Dementia and cognitive impairment
Conditions
Interventions
Product Name: Flutemetamol (18F)
Pharmaceutical Form: Injection
Sponsors
Skånes universitetssjukhus
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Healthy elderly subjects (Nomas study) - 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 60 and 90 years of age - Fluent in Swedish - Agrees to at least one lumbar puncture, MRI scan of the brain and neuropsychological testing. Mild cognitive impairment (TiDiS study) - 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, 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 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 400
Exclusion criteria
Exclusion criteria: Exclusion Criteria (for both MCI and healthy elderly): - 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, seizure disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma followed by persistent neurologic defaults or known structural brain abnormalities.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To examine the efficacy of raised [18F]Flutemetamol brain uptake for differentiating subjects with mild cognitive impairment (MCI), who subsequently will develop Alzheimer’s disease (AD), from patients with MCI who will be cognitively stable or develop other dementias than AD.;Secondary Objective: To study whether raised [18F]Flutemetamol brain uptake is associated with other markers associated with prodromal AD, such as hippocampal atrophy, episodic memory dysfunction and cerebrospinal fluid biomarkers in patients with MCI. To specifically examine whether raised [18F]Flutemetamol brain uptake is associated with changes of monomeric and oligomeric forms of ß-amyloid in cerebrospinal fluid. To study the frequency of raised [18F]Flutemetamol brain uptake in cognitively healthy elderly individuals, with no signs of early AD. To determine whether cognitively healthy elderly individuals with raised [18F]Flutemetamol brain uptake will develop AD in the future. ;Primary end point(s): Visual Detection of Raised [18F] Flutemetamol Uptake in patients with mild cognitive impairment (MCI) or healthy volunteers (HV);Timepoint(s) of evaluation of this end point: after dosing | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): [18F] Flutemetamol brain:cerebellar uptake ratios measured with a priori VOI analysis in subjects with MCI compared to HV. Associations of [18F]Flutemetamol brain uptake rations measured by VOI analysis with other diagnostic methods, including CSF biomarkers, cognitive tests and MRI findings. ;Timepoint(s) of evaluation of this end point: after dosing | — |
Countries
Sweden
Contacts
Public ContactMinneskliniken
Skånes universitetssjukhus
Outcome results
None listed