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ClinicalIndex Comparison Record
N/ACompleted· 1,150 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
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Search/NCT01208675
NCT01208675N/ACompleted

The Swedish BioFINDER Study: Early Diagnosis of Alzheimer's Disease - a Multidisciplinary Approach

Skane University Hospital·observational·Posted Sep 24, 2010·Updated Apr 27, 2025

In Brief

An observational study for Mild Cognitive Impairment and 3 related conditions. Completed, enrolled 1,150 participants across 2 sites.

Detailed Summary

The present study aims at combining biochemical methods with various types of imaging techniques to identify the pathophysiology of Alzheimer's disease (AD). The main interest is to find markers associated with the very early steps in the pathology of this disease. The investigators shall thus screen for i) molecules in cerebrospinal fluid (CSF) and plasma specific for AD, and ii) brain imaging markers (e.g. MRI and PET) that correlate to detailed clinical assessments. Biomarkers of interest would then be useful to: 1. Enable accurate detection of the disease early on. Such biomarkers need to specifically reflect the very early pathophysiology of AD and distinguish it from disorders with similar symptomatology, such as other types of dementia and major depression. The sensitivity and specificity of these biomarkers in combination with clinical assessment should be of at least 90%. 2. Enable prediction of the course of events of the disease, such as the disease rate in individual patients. Biomarkers that can predict the pattern of future symptoms will be extremely valuable. 3. Allow monitoring of early effects of new disease-modifying therapies (so-called surrogate biomarkers). Currently clinical therapeutic trials for AD require large patient groups together with long-term treatment. Both size of the groups and treatment time will be reduced with the help of surrogate biomarkers. 4. Study the pathogenesis of the disease. Biomarkers can be used to investigate in detail early alterations in AD patients. For instance, changes in the levels of certain molecules in CSF together with genetic predisposition could then be correlated to clinical signs and changes detectable by brain imaging. This can lead to identification of new therapeutic targets that could easily be monitored in future trials.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesSweden
CollaboratorsLund University

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedSep 24, 2010
Enrollment StartSep 1, 2010
Primary CompletionDec 1, 2024
TodayJul 2, 2026
Enrollment to primary: 14.3 yearsPosted 15.8 years ago