Alzheimer DiseaseNCT05457998
BioFINDER-Brown: Examination of Alzheimer's Disease Biomarkers
An observational study of Alzheimer Disease and Mild Cognitive Impairment, run by Butler Hospital at 1 site in United States.
Trial summary
This research study aims to examine biomarkers of Alzheimer's disease as early as possible which could potentially be a screening tool for the general population. This observational study will take place at the Memory and Aging Program at Butler Hospital. 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, Mild Cognitive Impairment, Dementia
- What is being tested?
- Flutemetamol F18 Injection, [18F]-RO6958948 Injection and [18F]-MK-6240 Injection
- Type of treatment
- Injection or infusion
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jun 2023to Jun 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: This study will be conducted in up to 200 subjects between the ages of 50-80 who are cognitively unimpaired. Participants must also pass all inclusion/exclusion criteria.
Who may be able to join
- Individuals between the ages of 50 and 80 years old (inclusive)
- Score of 16 or above on the MoCA telephone
- Score of 27 or greater on the MMSE for individuals aged 50 to 64 years old or a score of 26 or greater for individuals aged 65 to 80 years old
- Participants in the 50-60 age range will additionally need to meet at least one of the following: (1) First degree family history of dementia with onset before age 75; (2) APOE e4 allele carrier; or (3) Prior elevated result on amyloid PET or amyloid CSF testing
- Conversationally fluent in English to the extent that an interpreter is not necessary for comprehension of the study information, procedures, and cognitive tests.
- If participants elect to participate in the optional disclosure procedure, they will be required to have an appropriate study partner who agrees to participate in the study and who is intellectually, visually, and auditory capable, and conversationally fluent in English to the extent that an interpreter is not necessary.
- Adequate visual and auditory acuity to allow neuropsychological testing.
- Participants must be willing and able to provide written informed consent.
Who cannot join
- Diagnosis of mild cognitive impairment or dementia
- History of significant brain injury or other known neurologic disease or insult, resulting in lasting cognitive sequelae that would confound the assessment and staging of potential neurodegenerative disease (e.g., Huntington's disease, Parkinson's disease, Parkinsonism due to multiple system atrophy (MSA), progressive supranuclear palsy (PSP), Shy Drager Syndrome (SDS) or other neuro-degenerative dementias, encephalitis or other brain infection, epilepsy or stroke with lasting impairment to cognitive function).
- Current serious or unstable systemic illness or organ failure that, in the PI's judgement, would make it difficult to participate in the study (e.g., such as terminal cancer, cardiovascular, hepatic, renal, gastroenterological, respiratory, endocrinologic, neurologic, psychiatric, immunologic, or hematologic disease or other conditions ). History of cancer is acceptable with at least one year in remission with a good prognosis.
- Individuals with clinically significant depression, bipolar disorder, anxiety, or suicidal ideations within the past year as defined by the most current version of the Diagnostic and Statistical Manual of Mental Disorders (DSM).
- A history of schizophrenia as defined by the most current version of the DSM.
- History within the past year of chronic alcohol or drug abuse/dependence as defined by the most current version of the DSM.
Show all 9Show fewer
- Marijuana use is acceptable, but frequent users will be asked to abstain from use within 24 hours of any assessments.
- Refusing or unable to complete any study procedures.
- Currently enrolled in another study which involves clinical drug trial or other medical intervention.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Butler Hospital Memory and Aging Program
Providence, Rhode Island, 02906
About this study
This research study aims to examine biomarkers of Alzheimer's disease as early as possible which could potentially be a screening tool for the general population. This observational study will take place at the Memory and Aging Program at Butler Hospital. The study will enroll up to 200 cognitively healthy subjects aged 50 to 80 years with ongoing recruitment and enrollment for 2 years, and subject participation lasting approximately 4 years. Disclosure of AD risk assessments will be an optional procedure. Two PET imaging sub-studies will also be optional.
- Conditions
- Alzheimer Disease, Mild Cognitive Impairment, Dementia
- Being tested
- Flutemetamol F18 Injection, [18F]-RO6958948 Injection, [18F]-MK-6240 Injection
- Keywords
- Early diagnosis, Biomarker, PET, MRI, β-amyloid, tau, Cognitive test
- Medical subject headings
- Alzheimer Disease, Cognitive Dysfunction, Dementia, Disease, Pick Disease of the Brain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flutemetamol F18 InjectionDiagnostic test
Also called Vizamyl
PET imaging of Abeta amyloid
[18F]-RO6958948 InjectionDiagnostic test
PET imaging of Tau aggregates
[18F]-MK-6240 InjectionDiagnostic test
PET imaging of Tau aggregates
| Study group | Role | What they receive |
|---|---|---|
| Main study population: Cognitively unimpaired individuals (50-80 y) | Participants will be enrolled based on a predetermined ratio of Alzheimer's Disease plasma and PET biomarker risk levels (e.g., as P-tau217 and amyloid PET).
FOLLOW-UP FOR 4 YEARS: Cognitive testing, blood draws and retinal imaging will be conducted at baseline and 12 months. Cognitive testing and blood draws will be conducted at 24 months and 36 months.
MRI and amyloid PET scans will be performed at screening/baseline and 24 months. An additional amyloid PET scan will be performed at 48 months. Receives: Diagnostic Test: Flutemetamol F18 Injection | |
| Sub-group 1: Optional Tau PET imaging sub-study | An optional tau PET imaging sub-study will be conducted in 70 subjects from the main study population who elect to participate.
If enrolled in the optional tau PET imaging sub-study, participants will have three tau PET scans with [18F]RO-948: at baseline, 24 months, and 48 months. Receives: Diagnostic Test: [18F]-RO6958948 Injection | |
| Sub-group 2: Optional Tau PET tracer comparison sub-study | An optional tau PET tracer comparison sub-study will be conducted in 30 subjects from the main study population who elect to participate.
Tau PET scans with 2 tracers ([18F]RO-948 and [18F]MK-6240) will be performed at baseline and 24 months. An additional Tau PET scan with [18F]RO-948 will be performed at 48 months. Receives: Diagnostic Test: [18F]-RO6958948 Injection; Diagnostic Test: [18F]-MK-6240 Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of change in plasma biomarkers
Validate and assess longitudinal changes from baseline in plasma amyloid, phosphorylated tau (p-tau) and other fluid biomarkers (e.g., neurofilament light).
Measured: Time zero equals the baseline visit. All subjects will subsequently attend follow-up visits every year for 4 years after baseline.
Rate of change in cerebral amyloid pathology
Longitudinal assessment of cerebral amyloidosis based on amyloid PET imaging.
Measured: Time Frame: Time zero equals the baseline visit. All subjects will subsequently attend follow-up visits every year for 5 years after baseline.
Rate of change in Tau PET measures
Longitudinal assessment of cerebral tau accumulation based on tau PET imaging.
Measured: Time zero equals the baseline visit. All subjects will subsequently attend follow-up visits every year for 4 years after baseline.
Secondary outcomes (4)
Rate of cognitive decline as measured by traditional cognitive and behavioral assessments
Measured: Time zero equals the baseline visit. All subjects will subsequently attend follow-up visits every year for 4 years after baseline.
Rate of cognitive decline as measured by digital cognitive assessments
Measured: Time zero equals the baseline visit. All subjects will subsequently attend follow-up visits every year for 4 years after baseline.
Rate of change in retinal imaging metrics
Measured: Time zero equals the baseline visit. All subjects will subsequently attend follow-up visits every year for 4 years after baseline.
Rate of change in psychological wellness as measured by the Geriatric Depression Scale
Measured: Time zero equals the baseline visit. All subjects will subsequently attend follow-up visits every year for 4 years after baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2022
- Study start14 Jun 2023
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (estimated)
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.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Butler Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Warren Alpert Foundation, Brown University, University of Rhode Island, Hoffmann-La Roche, Eli Lilly and Company, GE Healthcare
- Responsible party
- Principal investigator, Edward Huey, Butler Hospital
- Investigators
- Edward Huey, MD, Principal investigator, Butler Hospital Memory and Aging Program
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05457998
- Sponsor's protocol ID
- 1745146
- Status last verified
- Dec 2024
- First submitted
- 11 Jul 2022
- Last updated
- 17 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BioFINDER-Brown: Examination of Alzheimer's Disease Biomarkers
- ClinicalTrials.gov ID
- NCT05457998
- Acronym / sponsor ID
- 1745146
- Conditions
- Alzheimer Disease, Mild Cognitive Impairment, Dementia
- Keywords
- Early diagnosis, Biomarker, PET, MRI, β-amyloid, tau, Cognitive test
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Butler HospitalUniversity, hospital or other
- Collaborators
- The Warren Alpert Foundation, Brown University, University of Rhode Island, Hoffmann-La Roche, Eli Lilly and Company, GE Healthcare
- Study start
- 14 Jun 2023 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 14 Jul 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.
This research study aims to examine biomarkers of Alzheimer's disease as early as possible which could potentially be a screening tool for the general population. This observational study will take place at the Memory and Aging Program at Butler Hospital. The study will enroll up to 200 cognitively healthy subjects aged 50 to 80 years with ongoing recruitment and enrollment for 2 years, and subject participation lasting approximately 4 years. Disclosure of AD risk assessments will be an optional procedure. Two PET imaging sub-studies will also be optional.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Main study population: Cognitively unimpaired individuals (50-80 y) | – | Diagnostic Test: Flutemetamol F18 InjectionParticipants will be enrolled based on a predetermined ratio of Alzheimer's Disease plasma and PET biomarker risk levels (e.g., as P-tau217 and amyloid PET). FOLLOW-UP FOR 4 YEARS: Cognitive testing, blood draws and retinal imaging will be conducted at baseline and 12 months. Cognitive testing and blood draws will be conducted at 24 months and 36 months. MRI and amyloid PET scans will be performed at screening/baseline and 24 months. An additional amyloid PET scan will be performed at 48 months. |
| Sub-group 1: Optional Tau PET imaging sub-study | – | Diagnostic Test: [18F]-RO6958948 InjectionAn optional tau PET imaging sub-study will be conducted in 70 subjects from the main study population who elect to participate. If enrolled in the optional tau PET imaging sub-study, participants will have three tau PET scans with [18F]RO-948: at baseline, 24 months, and 48 months. |
| Sub-group 2: Optional Tau PET tracer comparison sub-study | – | Diagnostic Test: [18F]-RO6958948 Injection, Diagnostic Test: [18F]-MK-6240 InjectionAn optional tau PET tracer comparison sub-study will be conducted in 30 subjects from the main study population who elect to participate. Tau PET scans with 2 tracers ([18F]RO-948 and [18F]MK-6240) will be performed at baseline and 24 months. An additional Tau PET scan with [18F]RO-948 will be performed at 48 months. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This study will be conducted in up to 200 subjects between the ages of 50-80 who are cognitively unimpaired. Participants must also pass all inclusion/exclusion criteria.
Key inclusion criteria (8 listed)
- Individuals between the ages of 50 and 80 years old (inclusive)
- Score of 16 or above on the MoCA telephone
- Score of 27 or greater on the MMSE for individuals aged 50 to 64 years old or a score of 26 or greater for individuals aged 65 to 80 years old
- Participants in the 50-60 age range will additionally need to meet at least one of the following: (1) First degree family history of dementia with onset before age 75; (2) APOE e4 allele carrier; or (3) Prior elevated result on amyloid PET or amyloid CSF testing
- Conversationally fluent in English to the extent that an interpreter is not necessary for comprehension of the study information, procedures, and cognitive tests.
Key exclusion criteria (9 listed)
- Diagnosis of mild cognitive impairment or dementia
- History of significant brain injury or other known neurologic disease or insult, resulting in lasting cognitive sequelae that would confound the assessment and staging of potential neurodegenerative disease (e.g., Huntington's disease, Parkinson's disease, Parkinsonism due to multiple system atrophy (MSA), progressive supranuclear palsy (PSP), Shy Drager Syndrome (SDS) or other neuro-degenerative dementias, encephalitis or other brain infection, epilepsy or stroke with lasting impairment to cognitive function).
- Current serious or unstable systemic illness or organ failure that, in the PI's judgement, would make it difficult to participate in the study (e.g., such as terminal cancer, cardiovascular, hepatic, renal, gastroenterological, respiratory, endocrinologic, neurologic, psychiatric, immunologic, or hematologic disease or other conditions ). History of cancer is acceptable with at least one year in remission with a good prognosis.
- Individuals with clinically significant depression, bipolar disorder, anxiety, or suicidal ideations within the past year as defined by the most current version of the Diagnostic and Statistical Manual of Mental Disorders (DSM).
- A history of schizophrenia as defined by the most current version of the DSM.
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 |
|---|---|---|
| Flutemetamol F18 InjectionAlso: VizamylPET imaging of Abeta amyloid | Diagnostic test | Main study population: Cognitively unimpaired individuals (50-80 y) |
| [18F]-RO6958948 InjectionPET imaging of Tau aggregates | Diagnostic test | Sub-group 1: Optional Tau PET imaging sub-study, Sub-group 2: Optional Tau PET tracer comparison sub-study |
| [18F]-MK-6240 InjectionPET imaging of Tau aggregates | Diagnostic test | Sub-group 2: Optional Tau PET tracer comparison sub-study |
Primary outcome
Rate of change in plasma biomarkers
Time frame: Time zero equals the baseline visit. All subjects will subsequently attend follow-up visits every year for 4 years after baseline.
Validate and assess longitudinal changes from baseline in plasma amyloid, phosphorylated tau (p-tau) and other fluid biomarkers (e.g., neurofilament light).
Rate of change in cerebral amyloid pathology
Time frame: Time Frame: Time zero equals the baseline visit. All subjects will subsequently attend follow-up visits every year for 5 years after baseline.
Longitudinal assessment of cerebral amyloidosis based on amyloid PET imaging.
Rate of change in Tau PET measures
Time frame: Time zero equals the baseline visit. All subjects will subsequently attend follow-up visits every year for 4 years after baseline.
Longitudinal assessment of cerebral tau accumulation based on tau PET imaging.
4 secondary outcomes
Rate of cognitive decline as measured by traditional cognitive and behavioral assessments
Time frame: Time zero equals the baseline visit. All subjects will subsequently attend follow-up visits every year for 4 years after baseline.
Rate of cognitive decline as measured by digital cognitive assessments
Time frame: Time zero equals the baseline visit. All subjects will subsequently attend follow-up visits every year for 4 years after baseline.
Rate of change in retinal imaging metrics
Time frame: Time zero equals the baseline visit. All subjects will subsequently attend follow-up visits every year for 4 years after baseline.
Rate of change in psychological wellness as measured by the Geriatric Depression Scale
Time frame: Time zero equals the baseline visit. All subjects will subsequently attend follow-up visits every year for 4 years after baseline.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2024.
- Individual participant dataSharing planned: Undecided
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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.
Edward Huey, MD principal investigator
Butler Hospital Memory and Aging Program
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 Mild Cognitive Impairment, run by Butler Hospital 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 8 inclusion and 9 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: enrolling by invitation, as of the sponsor's last update on 17 Dec 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?
This study is still under way. Results are not available in the source record yet.
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?
Rate of change in plasma biomarkers (time frame: Time zero equals the baseline visit. All subjects will subsequently attend follow-up visits every year for 4 years after 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 17 Dec 2024.