NCT05183516

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started May 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 21, 2021

Completed
20 days until next milestone

First Posted

Study publicly available on registry

January 10, 2022

Completed
1.3 years until next milestone

Study Start

First participant enrolled

May 1, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2024

Completed
Last Updated

August 25, 2022

Status Verified

August 1, 2022

Enrollment Period

8 months

First QC Date

December 21, 2021

Last Update Submit

August 22, 2022

Conditions

Alzheimer Disease, Late Onset

Keywords

TdapAlzheimer'sbiomarkersB. pertussisimmune risk profile

Outcome Measures

Primary Outcomes (2)

  • Change in Plasma Amyloid

    Amyloid peptides 42/40 ratio

    start of study and 6 months

  • Change in Plasma Tau

    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.

    start of study and 6 months

Secondary Outcomes (2)

  • Presence of B. pertussis

    start of study and 6 months

  • B. pertussis IgG

    start of study

Study Arms (1)

Tdap

EXPERIMENTAL

Open label study, no placebo comparator

Biological: tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine

Interventions

tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccineBIOLOGICAL

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

Also known as: Tdap
Tdap

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mindful Diagnostics and Therapeutics

Eau Claire, Wisconsin, 54701-3016, United States

Location

Related Publications (4)

  • 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.

    PMID: 33856020BACKGROUND

  • 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.

    PMID: 27692981BACKGROUND

  • 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.

    PMID: 34897645BACKGROUND

  • 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.

    PMID: 33933117RESULT

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Tetanus Toxoid

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

ToxoidsVaccinesBiological ProductsComplex Mixtures

Study Officials

  • Coad T Dow, MD

    Mindful Diagnostics and Therapeutics

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Coad T Dow, MD

CONTACT

715-577-5656ctomdow@gmail.com

Alie Halverson, CNA

CONTACT

715-456-7336info@mindfuldt.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: single group assignment
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 21, 2021

First Posted

January 10, 2022

Study Start

May 1, 2023

Primary Completion

December 31, 2023

Study Completion

March 31, 2024

Last Updated

August 25, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

No participant data will be shared with other researchers.

Locations

US(1)