Tdap and Biomarkers of Alzheimer's Disease

NCT ID: NCT05183516

Last Updated: 2022-08-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-01
• Study Completion Date: 2024-03-31

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.

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.

Conditions

Alzheimer Disease, Late Onset

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Tdap

Open label study, no placebo comparator

Group Type: EXPERIMENTAL

tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine

Intervention Type: BIOLOGICAL

Tdap is a combination vaccine that protects against three potentially life-threatening bacterial diseases: tetanus, diphtheria, and pertussis (whooping cough).

Interventions

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).

Intervention Type: BIOLOGICAL

Other Intervention Names

Tdap

Eligibility 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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Infectious Disease Society of America

UNKNOWN

Sponsor Role: collaborator

Mindful Diagnostics and Therapeutics, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Coad T Dow, MD

Role: PRINCIPAL_INVESTIGATOR

Mindful Diagnostics and Therapeutics

Locations

Mindful Diagnostics and Therapeutics

Eau Claire, Wisconsin, United States

Countries

United States

Central Contacts

Coad T Dow, MD

Role: CONTACT

ctomdow@gmail.com

715-577-5656

Alie Halverson, CNA

Role: CONTACT

info@mindfuldt.com

715-456-7336

References

Scherrer JF, Salas J, Wiemken TL, Jacobs C, Morley JE, Hoft DF. Lower Risk for Dementia Following Adult Tetanus, Diphtheria, and Pertussis (Tdap) Vaccination. J Gerontol A Biol Sci Med Sci. 2021 Jul 13;76(8):1436-1443. doi: 10.1093/gerona/glab115.

Reference Type: BACKGROUND

PMID: 33856020 (View on PubMed)

Rubin K, Glazer S. The pertussis hypothesis: Bordetella pertussis colonization in the pathogenesis of Alzheimer's disease. Immunobiology. 2017 Feb;222(2):228-240. doi: 10.1016/j.imbio.2016.09.017. Epub 2016 Sep 28.

Reference Type: BACKGROUND

PMID: 27692981 (View on PubMed)

Wiemken TL, Salas J, Morley JE, Hoft DF, Jacobs C, Scherrer JF. Comparison of rates of dementia among older adult recipients of two, one, or no vaccinations. J Am Geriatr Soc. 2022 Apr;70(4):1157-1168. doi: 10.1111/jgs.17606. Epub 2021 Dec 12.

Reference Type: BACKGROUND

PMID: 34897645 (View on PubMed)

West T, Kirmess KM, Meyer MR, Holubasch MS, Knapik SS, Hu Y, Contois JH, Jackson EN, Harpstrite SE, Bateman RJ, Holtzman DM, Verghese PB, Fogelman I, Braunstein JB, Yarasheski KE. A blood-based diagnostic test incorporating plasma Abeta42/40 ratio, ApoE proteotype, and age accurately identifies brain amyloid status: findings from a multi cohort validity analysis. Mol Neurodegener. 2021 May 1;16(1):30. doi: 10.1186/s13024-021-00451-6.

Reference Type: RESULT

PMID: 33933117 (View on PubMed)

Other Identifiers

Tdap PANDA

Identifier Type: -

Identifier Source: org_study_id