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Trial record 1 of 1 for:    NCT05183516
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Tdap and Biomarkers of Alzheimer's Disease

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ClinicalTrials.gov Identifier: NCT05183516
Recruitment Status : Not yet recruiting
First Posted : January 10, 2022
Last Update Posted : August 25, 2022
Sponsor:
Collaborator:
Infectious Disease Society of America
Information provided by (Responsible Party):
Mindful Diagnostics and Therapeutics, LLC

Study Description
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Brief Summary:
Recently, the Tdap (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis) vaccination was added to the list of immunizations associated with lower incidence of dementia. Plasma-based biomarkers for AD are a welcome alternative to expensive and invasive testing for Alzheimer's; these biomarkers include assessment of amyloid and tau and neurofilament light protein that assesses non-specific neurodegeneration. The investigators will test for these biomarkers, as well as some immune parameters, administer Tdap then repeat the blood tests in six months.

Condition or disease Intervention/treatment Phase
Alzheimer Disease, Late Onset Biological: tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine Phase 1 Phase 2

Detailed Description:
A growing number of studies have consistently shown reduced incident risk of dementia associated with a variety of vaccinations. Most recently, data probes of medical claims from two large and disparate databases showed that vaccination for tetanus, diphtheria and pertussis (Tdap) was associated with a 42% decrease in dementia. Adult vaccination coverage remains low for most routinely recommended vaccines, including Tdap. This study will screen and qualify participants who do not meet the recommended frequency interval for Tdap vaccination. Participants will have consented to a review of their medical history (including vaccination history), a neurocognitive test and a battery of blood tests. Included in the blood testing will be plasma-based testing for amyloid, tau and neurofilament light protein. The study will be considered a pilot study; it will be an open-label trial. All participants will receive a single dose of the Tdap vaccine. Nine months after vaccination, participants will repeat the pre-vaccine blood tests. Primary objective will be the assessment of change in the Alzheimer's disease (AD) biomarkers. Bordetella pertussis (B. pertussis), the bacterium that causes whopping cough, is one of the targets of the Tdap vaccine. B. pertussis is a hypothesized infectious trigger of Alzheimer's disease (AD). A secondary objective of the study will be determination of present and past infection by B. pertussis via IgG testing as well as PCR of nasal swab and how this may relate to the Alzheimer biomarker responses to Tdap vaccination.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: single group assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Tdap Vaccination and Plasma Biomarkers of Alzheimer's Disease
Estimated Study Start Date : May 1, 2023
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : March 31, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Tdap
Open label study, no placebo comparator
 Biological: tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine
Tdap is a combination vaccine that protects against three potentially life-threatening bacterial diseases: tetanus, diphtheria, and pertussis (whooping cough).
Other Name: Tdap


Outcome Measures
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Primary Outcome Measures :
  1. Change in Plasma Amyloid [ Time Frame: start of study and 6 months ]
    Amyloid peptides 42/40 ratio

  2. Change in Plasma Tau [ Time Frame: start of study and 6 months ]
    a brain-specific protein that may be expected to leak from brain interstitial fluid to the plasma compartment in Alzheimer's disease as well as its preclincial and prodromal stages.


Secondary Outcome Measures :
  1. Presence of B. pertussis [ Time Frame: start of study and 6 months ]
    Nasal swab for the presence of B. pertussis

  2. B. pertussis IgG [ Time Frame: start of study ]
    Blood test for history of B. pertussis


Eligibility Criteria
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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:

  • Immuno- competent
  • Out of compliance for Tdap vaccine (none within 10 years).
  • Ability of give informed consent.
  • SAGE test 17 or greater

Exclusion Criteria:

  • Immuno- compromised
  • In compliance for Tdap vaccination (within 10 years).
  • Known allergy to components of the Tdap vaccine.
  • SAGE test <17
Contacts and Locations
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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): NCT05183516


Contacts
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Contact: Coad T Dow, MD 715-577-5656 ctomdow@gmail.com
Contact: Alie Halverson, CNA 715-456-7336 info@mindfuldt.com

Locations
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United States, Wisconsin
Mindful Diagnostics and Therapeutics
Eau Claire, Wisconsin, United States, 54701-3016
Sponsors and Collaborators
Mindful Diagnostics and Therapeutics, LLC
Infectious Disease Society of America
Investigators
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Principal Investigator: Coad T Dow, MD Mindful Diagnostics and Therapeutics
More Information
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Publications of Results:

Other Publications:

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Responsible Party: Mindful Diagnostics and Therapeutics, LLC
ClinicalTrials.gov Identifier: NCT05183516    
Other Study ID Numbers: Tdap PANDA
First Posted: January 10, 2022    Key Record Dates
Last Update Posted: August 25, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No participant data will be shared with other researchers.

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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.: No
Keywords provided by Mindful Diagnostics and Therapeutics, LLC:
Tdap
Alzheimer's
biomarkers
B. pertussis
immune risk profile
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