Status:
COMPLETED
BCG and Plasma Amyloid in Non-Demented Adults
Lead Sponsor:
Mindful Diagnostics and Therapeutics, LLC
Conditions:
Alzheimer Disease, Late Onset
Eligibility:
All Genders
50-80 years
Phase:
PHASE2
Brief Summary
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 u...
Detailed Description
Alzheimer's disease (AD) is commonly regarded as Alzheimer's dementia. It is now understood that changes in the brain that result in late-onset AD dementia start years or even decades prior to clinica...
Eligibility Criteria
Inclusion
- BCG naive
- Ability to read, understand and sign consent form
Exclusion
- 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.
Key Trial Info
Start Date :
November 9 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 5 2021
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT04449926
Start Date
November 9 2020
End Date
December 5 2021
Last Update
December 23 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Mindful Diagnostics and Therapeutics
Eau Claire, Wisconsin, United States, 54701-3016