AMYPAD Prognostic and Natural History Study
Not yet recruiting
- Conditions
- Alzheimer's disease, cognitive decline, Alzheimer's dementia, ziekte van Alzheimer's, dementie, cognitief achteruitgang
- Registration Number
- NL-OMON24549
- Lead Sponsor
- Stichting VUmc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 2000
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.
Exclusion Criteria
Exclusion Criteria:
1.Participants who are not currently active in the EPAD LCS.
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method „XPrimary Variables<br><br /><br>„XComposite Centiloid, SUVR and/or BPND values measured from [18F]flutemetamol or [18F]florbetaben PET images<br /><br><br>„XChange from baseline in a composite score comprising measures of cognitive status and daily functioning, modifiable risk factors, and MRI measures of brain atrophy<br>
- Secondary Outcome Measures
Name Time Method „XSecondary Variables<br /><br><br>„XChange from baseline in measures of cognitive status (e.g. RBANS Total Scale Index Score)<br /><br>„XChange from baseline in MRI measures of brain atrophy<br /><br>„XChange from baseline in measures of daily functioning<br /><br>„XChange from baseline in measures of modifiable risk factors<br /><br>„XRegional SUVR and/or BPND values at baseline<br /><br>„XChange from baseline in Centiloid, SUVR and BPND values (global and/or regional)<br /><br>„XBaseline R1 values from dynamic scans<br /><br>„XChange from baseline in R1 values from dynamic scans<br /><br>„XThreshold 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<br /><br>„XThreshold 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)<br>