(duplicate) AMYPAD WP3 - Diagnostic and Patient Management Study
Research type
Research Study
Full title
Multicentre, Open-label, Randomised Study to Assess the Diagnostic Value of Amyloid PET Imaging in Patients with Subjective Cognitive Decline Plus, Mild Cognitive Impairment, or Dementia Where Alzheimer’s Disease Is in the Differential Diagnosis (Diagnostic and Patient Management Study)
IRAS ID
257196
Contact name
Zuzana Walker
Contact email
Sponsor organisation
University of Geneva
Eudract number
2017-002527-21
Clinicaltrials.gov Identifier
2017-002527-21, EUDRACT
Duration of Study in the UK
3 years, 2 months, 3 days
Research summary
A protein called amyloid may accumulate in the brain as people get older and is more common in people who complain of memory problems. The accumulation of amyloid protein impairs communication between brain cells and is considered typical of Alzheimer’s Disease (AD). The presence of amyloid in the brain can be measured by positron emission tomography (PET) imaging using amyloid tracers. The main aim of this study is to find out if having an amyloid PET scan early on provides a better and more accurate diagnosis of cognitive impairment compared to having an amyloid PET scan later during the diagnostic process. In AD it has been demonstrated that having the combination of an amyloid PET scan with a clinical assessment allows for an earlier and more accurate AD diagnosis. Participants who consent to the study will be randomised into one of three groups. Group 1 will have a PET scan immediately after the first assessment, Group 2 will have a PET approximately 8 months later and Group 3 may have a PET scan at any time during the study, at the treating clinician’s discretion. In this study, two equivalent amyloid scans will be used, florbetaben (NeuraCeq) and flutemetamol (Vizamyl). Both scans are approved for clinical use in Europe. Patients will be eligible to take part in the study if they have either dementia where AD is a possible cause, mild cognitive impairment, or subjective cognitive decline plus.
REC name
Scotland A: Adults with Incapacity only
REC reference
19/SS/0013
Date of REC Opinion
28 Feb 2019
REC opinion
Favourable Opinion