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BioFINDER-Brown: Examination of Alzheimer's Disease Biomarkers

StatusEnrolling by Invitation
PhaseNot specified
Started
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Record History

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  1. Minor Trial status: Recruiting to Enrolling by Invitation
    • Site details revised
    v8
  2. Minor Eligibility criteria revisedv7
  3. Minor Primary and study completion dates: Mar 2028 to Jun 2028
    • Start date changed from estimate of May 2023 to Jun 14, 2023
    v6
  4. Notable Start date: Mar 2023 to May 2023v5
  5. Notable Trial status: Not Yet Recruiting to Recruitingv4 Show 4 more changesShow less
    • Study sites: 0 to 1
    • Primary and study completion dates: Dec 2027 to Mar 2028
    • Start date: Jan 2023 to Mar 2023
    • Interventions: Flutemetamol F18 Injection (Diagnostic Test), [18F]-GTP-1 Injection (Diagnostic Test), [18F]-MK-6240 Injection (Diagnostic Test)… to Flutemetamol F18 Injection (Diagnostic Test), [18F]-MK-6240 Injection (Diagnostic Test), [18F]-RO6958948 Injection (Diagnostic Test)
Show 2 earlier versionsHide 2 earlier versions
  1. Notable Start date: Nov 7, 2022 to Jan 2023
    • Primary and study completion dates: Nov 1, 2027 to Dec 2027
    v3
  2. Notable Start date: Sep 1, 2022 to Nov 7, 2022
    • Primary and study completion dates: Sep 1, 2027 to Nov 1, 2027
    • Eligibility criteria shortened, about 16 words
    v2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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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.
Trial Details
NCT Number NCT05457998
Lead Sponsor Butler Hospital
Collaborators: The Warren Alpert Foundation, Brown University, University of Rhode Island, Hoffmann-La Roche, Eli Lilly and Company, GE Healthcare
Conditions
(from sponsor)
Alzheimer Disease, Mild Cognitive Impairment, Dementia
Related terms Alzheimer Disease, Cognitive Dysfunction, Dementia, Disease, Pick Disease of the Brain
Enrollment 200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov