AMYPAD Prognostic and Natural History Study (PNHS)
Research type
Research Study
Full title
AMYPAD Prognostic and Natural History Study (PNHS), an open label, prospective, multicentre, cohort study in individuals without dementia to evaluate the additional value of quantitative amyloid imaging in determining Alzheimer’s Disease (AD) dementia risk.
IRAS ID
230209
Contact name
Laura Doull
Contact email
Sponsor organisation
Stichting VUmc
Eudract number
2018-002277-22
Clinicaltrials.gov Identifier
EudraCT number, 2018-002277-22
Duration of Study in the UK
2 years, 10 months, 1 days
Research summary
Alzheimer's Disease (AD) is the most common cause of dementia worldwide, affecting 1 in 10 people aged 65 years or older. Certain brain changes have been associated with AD; however, the brain changes as we age, even in people who never develop dementia. The build-up of a protein called β-amyloid in the brain is believed to be one of the earliest detectable brain changes associated with AD development. Positron Emission Tomography (PET) is a type of scan which makes images of the brain. In this study, we'll use β-amyloid PET imaging to better understand the changes in the brain that are related to the development of AD dementia and identify people who are at increased risk of such a progression.
This study is a study linked to the European Prevention of Alzheimer’s Dementia Longitudinal Cohort Study (EPAD LCS), and will take place in up to 20 research centres in France, the Netherlands, Spain, Sweden, Switzerland, Germany, Denmark, Norway, Finland, Italy, Ireland, Belgium and the UK. We’re doing this study in up to 2000 participants, without dementia, from among the EPAD LCS participants. Participants will continue to have the procedures required for EPAD LCS and will have up to 2 amyloid PET scans as part of AMYPAD PNHS.
Participants will take up to 25 months to finish the study. They'll all have 1 screening visit and 1 study visit involving an amyloid PET scan. Half of the participants will then be invited back for a second study visit to have a second PET scan between 12-24 months after their first PET scan (Study Visit 1). For each PET scan, participants will receive a dose of radioactive tracer.REC name
Scotland A: Adults with Incapacity only
REC reference
18/SS/0142
Date of REC Opinion
19 Dec 2018
REC opinion
Favourable Opinion