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| Name | Class |
|---|---|
| The Warren Alpert Foundation | UNKNOWN |
| Brown University | OTHER |
| University of Rhode Island | OTHER |
| Hoffmann-La Roche |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Flutemetamol F18 Injection | Diagnostic Test | PET imaging of Abeta amyloid |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 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 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 zero equals the baseline visit. All subjects will subsequently attend follow-up visits every year for 4 years after baseline. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of cognitive decline as measured by traditional cognitive and behavioral assessments | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Edward Huey, MD | Butler Hospital Memory and Aging Program | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Butler Hospital Memory and Aging Program | Providence | Rhode Island | 02906 | United States |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D060825 | Cognitive Dysfunction |
| D003704 | Dementia |
| D004194 | Disease |
| D020774 | Pick Disease of the Brain |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
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| INDUSTRY |
| Eli Lilly and Company | INDUSTRY |
| GE Healthcare | INDUSTRY |
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Blood plasma
| [18F]-RO6958948 Injection | Diagnostic Test | PET imaging of Tau aggregates |
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| [18F]-MK-6240 Injection | Diagnostic Test | PET imaging of Tau aggregates |
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| 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 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 zero equals the baseline visit. All subjects will subsequently attend follow-up visits every year for 4 years after baseline. |
| D019636 |
| Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D003072 | Cognition Disorders |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D057180 | Frontotemporal Dementia |
| D057174 | Frontotemporal Lobar Degeneration |