FLUTEMETAMOL (18F) for Alzheimer's disease|Progressive supranuclear palsy|Frontotemporal dementia|Corticobasal degeneration|Mild cognitive impairment

Inclusion criteria

• {"criterion_text":"- Healthy elderly subjects - No cognitive symptoms reported by study participant"}
• {"criterion_text":"- Healthy elderly subjects - Normal performance on cognitive tests"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- Mild cognitive impairment/dementia - Cognitive symptoms reported by patient and/or informant"}
• {"criterion_text":"- 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)"}
• {"criterion_text":"- Mild cognitive impairment/dementia- General cognition and functional performance fulfilling a diagnosis of dementia at the time of the baseline visit (Dementia group)"}
• {"criterion_text":"- All - Between 20 and 100 years of age"}
• {"criterion_text":"- All - Fluent in Swedish"}
• {"criterion_text":"- All - Agrees to at least one lumbar puncture, MRI scan of the brain and neuropsychological testing."}

Exclusion criteria

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

Primary endpoints

• {"endpoint_text":"- Detection of specific signal of 18F-RO6958948 or 18F-Flutemetamol in patients with neurodegenerative disease or healthy volunteers.","definition_or_measurement_approach":""}

Secondary endpoints

• {"endpoint_text":"- 18F-RO6958948 or 18F-Flutemetamol PET brain:cerebellar uptake ratios measured with a priori VOI analysis in subjects with neurodegenerative disease compared to healthy volunteers","definition_or_measurement_approach":"PET brain:cerebellar uptake ratios measured with a priori VOI analysis"}
• {"endpoint_text":"- Associations of 18F-RO6958948 or 18F-Flutemetamol brain uptake ratios measured by VOI analysis with other diagnostic methods, including CSF biomarkers, cognitive tests and MRI findings","definition_or_measurement_approach":"Correlation/association analyses between VOI PET uptake ratios and CSF biomarkers, cognitive test results and MRI findings"}
• {"endpoint_text":"- Regional differences in distribution of 18F-RO6958948 or 18FFlutemetamol brain uptake between different neurodegenerative disease conditions","definition_or_measurement_approach":"Regional PET uptake comparisons between disease conditions (regional distribution analysis)"}

Sweden

Earliest CTIS Part Ii Submission Date

10-07-2024

Latest Decision Or Authorization Date

18-09-2024

Processing Time Days

70

Number Of Sites

1

Number Of Participants

2450

Primary sponsor

Full Name

Region Skane

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Sweden

Third parties

• {"country":"United States","full_name":"General Electric Ltd. United States","duties_or_roles":"Source of monetary support","organisation_type":""}
• {"country":"Switzerland","full_name":"Hoffman La Roche Ltd. Switzerland","duties_or_roles":"Source of monetary support","organisation_type":""}