The BioFINDER 2 study - improved diagnostics and increased understanding of the underlying mechanisms of cognitive disorders

Phase 1

• Conditions: eurodegenerative disorders with Tau-pathology; including, but not limited to, Alzheimers disease, progressive supranuclear palsy,frontotemporal dementia, corticobasal degeneration and mild cognitive impairment.; MedDRA version: 19.1Level: PTClassification code 10053643Term: Neurodegenerative disorderSystem Organ Class: 10029205 - Nervous system disorders; MedDRA version: 19.1Level: PTClassification code 10012267Term: DementiaSystem Organ Class: 10029205 - Nervous system disorders; MedDRA version: 19.1Level: PTClassification code 10067889Term: Dementia with Lewy bodiesSystem Organ Class: 10029205 - Nervous system disorders; MedDRA version: 19.1Level: HLGTClassification code 10028037Term: Movement disorders (incl parkinsonism)System Organ Class: 10029205 - Nervous system disorders; MedDRA version: 19.1Level: PTClassification code 10012271Term: Dementia Alzheimer's typeSystem Organ Class: 10029205 - Nervous system disorders; MedDRA version: 19.1Level: HLTClassification code 10001897Term: Alzheimer's disease (incl subtypes)System Organ Class: 10029205 - Nervous system disorders; MedDRA version: 19.1Level: LLTClassification code 10009846Term: Cognitive impairmentSystem Organ Class: 10029205 - Nervous system disorders; MedDRA version: 19.1Level: LLTClassification code 10048598Term: Cognitive disordersSystem Organ Class: 10029205 - Nervous system disorders

• Registration Number: EUCTR2017-000094-36-SE
• Lead Sponsor: Skåne University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-30
• Last Update Posted: 22 May 2017

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Healthy elderly subjects
- No cognitive symptoms reported by study participant
- 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 20 and 100 years of age
- Fluent in Swedish
- Agrees to at least one lumbar puncture, MRI scan of the brain and neuropsychological testing.

Mild cognitive impairment/dementia
- Cognitive symptoms reported by patient and/or informant
- Between 20 and 100 years of age
- 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)
- General cognition and functional performance fulfilling a diagnosis of dementia at the time of the baseline visit (Dementia group)
- Fluent in Swedish
- Agrees to at least one lumbar puncture, MRI scan of the brain and neuropsychological testing.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 400
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 900

Exclusion Criteria

Exclusion Criteria:
- Major depression as described in DSM-IV.
- History of schizophrenia or other recurrent psychotic disorder
- History of alcohol or substance abuse or dependence within the past 5 years
- Diseases that will make study participation difficult, such as terminal cancer or significant heart failure.
- 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified