Neurodegenerative disorders with Tau-pathology
Conditions
Interventions
Product Name: 18F-AV-1451
Pharmaceutical Form: Injection
Sponsors
Skåne University Hospital, Region Skåne
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The healthy controls should fulfil the following criteria i) at least 60 years of age ii) no cognitive symptoms, iii) MMSE score 28-30, iv) do not fulfil the criteria of mild cognitive impairment or dementia; v) no significant neurological or psychiatric disorder. The patients with mild cognitive symptoms should fulfil the following criteria: i) at least 60 years of age ii) mild cognitive symptoms, iii) MMSE score 24-30, iv) do not fulfil the criteria of dementia. The patients clinically diagnosed with a “tauopathy” will be at least 50 years of age and they should fulfil the current clinical criteria of AD, FTD, PSP, CBD, PD, PDD, DLB, MSA or VaD. 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 140 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 450
Exclusion criteria
Exclusion criteria: The exclusion criteria of the present study are: - History of alcohol or substance abuse or dependence within the last five years. - Current major depressive disorder. - History of schizophrenia or other recurrent psychotic disorder. - Diseases that will make study participation difficult, such as metastatic cancer disease, severe renal or hepatic impairment or significant infectious disease. - Have received or participated in a trial with investigational medications in the past 30 days.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1) Main objective: To examine the efficacy of raised [18F]-AV-1451 brain uptake for detecting cerebral accumulation of Tau in patients with Alzheimer’s disease (AD), progressive supranuclear palsy (PSP), corticobasal degeneration (CBD) and frontotemporal dementia (FTD) and to study whether the regional distribution of raised [18F]-AV-1451 brain uptake differs between these disorders.;Secondary Objective: 2) To study whether raised regional [18F]-AV-1451 brain uptake can distinguish AD and/or FTD from other dementia disorders that are not characterised by Tau accumulation, including vascular dementia (VaD), Dementia with Lewy bodies (DLB) and Parkinson’s disease with dementia (PDD). 3) To study whether raised regional [18F]-AV-1451 brain uptake can distinguish PSP and/or CBD from other parkinsonian disorders that are not characterised by Tau accumulation, including Parkinson’s disease (PD) and multiple system atrophy (MSA). 4) To determine whether cognitively healthy elderly individuals or patients with mild cognitive symptoms, who exhibit raised [18F]-AV-1451 brain uptake, will develop AD in the future. ;Primary end point(s): Visual detection of [18F]-AV-1451 brain retention in patients compared to healthy volunteers ;Timepoint(s) of evaluation of this end point: After dosing and PET-scanning. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): [18F]-AV-1451 brain:cerebellar uptake ratios (SUVR) measured with a priori VOI analysis in patients compared to healthy volunteers. Associations of [18F]-AV-1451 brain uptake ratios (SUVR) measured by VOI analysis with other diagnostic methods, including CSF biomarkers, FDG PET and MRI findings. Change in [18F]-AV-1451 brain uptake ratios (SUVR) measured by VOI analysis over time in patients ;Timepoint(s) of evaluation of this end point: After dosing, PET-scanning and data analysis. | — |
Countries
Sweden
Contacts
Public ContactMemory Clinic
Skåne University Hospital, Region Skåne
Outcome results
None listed