Alzheimer's disease, cognitive decline, Alzheimer's dementia, ziekte van Alzheimer's, dementie, cognitief achteruitgang
Conditions
Interventions
At least one amyloid PET imaging session, with the possibility of a follow-up scan between 12-24 months after baseline for 50% of participants.
Sponsors
Stichting VUmc
Eligibility
Inclusion criteria
Inclusion criteria: Baseline Eligibility Criteria 1. Participants who are currently active in the EPAD LCS 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 the mandated non-disclosure in EPAD LCS. 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). Follow-up Eligibility Criteria 1. Participants who underwent dynamic PET scanning at baseline: a. Participants who are willing and available to undergo a follow-up scan. All participants with a dynamic scan at baseline will be invited for follow-up scans. 2. Participants who underwent static PET scanning at baseline: a. Participants who are willing and available to undergo a follow-up scan, and b. Are selected based on the Selection and Feasibility Committee¡¦s algorithm for follow-up, which in addition to the previous algorithm also considers baseline composite SUVR values.
Exclusion criteria
Exclusion criteria: Exclusion Criteria: 1. Participants who are not currently active in the EPAD LCS. 2. Participants in whom PET scanning or magnetic resonance imaging (MRI) are contraindicated. 3. Participants who are not able to complete the study procedures as judged by the investigator. 4. 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]). 5. Women who are pregnant, planning to become pregnant, or lactating.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| „XPrimary Variables „XComposite Centiloid, SUVR and/or BPND values measured from [18F]flutemetamol or [18F]florbetaben PET images „XChange from baseline in a composite score comprising measures of cognitive status and daily functioning, modifiable risk factors, and MRI measures of brain atrophy | — |
Secondary
| Measure | Time frame |
|---|---|
| „X Secondary Variables „X Change from baseline in measures of cognitive status (e.g. RBANS Total Scale Index Score) „X Change from baseline in MRI measures of brain atrophy „X Change from baseline in measures of daily functioning „X Change from baseline in measures of modifiable risk factors „X Regional SUVR and/or BPND values at baseline „X Change from baseline in Centiloid, SUVR and BPND values (global and/or regional) „X Baseline R1 values from dynamic scans „X Change from baseline in R1 values from dynamic scans „X 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 „X 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) | — |
Outcome results
None listed