Alzheimer's Disease
Conditions
Interventions
Trade Name: Neuraceq
Product Name: Neuraceq
Product Code: PRD1617296
Pharmaceutical Form: Solution for injection
Trade Name: Vizamyl
Product Name: Vizamyl
Pharmaceutical Form: Solution for injection
Sponsors
Stichting VUmc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Current or former participants of a Sponsor-approved PC, not demented, and older than 50 years of age will be eligible if they provide separate written informed consent to participate in the AMYPAD PNHS. 2. Participants with a suitable baseline biomarker, cognitive and risk factor profile, as determined by the Selection and Feasibility Committee, based on an adaptive selection algorithm that aims to provide optimal representation of the probability spectrum for AD risk; OR participants that have been randomly selected to maintain a mandated non-disclosure policy. 3. Participants who are assessed by the recruiting investigator to be physically fit to undergo PET scanning and able to tolerate the PET scanning procedure for at least the duration of a static scan (20 minutes). 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 1200 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 800
Exclusion criteria
Exclusion criteria: 1. Participants in whom PET scanning or magnetic resonance imaging (MRI) are contraindicated. 2. Participants who are not able to complete the study procedures as judged by the investigator. 3. Participants who have known hypersensitivities to the active ingredients of [18F]flutemetamol and [18F]florbetaben, or the excipients for both products (listed in section 6.1 of the respective Summary of Product Characteristics [SPC]). 4. Women of childbearing potential who are pregnant, planning to become pregnant, lactating, or do not follow the contraceptive methods recommended by the Clinical Trial Facilitation Group
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the value of quantitative PET amyloid imaging measures for predicting progression within an AD risk probability spectrum (derived from four different dimensions: cognition, other biomarkers, traditional genetic and environmental risk factors and temporal changes in these dimensions) based on quantitative PET amyloid imaging measures, with or without other biomarkers.;Secondary Objective: • To evaluate the value of quantitative PET amyloid imaging, with or without other biomarkers, to predict 1) cognitive decline, 2) brain atrophy, and 3) functional decline. • To compare regional and global quantitative PET amyloid imaging measures with CSF amyloid measures for their ability to identify participants most likely to experience cognitive decline. • To assess the relationship between continuous measures of amyloid and 1) cognitive decline; and 2) clinical outcome assessments. • To determine the agreement between the classifications of brain amyloid status based on quantitative measures and visual interpretation of PET images. • To compare the ability of classifications (quantitative or visual) of brain amyloid status for predicting cognitive decline. • To determine the optimal methodology for the quantification of amyloid load by PET in both a cross-sectional and a longitudinal context ;Primary end point(s): Primary Variables 1. Composite Centiloid, SUVR and/or BPND values measured from [18F]flutemetamol or [18F]florbetaben PET images 2. Change from baseline in a composite score comprising measures of cognitive status and daily functioning, modifiable risk factors, and MRI measures of brain atrophy ;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): Secondary Variables: 1. Change from baseline in measures of cognitive status (e.g. RBANS Total Scale Index Score) 2. Change from baseline in MRI measures of brain atrophy 3. Change from baseline in measures of daily functioning 4. Change from baseline in measures of modifiable risk factors 5. Regional SUVR and/or BPND values at baseline 6. Change from baseline in Centiloid, SUVR and BPND values (global and/or regional) 7. Baseline R1 values from dynamic scans 8. Change from baseline in R1 values from dynamic scans 9. Threshold values of Centiloid, SUVR and/or BPND for negative/positive amyloid status that produce the greatest agreement with visual interpretation by a trained nuclear physician or radiologist 10. Threshold values of Centiloid, SUVR and/or BPND for negative/positive/grey-zone amyloid status that produce the highest accuracy with respect to predicting cognitive decline (and/or brain atrophy as measured by MRI) ;Timepoint(s) of evaluation of this end point: Cross-sectionally at baseline visit of all subjects; Longitudinally at the end of the trial. | — |
Countries
Belgium, France, Germany, Italy, Netherlands, Spain, Sweden, Switzerland, United Kingdom
Contacts
Public ContactVUmc
Stichting VUmc
Outcome results
None listed