A Phase 1/2 interventional study of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine in Alzheimer Disease, Late Onset, sponsored by Mindful Diagnostics and Therapeutics, LLC. Status unknown at 1 site in United States. Open to participants aged 50 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-08-25.
Sponsored by Mindful Diagnostics and Therapeutics, LLC · Phase 1/2, Interventional, and Treatment
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.
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.
3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.
This study's planned enrollment of 50 is below the median of 70 across 2,808 interventional studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →Mindful Diagnostics and Therapeutics, LLC is the lead sponsor of 2 studies on the registry; none are open to participants now.
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Exclusion Criteria:
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).
Also known as: Tdap
Change in Plasma Amyloid
Amyloid peptides 42/40 ratio
Time frame: 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.
Time frame: start of study and 6 months
Presence of B. pertussis
Nasal swab for the presence of B. pertussis
Time frame: start of study and 6 months
B. pertussis IgG
Blood test for history of B. pertussis
Time frame: start of study
Plan to share: No — No participant data will be shared with other researchers.
This study is status unknown, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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Mindful Diagnostics and Therapeutics, LLC