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BCG and Plasma Amyloid in Non-Demented Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04449926
Recruitment Status : Not yet recruiting
First Posted : June 29, 2020
Last Update Posted : June 29, 2020
Sponsor:
Information provided by (Responsible Party):
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 off 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.

Condition or disease Intervention/treatment Phase
Alzheimer Disease, Late Onset Biological: Bacillus of Calmette and Guerin (BCG) Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: BCG and Plasma Amyloid in Non-Demented Adults
Estimated Study Start Date : October 2020
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : December 31, 2021


Arm Intervention/treatment
Experimental: BCG Vaccinated
Experimental: BCG Group FDA-approved BCG Tice strain, procured from Merck, will be used. The vaccine will be reconstituted according to the package insert. In brief, a vial containing ~1x10^8 CFU of lyophilized BCG will be reconstituted in 50 mL of saline. A single dose will consist of 0.1 mL (~2x10^5 CFU) will be administered by slow intradermal injection using a 25 gauge/ 0.5 mm syringe in the deltoid area. A follow up "booster" dose will be given one month after the initial dose.
Biological: Bacillus of Calmette and Guerin (BCG)
Prime and boost vaccination




Primary Outcome Measures :
  1. Change in Plasma Amyloid [ Time Frame: 9 months ]
    Level of Plasma Peptides 42/40 pre-BCG vaccination are compared with levels nine months post vaccination


Secondary Outcome Measures :
  1. Change in Immune Risk Profile [ Time Frame: nine months ]
    T-cell phenotype: CD4:CD8 ratios are measured pre-BCG vaccination and nine months post vaccination.



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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04449926


Contacts
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Contact: Coad T Dow, M.D. 715-577-5656 ctomdow@gmail.com

Locations
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United States, Wisconsin
Mindful Diagnostics and Therapeutics
Eau Claire, Wisconsin, United States, 54701-3016
Contact: Alie Larson    715-456-7336    info@mindfuldt.com   
Principal Investigator: Coad T Dow, M.D.         
Sponsors and Collaborators
Mindful Diagnostics and Therapeutics, LLC
Investigators
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Principal Investigator: Coad T Dow, M.D. Mindful Diagnostics and Therapeutics
Publications:

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Responsible Party: Mindful Diagnostics and Therapeutics, LLC
ClinicalTrials.gov Identifier: NCT04449926    
Other Study ID Numbers: BCG-PANDA 01
First Posted: June 29, 2020    Key Record Dates
Last Update Posted: June 29, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Mindful Diagnostics and Therapeutics, LLC:
Alzheimer's disease
biomarker
BCG
plasma amyloid
peptides 42/40
heterologous effect
immune risk profile
CMV
HHV5
immunossenescence
Additional relevant MeSH terms:
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Alzheimer Disease
Late Onset Disorders
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Disease Attributes
Pathologic Processes