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

  233118

• Contact name

  Zuzana Walker

• Contact email

  z.walker@ucl.ac.uk

• 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

  Summary of Research
  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.

  Summary of results
  : A total of 840 participants (244 Subjective Cognitive Decline Plus, 341 Mild Cognitive Impairment and 255 Dementia) were enrolled. Sociodemographic/clinical features did not differ significantly among recruiting memory clinics or with previously reported cohorts. The randomisation assigned 355 participants to Arm 1, 32% to Arm 2 and 33% to Arm 3. Cognitive stages were distributed equally across the Arms. The features of AMYPAD-DPMS participants are as expected for a memory clinic population. This ensures the generalizability of future study results.

  Results are available on 5 publications. All published results are available in the journals, below are the links:

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  Please note: Not all results are available yet as there are still papers in preparation for publications.

• REC name

  London - Queen Square Research Ethics Committee

• REC reference

  18/LO/1436

• Date of REC Opinion

  5 Oct 2018

• REC opinion

  Favourable Opinion