2019 Feb;123:95-97. doi: 10.1016/j.mehy.2019.01.007. Epub 2019 Jan 11. — View Citation
Gofrit ON, Klein BY, Cohen IR, Ben-Hur T, Greenblatt CL, Bercovier H. Bacillus Calmette-Guérin (BCG) therapy lowers the incidence of Alzheimer's disease in bladder cancer patients. PLoS One. 2019 Nov 7;14(11):e0224433. doi: 10.1371/journal.pone.0224433. eCollection 2019. — View Citation
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Schindler SE, Bollinger JG, Ovod V, Mawuenyega KG, Li Y, Gordon BA, Holtzman DM, Morris JC, Benzinger TLS, Xiong C, Fagan AM, Bateman RJ. High-precision plasma ß-amyloid 42/40 predicts current and future brain amyloidosis. Neurology. 2019 Oct 22;93(17):e1647-e1659. doi: 10.1212/WNL.0000000000008081. Epub 2019 Aug 1. — View Citation
Westman G, Berglund D, Widén J, Ingelsson M, Korsgren O, Lannfelt L, Sehlin D, Lidehall AK, Eriksson BM. Increased inflammatory response in cytomegalovirus seropositive patients with Alzheimer's disease. PLoS One. 2014 May 7;9(5):e96779. doi: 10.1371/journal.pone.0096779. eCollection 2014. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Plasma Amyloid | Level of Plasma Peptides 42/40 pre-BCG vaccination are compared with levels nine months post vaccination | 9 months | |
Secondary | Change in Immune Risk Profile | T-cell phenotype: CD4:CD8 ratios are measured pre-BCG vaccination and nine months post vaccination. | nine months |
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