An observational study in Alzheimer Disease, Mild Cognitive Impairment and Dementia, sponsored by Butler Hospital. Enrolling by invitation at 1 site in United States. Open to participants aged 50 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-17.
Sponsored by Butler Hospital · Observational
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.
3,765 studies on the registry are indexed under Alzheimer Disease; 881 are open to participants now.
This study's planned enrollment of 200 is close to the median of 200 across 780 observational studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →Butler Hospital is the lead sponsor of 118 studies on the registry; 13 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Diagnostic Test: Flutemetamol F18 Injection
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.
Diagnostic Test: [18F]-RO6958948 Injection
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.
Diagnostic Test: [18F]-RO6958948 Injection · Diagnostic Test: [18F]-MK-6240 Injection
PET imaging of Abeta amyloid
Also known as: Vizamyl
PET imaging of Tau aggregates
PET imaging of Tau aggregates
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).
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 cerebral amyloid pathology
Longitudinal assessment of cerebral amyloidosis based on amyloid PET imaging.
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.
Rate of change in Tau PET measures
Longitudinal assessment of cerebral tau accumulation based on tau PET imaging.
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 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.
Plan to share: Undecided
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.