Alzheimer DiseaseSEABIRDNCT03899844
Study to Evaluate Amyloid in Blood and Imaging Related to Dementia
An observational study of Alzheimer Disease and Alzheimer Dementia, run by Washington University School of Medicine at 1 site in United States.
Trial summary
The purpose of this study is to determine how well a blood test can detect amyloid beta, a protein involved in Alzheimer's disease. Participants will be asked to complete an initial blood collection and cognitive testing, and a subset of participants will be asked to complete a larger blood collection, amyloid PET… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Alzheimer Disease, Alzheimer Dementia
- What is being tested?
- Blood collection, PiB PET/MRI, and cognitive testing
- How many people
- 1,122 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Apr 2019to 31 Jan 2024
- Phase
- Observational
- 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 60 years and older
- All sexes
- Adult, Older adult
Study population: Participants will be recruited from clinics and communities throughout the greater St. Louis metropolitan area.
Who may be able to join
- 1. At least 60 years of age
Who cannot join
- Unable to perform one or more activities of daily living (eating, bathing, dressing, ambulating, toileting) due to cognitive impairment or dependent on others due to cognitive impairment.
- Body weight of <100 pounds
- Active infectious disease (e.g., HIV, hepatitis B, hepatitis C)
- Bleeding disorder
- Taking an experimental drug for AD
- Blood donation in the last two months
- Blood transfusion in the last three months
- On hospice
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: Blood Amyloid-Beta Relationship With Amyloid Plaques and CSF Amyloid-Beta
The purpose of this study is to determine how well a blood test can detect amyloid beta, a protein involved in Alzheimer's disease. Participants will be asked to complete an initial blood collection and cognitive testing, and a subset of participants will be asked to complete a larger blood collection, amyloid PET imaging, and an MRI.
Read the detailed description
Alzheimer's disease is the most common cause of dementia and currently has no disease-modifying treatments or simple, accurate diagnostic tests. Amyloid beta builds up in the brain and forms plaques in people with Alzheimer's disease, and the buildup of this protein is found decades before symptoms of dementia begin. A blood test may be able to quickly and inexpensively screen people for Alzheimer's disease clinical trials and eventually diagnose Alzheimer's disease in the clinic.
- Conditions
- Alzheimer Disease, Alzheimer Dementia
- Being tested
- Blood collection, PiB PET/MRI, and cognitive testing
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood collection, PiB PET/MRI, and cognitive testingOther
Blood and imaging results will be analyzed for amyloid beta. Cognitive testing will be performed to determine clinical and cognitive status.
| Study group | Role | What they receive |
|---|---|---|
| Cognitively normal | 896 of the 1120 enrolled will not exhibit subjective impairment as defined by a brief clinical test. These participants will complete an initial blood collection and cognitive testing, and a subset of participants will be asked to return for a larger blood collection, amyloid (PiB) PET imaging, and MRI. Receives: Other: Blood collection, PiB PET/MRI, and cognitive testing | |
| Cognitively impaired | 224 of the 1120 enrolled will exhibit subjective impairment as defined by a brief clinical test. These participants will complete an initial blood collection and cognitive testing, and a subset of participants will be asked to return for a larger blood collection, amyloid (PiB) PET imaging, and MRI. Receives: Other: Blood collection, PiB PET/MRI, and cognitive testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma amyloid-beta 42/40 ratio
Measured: Baseline
Plasma amyloid-beta 42/40 ratio
Measured: 6 months
Area under the curve (AUC) of the blood test (plasma amyloid-beta 42/40 ratio) in predicting amyloid PET status
Measured: 6 months
Secondary outcomes (1)
Coefficient of variation for the initial and confirmatory blood amyloid-beta test results
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2019
- Study start9 Apr 2019
- Primary completion29 Jan 2024
- Study completion31 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Randall Bateman, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03899844
- Sponsor's protocol ID
- 201902081
- Acronym
- SEABIRD
- Status last verified
- Feb 2024
- First submitted
- 22 Mar 2019
- Last updated
- 13 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data which documents, supports and validates research findings will be made available after the main findings from the final research data set have been accepted for publication. Such research data will be de-identified to prevent the disclosure of personal identifiers.
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Amyloid-Beta Relationship With Amyloid Plaques and CSF Amyloid-Beta
- ClinicalTrials.gov ID
- NCT03899844
- Acronym / sponsor ID
- SEABIRD / 201902081
- Conditions
- Alzheimer Disease, Alzheimer Dementia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,122 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 9 Apr 2019 (actual)
- Primary completion
- 29 Jan 2024 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 2 Apr 2019 (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.
The purpose of this study is to determine how well a blood test can detect amyloid beta, a protein involved in Alzheimer's disease. Participants will be asked to complete an initial blood collection and cognitive testing, and a subset of participants will be asked to complete a larger blood collection, amyloid PET imaging, and an MRI.
Detailed description
Alzheimer's disease is the most common cause of dementia and currently has no disease-modifying treatments or simple, accurate diagnostic tests. Amyloid beta builds up in the brain and forms plaques in people with Alzheimer's disease, and the buildup of this protein is found decades before symptoms of dementia begin. A blood test may be able to quickly and inexpensively screen people for Alzheimer's disease clinical trials and eventually diagnose Alzheimer's disease in the clinic.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitively normal | – | Other: Blood collection, PiB PET/MRI, and cognitive testing896 of the 1120 enrolled will not exhibit subjective impairment as defined by a brief clinical test. These participants will complete an initial blood collection and cognitive testing, and a subset of participants will be asked to return for a larger blood collection, amyloid (PiB) PET imaging, and MRI. |
| Cognitively impaired | – | Other: Blood collection, PiB PET/MRI, and cognitive testing224 of the 1120 enrolled will exhibit subjective impairment as defined by a brief clinical test. These participants will complete an initial blood collection and cognitive testing, and a subset of participants will be asked to return for a larger blood collection, amyloid (PiB) PET imaging, and MRI. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Participants will be recruited from clinics and communities throughout the greater St. Louis metropolitan area.
Key inclusion criteria (1 listed)
- 1. At least 60 years of age
Key exclusion criteria (8 listed)
- Unable to perform one or more activities of daily living (eating, bathing, dressing, ambulating, toileting) due to cognitive impairment or dependent on others due to cognitive impairment.
- Body weight of <100 pounds
- Active infectious disease (e.g., HIV, hepatitis B, hepatitis C)
- Bleeding disorder
- Taking an experimental drug for AD
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 |
|---|---|---|
| Blood collection, PiB PET/MRI, and cognitive testingBlood and imaging results will be analyzed for amyloid beta. Cognitive testing will be performed to determine clinical and cognitive status. | Other | Cognitively impaired, Cognitively normal |
Primary outcome
Plasma amyloid-beta 42/40 ratio
Time frame: Baseline
Plasma amyloid-beta 42/40 ratio
Time frame: 6 months
Area under the curve (AUC) of the blood test (plasma amyloid-beta 42/40 ratio) in predicting amyloid PET status
Time frame: 6 months
1 secondary outcome
Coefficient of variation for the initial and confirmatory blood amyloid-beta test results
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2024.
- Individual participant dataSharing planned: Yes. Individual participant data which documents, supports and validates research findings will be made available after the main findings from the final research data set have been accepted for publication. Such research data will be de-identified to prevent the disclosure of personal identifiers.
Related trials for Alzheimer Disease
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Not yet recruiting
Acupressure as Long-term Intervention to Slow the Progression of Early/Mild Alzheimer's Disease
Alzheimer's Disease
RecruitingObservational study
Effectiveness and Safety of Disease-Modifying Therapy for Alzheimer's Disease: A Multicenter Retrospective Study
Alzheimer's Disease (AD)
RecruitingPhase 3
A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-1)
Alzheimer Disease
RecruitingPhase 3
A Study of Trontinemab in Cognitively Unimpaired Individuals at Risk for Progression to Symptomatic Alzheimer's Disease
Alzheimer's 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.
Randall Bateman, MD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer Disease and Alzheimer Dementia, run by Washington University School of Medicine 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 1 inclusion and 8 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: finished, as of the sponsor's last update on 13 Feb 2024. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma amyloid-beta 42/40 ratio (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Feb 2024.