Alzheimer Disease, Late OnsetPhase 1/2NCT05183516
Tdap and Biomarkers of Alzheimer's Disease
A Phase 1/2 study testing tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine in people with Alzheimer Disease, Late Onset, run by Mindful Diagnostics and Therapeutics, LLC at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease, Late Onset
- What is being tested?
- tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2023to 31 Mar 2024
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Immuno- competent
- Out of compliance for Tdap vaccine (none within 10 years).
- Ability of give informed consent.
- SAGE test 17 or greater
Who cannot join
- Immuno- compromised
- In compliance for Tdap vaccination (within 10 years).
- Known allergy to components of the Tdap vaccine.
- SAGE test <17
Trial locations and contacts
1 site in 1 country.
United States1 site
Mindful Diagnostics and Therapeutics
Eau Claire, Wisconsin, 54701-3016
About this study
Official title: Evaluation of Tdap Vaccination and Plasma Biomarkers of Alzheimer's Disease
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.
Read the 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
- Being tested
- tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine
- Keywords
- Tdap, Alzheimer's, biomarkers, B. pertussis, immune risk profile
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccineBiological
Also called Tdap
Tdap is a combination vaccine that protects against three potentially life-threatening bacterial diseases: tetanus, diphtheria, and pertussis (whooping cough).
| Study group | Role | What they receive |
|---|---|---|
| Tdap | Experimental | Open label study, no placebo comparator Receives: Biological: tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Plasma Amyloid
Amyloid peptides 42/40 ratio
Measured: 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.
Measured: start of study and 6 months
Secondary outcomes (2)
Presence of B. pertussis
Nasal swab for the presence of B. pertussis
Measured: start of study and 6 months
B. pertussis IgG
Blood test for history of B. pertussis
Measured: start of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2022
- Study start1 May 2023 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Alzheimer Disease, Late OnsetStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- single group assignment
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mindful Diagnostics and Therapeutics, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Infectious Disease Society of America
- Responsible party
- Sponsor
- Investigators
- Coad T Dow, MD, Principal investigator, Mindful Diagnostics and Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05183516
- Sponsor's protocol ID
- Tdap PANDA
- Status last verified
- Aug 2022
- First submitted
- 21 Dec 2021
- Last updated
- 25 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: No participant data will be shared with other researchers.
Publications
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.
PubMed 33856020Rubin 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.
PubMed 27692981Wiemken 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.
PubMed 34897645West 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.
PubMed 33933117
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Tdap Vaccination and Plasma Biomarkers of Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT05183516
- Acronym / sponsor ID
- Tdap PANDA
- Conditions
- Alzheimer Disease, Late Onset
- Keywords
- Tdap, Alzheimer's, biomarkers, B. pertussis, immune risk profile
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Mindful Diagnostics and Therapeutics, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Infectious Disease Society of America
- Study start
- 1 May 2023 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Mar 2024 (estimated)
- First posted
- 10 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- single group assignment
| Arm | Type | Receives |
|---|---|---|
| Tdap | Experimental | Biological: tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccineOpen label study, no placebo comparator |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Immuno- competent
- Out of compliance for Tdap vaccine (none within 10 years).
- Ability of give informed consent.
- SAGE test 17 or greater
Key exclusion criteria (4 listed)
- Immuno- compromised
- In compliance for Tdap vaccination (within 10 years).
- Known allergy to components of the Tdap vaccine.
- SAGE test <17
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccineAlso: TdapTdap is a combination vaccine that protects against three potentially life-threatening bacterial diseases: tetanus, diphtheria, and pertussis (whooping cough). | Biological | Tdap |
Primary outcome
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.
2 secondary outcomes
Presence of B. pertussis
Time frame: start of study and 6 months
B. pertussis IgG
Time frame: start of study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2022.
- Background: PubMed 33856020Scherrer 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.
- Background: PubMed 27692981Rubin 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.
- Background: PubMed 34897645Wiemken 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.
- Results publication: PubMed 33933117West 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.
- Individual participant dataSharing planned: No. No participant data will be shared with other researchers.
Related trials for Alzheimer Disease, Late Onset
RecruitingObservational study
Alzheimer's Disease Genetics Study
Alzheimer Disease, Late Onset Alzheimer Disease
RecruitingObservational study
Multimodal Assesment of Alzheimer Patients
Mild Cognitive Impairment, Alzheimer Disease, Late Onset
Recruiting
The BRidge Towards Implementation of Blood-based Biomarkers to Enable Early and Accurate Diagnosis of Alzheimer's Disease
Alzheimer Blood Biomarkers, Alzheimer's Disease (AD)
Active, not recruitingPhase 2
Allopregnanolone Regenerative Therapeutic for Mild Alzheimer's Disease
Alzheimer Dementia, Late Onset Alzheimer Disease
RecruitingObservational study
Late Onset Alzheimer's Disease
Alzheimer Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Coad T Dow, MD principal investigator
Mindful Diagnostics and Therapeutics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine in people with Alzheimer Disease, Late Onset, run by Mindful Diagnostics and Therapeutics, LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Coad T Dow, MD (715-577-5656, ctomdow@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Plasma Amyloid (time frame: start of study and 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05183516, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2022.