Trial-Ready Cohort - Down syndrome (TRC-DS)
Research type
Research Study
Full title
Alzheimer’s Clinical Trial Consortium for Down Syndrome (ACTC-DS) - Trial-Ready Cohort - Down Syndrome (TRC-DS)
IRAS ID
299192
Contact name
Andre Strydom
Contact email
Sponsor organisation
King's College London
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 7 months, 1 days
Research summary
Down’s syndrome (DS) occurs in 1 in 800 to 1000 live births and is caused by having three copies of chromosome 21 instead of the usual two. This has serious consequences for the health of people with DS, including an increased risk for Alzheimer’s disease (AD). This is most likely due to people with DS having an extra copy of the APP gene, which is located on chromosome 16, causing an over-production of “beta-amyloid” (A-beta) protein and resulting in AD. Almost all people with DS develop brain tissue changes in specific parts of the brain – deposits of tau and A-beta proteins – that characterise the pathology of AD. Preliminary data show that adults with DS exhibit significant changes in AD-related biomarkers between the ages of 35-55. It is also within this age range that AD-related cognitive decline and dementia typically manifest in DS. AD is the primary cause of death in adults with DS over the age of 35, highlighting the pressing need for the inclusion of individuals with DS in clinical trials for AD. We will enrol 10 adults with DS (ages 35-55) into a Trial Ready Cohort (TRC) to study several outcome measures (biomarker and cognitive) and establish their feasibility for use in AD therapeutic clinical trials in people with DS. Across all 15 international TRC-DS sites, the aim is to recruit 120 non-demented adults with DS (ages 35-55) into the TRC-DS in order to determine longitudinal cognitive, clinical and biomarker trajectories. The study will be conducted at King's College London, Institute of Psychiatry, Psychology and Neuroscience. Participants will be seen predominantly at the King's College Hospital Clinical Research Facility. The study will recruit until August 2021 and participants will come in for three visits over 16 months.
REC name
Wales REC 5
REC reference
22/WA/0181
Date of REC Opinion
22 Jun 2022
REC opinion
Unfavourable Opinion