Alzheimer’s Disease Biomarker Consortium – Down Syndrome (ABC-DS)
Research type
Research Study
Full title
Alzheimer’s Disease Biomarker Consortium – Down Syndrome (ABC-DS)
IRAS ID
299603
Contact name
Shahid Zaman
Contact email
Sponsor organisation
University of Cambridge, Department of Psychiatry
Duration of Study in the UK
5 years, 4 months, 1 days
Research summary
Cognitive functions (including thinking, concentration and memory) are brain functions that decline in almost all adults with Down syndrome (DS) who are in their forties or above leading to mild cognitive impairment (MCI-DS) or dementia of Alzheimer’s disease (AD). It takes several years for the disease to manifest clinically by which time it may be too late to prevent or treat the dementia. It is necessary to characterise the biological and behavioural/psychological changes that occur in a large cohort during the clinically silent ‘pre-symptomatic,’ and the sub-clinical ‘prodromal’ phases as it would allow the prediction of disease trajectories in given individuals and facilitate the development of outcome measures for clinical trials for prevention.
The ABC-DS is an international (USA and UK) consortium study designed to characterise the natural history of AD and MCI-DS in adult participants with DS (ages 25+) who are otherwise well (except for a minority with early signs of AD or MCI-DS). They will be invited for assessments to the Clinical Performance sites (all based in the USA and only one outside the USA) every 16 months over 5-years designed to identify cognitive, blood, CSF (cerebrospinal fluid or spinal fluid), and brain/eye imaging markers for predicting the onset and progression of MCI-DS and dementia. We also include a small number of healthy non-DS sibling participants as controls. The procedures performed at each assessment cycle include a medical/neurological evaluation, cognitive assessments, informant/carer questionnaires, MRI (magnetic resonance imaging) and PET (positron emission tomography) scans, peripheral blood sample draw, and for some spinal tap or lumbar puncture (LP) for cerebrospinal fluid. The aim is to characterize over time (longitudinally) change in biological, cognitive, psychological, behavioural and day-to-day functioning and skills to classify participants into groups based on pre-clinical and clinical status and to predict outcomes and develop measures for clinical trials.REC name
Wales REC 5
REC reference
21/WA/0365
Date of REC Opinion
17 Dec 2021
REC opinion
Further Information Favourable Opinion