NCT01208675Completed
The Swedish BioFINDER Study
The Swedish BioFINDER Study: Early Diagnosis of Alzheimer's Disease - a Multidisciplinary Approach
Source: ClinicalTrials.gov · Last updated 27 Apr 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 1150 (actual)
- First submitted
- 23 Sept 2010
- Start date
- Sept 2010
- Primary completion date
- Dec 2024
- Lead sponsor
- Skane University Hospital
- Diseases
- Lewy body dementia, Alzheimer disease
- NCT number
- NCT01208675
What you commit to
- Study type: Observational
- Participants enrolled: 1150
- From Sept 2010 to the primary completion date, Dec 2024
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Any significant neurologic disease other than dementia disorders, such as Huntington's disease, normal pressure hydrocephalus, brain tumor, seizure disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma followed by persistent neurologic defaults or known structural brain abnormalities.
- History of schizophrenia or other recurrent psychotic disorder
- History of alcohol or substance abuse or dependence within the past 5 years
Other
- Major depression as described in DSM-IV.
Who the study is looking for
- Healthy elderly subjects
- No cognitive symptoms reported by patient and/or informant
- Normal performance on cognitive tests
- General cognition and functional performance preserved such that a diagnosis of MCI or dementia cannot be made by physician at the time of the baseline visit
- Between 60 and 90 years of age
- Fluent in Swedish
- Agrees to at least one lumbar puncture, and neuropsychological testing.
- Mild cognitive impairment
- Cognitive symptoms reported by patient and/or informant
- Between 60 and 80 years of age
- Mini-Mental State Exam score between 24 and 30
- General cognition and functional performance sufficiently preserved such that a diagnosis of dementia cannot be made by physician at the time of the baseline visit
- Fluent in Swedish
- Agrees to at least one lumbar puncture, and neuropsychological testing.
Age in the registry: 60 years to 80 years · Sex: All · Accepts healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Memory Clinic, Hospital of Ängelholm Coordinator of this site? Confirm its status | Ängelholm | Sweden | Unknown status |
| Memory Clinic, Skåne University Hospital Coordinator of this site? Confirm its status | Malmö | Sweden | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.