NCT05457998
BioFINDER-Brown: Examination of Alzheimer's Disease Biomarkers
Enrolling by Invitation
Not specifiedAges 50–80ObservationalButler HospitalInvestigator-initiated
~200 participants
Updated 2024-12-17 on ClinicalTrials.gov
What's tested:Flutemetamol F18 Injection[18F]-RO6958948 Injection[18F]-MK-6240 Injection
At a glance
Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Rate of change in plasma biomarkers
Measured over Time zero equals the baseline visit. All subjects will subsequently attend follow-up visits every year for 4 years after baseline.
+2 more outcomes measured
Conditions
Where it's being run
1 sites across 1 statesRhode Island1
Study leadership
- Edward Huey, MD · PRINCIPAL_INVESTIGATOR · Butler Hospital Memory and Aging Program
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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.
Exclusion
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.
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.
What this trial measures
- Rate of change in plasma biomarkersTime 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 pathologyTime 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 measuresTime 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.