Biomarker Extension for Participants Who Were Previously in XanADu
Research type
Research Study
Full title
A Non-interventional Biomarker Analysis Extension Protocol for Participants Who Were Previously Enrolled in XanADu: A Phase 2, Double-Blind, 12-Week, Randomised, Placebo-Controlled Study to Assess the Safety, Tolerability, and Efficacy of Xanamem™ in Subjects with Mild Dementia due to Alzheimer’s Disease (AD)
IRAS ID
317054
Contact name
Martin Johnson
Contact email
Sponsor organisation
Actinogen Medical
Clinicaltrials.gov Identifier
Universal Trial Number:, U1111-1177-5932
Duration of Study in the UK
0 years, 1 months, 0 days
Research summary
In this extension to the XanADu study, we would like to re-test some of the blood samples that were obtained during the XanADu study to measure levels of a group of biomarker proteins. The additional tests, not available when the XanADu study was underway, will only be performed on the baseline sample, and the one obtained after 12 weeks of treatment.
The retrospective testing of blood biomarkers has two main purposes. Firstly, to see if some biomarkers are present in patients with mild dementia due to AD. Secondly, to see what effect Xanamem has on these biomarkers.
The blood samples collected during the original XanADu study were re-identifiable. This means that the participant's name was removed when they were taken and given a participant code number (psuedoanonymised).
The code numbers will now be recoded to a different randomly assigned number and the association between the original "participant code number" and the new code number will be broken. This means we will not be able to track backwards from the newly coded sample to the original study sample(s) or data, making the newly coded samples fully anonymised.
Due to Covid-19 and staff re-deployment, the previous samples had not been destroyed, thereby allowing further limited testing is possible, prior to formal and final sample destruction.REC name
South Central - Berkshire B Research Ethics Committee
REC reference
22/SC/0238
Date of REC Opinion
5 Jul 2022
REC opinion
Favourable Opinion