Clinical Trials Logo

Clinical Trial 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.

Clinical Trial 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

Related Conditions & MeSH terms

NCT number NCT05183516
Study type Interventional
Source Mindful Diagnostics and Therapeutics, LLC
Contact Coad T Dow, MD
Phone 715-577-5656
Email [email protected]
Status Not yet recruiting
Phase Phase 1/Phase 2
Start date May 1, 2022
Completion date March 31, 2023

See also
  Status Clinical Trial Phase
Completed NCT02958930 - Safety and Efficacy of Transcranial Electromagnetic Treatment Against Alzheimer's Disease N/A
Completed NCT04449926 - BCG and Plasma Amyloid in Non-Demented Adults Phase 2
Active, not recruiting NCT03661034 - Study of Tolerability, Safety and Efficacy of Sensory Stimulation at Multiple Dose Levels to Improve Brain Function (Etude Study) N/A
Recruiting NCT04263194 - Network-based rTMS in Alzheimer's Disease N/A
Recruiting NCT04100889 - A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Alzheimer's Disease
Completed NCT02187276 - The Predictive Factors of Good Clinical Response to Cholinesterase Inhibitors in Alzheimer Disease and Mixed Dementia N/A
Recruiting NCT04680013 - Genetic Studies in Familial Dementia
Recruiting NCT04270474 - Reducing Risk of Dementia Through Deprescribing N/A
Recruiting NCT03149380 - Effectiveness of Alzheimer's Universe (Www.AlzU.Org) on Knowledge and Behavior N/A
Recruiting NCT03653156 - China Cognition and Aging Study
Completed NCT03300726 - Synaptic Injury and Functional Connectivity in Alzheimer's Disease
Recruiting NCT01773915 - New Proteins in Body Fluids as Potential Biomarker for Alzheimer's Disease: a Pilot Study N/A
Recruiting NCT05138848 - Time-in-bed Restriction in Older Adults With Sleep Difficulties With and Without Risk for Alzheimer's Disease N/A
Recruiting NCT03153371 - Early-onset Alzheimer's Disease Phenotypes: Neuropsychology and Neural Networks
Active, not recruiting NCT03927040 - Transcranial Electromagnetic Treatment Against Alzheimer's Disease N/A