BioFINDER-Brown: Examination of Alzheimer's Disease Biomarkers

Part of paid clinical trials in Providence, Rhode Island.

Sponsor
Butler Hospital
Study ID
NCT05457998
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
50 Years - 80 Years
Healthy Volunteers
Accepted

Interventions

  • Flutemetamol F18 Injection — DIAGNOSTIC_TEST
    PET imaging of Abeta amyloid
  • [18F]-RO6958948 Injection — DIAGNOSTIC_TEST
    PET imaging of Tau aggregates
  • [18F]-MK-6240 Injection — DIAGNOSTIC_TEST
    PET imaging of Tau aggregates

Study Details

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.

Key Dates

Start date
Jun 14, 2023
Status verified
Dec 2024
Primary completion
Jun 30, 2028
Completion
Jun 30, 2028

Study Design

Enrollment
200 participants (estimated)

Arms

  • Arm: 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.
  • Arm: 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.
  • Arm: 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.

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. ]

Locations (1)

FacilityCityStateZIPSite coordinators
Butler Hospital Memory and Aging ProgramProvidenceRhode Island02906-

Find similar trials in Providence, RI

By condition
Alzheimer's disease
By specialty
NeurologyDementia careBrain disordersGeriatrics
By research site
Butler Hospital Memory and Aging Program· Providence, RI

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