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The BioFINDER 2 study - improved diagnostics and increased understanding of the pathophysiology of cognitive disorders
EU CTIS ID: 2024-511842-38-00
What this study is testing
Study the diagnostic accuracy of Tau PET (18F-RO6958948) and Vizamyl (18F-Flutemetamol) for identifying healthy elderly individuals and patients with subjective or objective mild cognitive symptoms who are at high risk of subsequent development of dementia due to Alzheimer's disease (AD) or other neurodegenerative disorders.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Healthy elderly subjects - No cognitive symptoms reported by study participant
- Healthy elderly subjects - Normal performance on cognitive tests
- Healthy elderly subjects - 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
- Mild cognitive impairment/dementia - Cognitive symptoms reported by patient and/or informant
- Mild cognitive impairment/dementia - 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 (MCI)
- Mild cognitive impairment/dementia- General cognition and functional performance fulfilling a diagnosis of dementia at the time of the baseline visit (Dementia group)
You likely can't join if
- All - Major depression as described in DSM-IV
- All - History of schizophrenia or other recurrent psychotic disorder
- All - History of alcohol or substance abuse or dependence within the past 5 years
- All - Diseases that will make study participation difficult, such as terminal cancer or significant heart failure
- All - Certain neurologic diseases, such as Huntington's disease, normal pressure hydrocephalus, brain tumor, subdural hematoma, multiple sclerosis, or persistent neurologic deficits or known structural brain abnormalities
See the full eligibility criteria
- Healthy elderly subjects - No cognitive symptoms reported by study participant
- Healthy elderly subjects - Normal performance on cognitive tests
- Healthy elderly subjects - 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
- Mild cognitive impairment/dementia - Cognitive symptoms reported by patient and/or informant
- Mild cognitive impairment/dementia - 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 (MCI)
- Mild cognitive impairment/dementia- General cognition and functional performance fulfilling a diagnosis of dementia at the time of the baseline visit (Dementia group)
- All - Between 20 and 100 years of age
- All - Fluent in Swedish
- All - Agrees to at least one lumbar puncture, MRI scan of the brain and neuropsychological testing.
- All - Major depression as described in DSM-IV
- All - History of schizophrenia or other recurrent psychotic disorder
- All - History of alcohol or substance abuse or dependence within the past 5 years
- All - Diseases that will make study participation difficult, such as terminal cancer or significant heart failure
- All - Certain neurologic diseases, such as Huntington's disease, normal pressure hydrocephalus, brain tumor, subdural hematoma, multiple sclerosis, or persistent neurologic deficits or known structural brain abnormalities
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.