Alzheimer's Disease
Conditions
Interventions
Product Code: [18F]RO6958948
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Not yet available
Current Sponsor code: [18F]RO6958948
Other descriptive name: [18F]RO948
Concentration un
Sponsors
BarcelonaBeta Brain Research Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Signature of the study informed consent form approved by the corresponding authorities. 2. Men and women that have participated in a BBRC-sponsored study, including the ALFA project (STUDY 45-65 FPM/2012), the ALFA+ cohort study (ALFA – FPM – 0311), the ALFAcognition study (ALFAcognition/BBRC2017) or the Barcelona?eta Dementia Prevention Research Clinic study (BBRC-DemPrev-2018). 3. Participants with an available cerebral MRI (magnetic resonance imaging) in the last 12 months not suggestive of radiological incidental findings constituting an exclusion criterion. 4. Known cognitive status based on the cognitive workup of the BBRC-sponsored studies specified above. Cognitive status should have been determined within the last 12 months. 5. Known A? and tau status. 6. Good knowledge of the language and being literate. 7. Female participants should be post-menopausal or present a negative pregnancy test at the moment of PET acquisition. 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 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: 1. Presence of clinically relevant psychiatric disorder according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-V) criteria: major depressive disorder, generalized anxiety disorder, schizophrenia and bipolar disorder, as assessed in the BBRC-sponsored studies specified above. 2. Individuals with visual and/or hearing impairment. 3. History of encephalitis, ictus or seizures excluding feverish convulsions during childhood, as assessed in the BBRC-sponsored studies specified above. 4. Severe cerebral macrovascular (i.e., multi-stroke) disease or brain tumour (metastasis/brain cancer) as verified by MRI. 5. Previous participation in a clinical study involving an investigational pharmaceutical product within 30 days prior to screening and/or administration of a radiopharmaceutical within 10 radioactive half-lives prior to study drug administration in this study. 6. Clinically relevant renal or hepatic insufficiency. 7. Any other clinically important condition that may jeopardize the study or be dangerous for the participant. 8. Active drug or alcohol abuse, as assessed in the BBRC-sponsored studies specified above. 9. Previous intolerance to PET studies or known hypersensitivity to 18F-RO6958948. 10. Being pregnant or breast-feeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The overall objective of the present study is to characterize tau tracer retention as a function of amyloid levels transversally and longitudinally. 1 Cross sectional objectives ? To measure 18F-RO6958948 retention in selected participants of BBRC ALFA-related studies as a function of amyloid levels. ? To study the relation between 18F-RO6958948 retention and amyloid levels. 2 Longitudinal objectives ? To measure tau accumulation and spreading in participants of the ALFA-related studies of BBRC as a function of baseline amyloid levels. ? To study the dynamic relation between tau spreading and amyloid levels longitudinally.;Secondary Objective: 1 Cross sectional objectives ? To characterize imaging correlates as a function of tau and amyloid levels. ? To study the role of tau retention on cognitive performance. ? To define predictors of tau retention. 2 Longitudinal objectives ? To define predictors of tau spreading.;Primary end point(s): Global and regional retention rate of 18F-RO6958948.;Timepoint(s) of evaluation of this end point: Cross-sectionally at baseline visit of all subjects; Longitudinally at the end of the trial. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1 Cross sectional variables ? Brain MRI acquisition: a. MRI-based volumetry of different brain regions b. Voxel-based study of brain volumetry c. Resting-state functional connectivity of the default mode network ? Neuropsychological Tests;Timepoint(s) of evaluation of this end point: Cross-sectionally at baseline visit of all subjects; Longitudinally at the end of the trial. | — |
Countries
Spain
Contacts
Public ContactClinical Operations Manager
BarcelonaBeta Brain Research Center
Outcome results
None listed