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
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|Condition or disease||Intervention/treatment||Phase|
|Alzheimer Disease, Late Onset||Biological: tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||single group assignment|
|Masking:||None (Open Label)|
|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|
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
- Change in Plasma Amyloid [ Time Frame: start of study and 6 months ]Amyloid peptides 42/40 ratio
- 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.
- Presence of B. pertussis [ Time Frame: start of study and 6 months ]Nasal swab for the presence of B. pertussis
- B. pertussis IgG [ Time Frame: start of study ]Blood test for history of B. pertussis
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||50 Years to 80 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
- Immuno- competent
- Out of compliance for Tdap vaccine (none within 10 years).
- Ability of give informed consent.
- SAGE test 17 or greater
- Immuno- compromised
- In compliance for Tdap vaccination (within 10 years).
- Known allergy to components of the Tdap vaccine.
- SAGE test <17
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
|Contact: Coad T Dow, MDemail@example.com|
|Contact: Alie Halverson, CNAfirstname.lastname@example.org|
|United States, Wisconsin|
|Mindful Diagnostics and Therapeutics|
|Eau Claire, Wisconsin, United States, 54701-3016|
|Principal Investigator:||Coad T Dow, MD||Mindful Diagnostics and Therapeutics|
|Responsible Party:||Mindful Diagnostics and Therapeutics, LLC|
|Other Study ID Numbers:||
|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.|
|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|
immune risk profile
Late Onset Disorders
Central Nervous System Diseases
Nervous System Diseases