BCG and Plasma Amyloid in Non-Demented Adults

INTRODUCTION

  • Org Study ID: BCG-PANDA 01
  • Secondary ID: N/A
  • NTC ID: NCT04449926
  • Sponsor: Mindful Diagnostics and Therapeutics, LLC

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 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.

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 clinical dementia. Biomarkers aid in diagnosing AD however, currently approved
biomarkers have drawbacks as they are invasive and expensive. The two most commonly used
biomarkers are amyloid PET scan and spinal tap for amyloid and tau. A new plasma amyloid test
has received "Breakthrough Device Designation" from the US-FDA. As an investigational tool,
this blood test for amyloid peptides 42/40 levels accurately predicts brain amyloidosis in
cognitively normal individuals. In the past 100 years, four billion doses of BCG vaccination
have been given for tuberculosis prevention. A favorable effect with BCG for non-tuberculous
mycobacteria is also recognized in cervical lymphadeniits, leprosy and Buruli's ulcer.
Recently, BCG has found favorable use in autoimmune diseases type 1 diabetes (T1D) and
multiple sclerosis (MS); moreover, a protective role by BCG for Alzheimer's disease has been
described. Adult exposure to BCG lessened the risk of AD by four-fold. This is an
interventional pilot study to test 50 non-demented adults measuring their plasma amyloid
42/40 level prior to BCG prime/boost followed with the same plasma amyloid testing 9 months
after vaccination. Sub-clinical CMV infection is felt to drive immune senescence and increase
the risk of AD; we will test for CMV antibodies and we will measure lymphocyte phenotype
prior to BCG and at study end to look for an immune-modulating effect on this indicator of
immunosenescence.


  • Overall Status
    Recruiting
  • Start Date
    January 9, 2021
  • Phase
    Phase 2
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Change in Plasma Amyloid

Primary Outcome 1 - Timeframe: 9 months

CONDITION

  • Alzheimer Disease
  • Late Onset

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.

Gender: All

Minimum Age: 80 Years

Maximum Age: 50 Years

Healthy Volunteers: Accepts Healthy Volunteers

OFFICIAL INFORMATION

Name: Coad T Dow, M.D.

Role: Principal Investigator

Affiliation: Mindful Diagnostics and Therapeutics

Overall Contact

Name: Coad T Dow, M.D.

Phone: 715-577-5656

Email: ctomdow@gmail.com

LOCATION

Facility Status Contact
Facility: Mindful Diagnostics and Therapeutics
Eau Claire, Wisconsin 54701-3016
United States
Status: Recruiting Contact:
Alie Larson
715-456-7336
info@mindfuldt.com