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The Swedish BioFINDER - Preclinical AD Study

StatusRecruiting
PhaseNot specified
Started
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Record History

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  1. Interventions: Flutemetamol F18 Injection (Diagnostic Test), Magnetic resonance imaging (MRI) (Diagnostic Test), Plasma Ab42/Ab40 (Diagnostic Test)… to Flutemetamol F18 Injection (Diagnostic Test), Magnetic resonance imaging (MRI) (Diagnostic Test), Plasma tau (Diagnostic Test), Plasma…
    • Eligibility criteria expanded, about 10 words
    • Secondary endpoints revised (4)
    v5
  2. Re-verified, no change to tracked fieldsv4
  3. Primary and study completion dates: Dec 31, 2025 to Dec 31, 2026
    • Enrollment target: 600 to 800
    v3
  4. Primary endpoints revised (2)
    • Interventions: Flutemetamol F18 Injection (Diagnostic Test), MRI (Diagnostic Test), Plasma Ab42/Ab40 (Diagnostic Test), Plasma tau (Diagnostic Test)… to Flutemetamol F18 Injection (Diagnostic Test), Magnetic resonance imaging (MRI) (Diagnostic Test), Plasma Ab42/Ab40 (Diagnostic Test)…
    • Eligibility criteria expanded, about 17 words
    v2
  5. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This research study aims to examine biomarkers of Alzheimer's disease (AD) as early as possible which could potentially be a screening tool for the general population. This observational study will take place at the Skåne University Hospital in Sweden. The study will enroll up to 600 cognitively healthy subjects aged 50 to 80 years with 3/4 having preclinical Alzheimer's disease. Recruitment and enrollment will be ongoing for 2-3 years, and subject participation will be lasting approximately 4 years. Disclosure of AD risk assessments will be an optional procedure.
Trial Details
NCT Number NCT06121544
Lead Sponsor Skane University Hospital
Collaborators: Lund University
Conditions
(from sponsor)		 Alzheimer Disease, Mild Cognitive Impairment, Mild Dementia
Related terms Alzheimer Disease, Cognitive Dysfunction, Disease
Enrollment 800 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov