TRIal designs for DElivery of Novel Therapies for Neurodegeneration

Cardiff University0 sites22 target enrollmentApril 4, 2018

Overview

2021 Protocol article in https://pubmed.ncbi.nlm.nih.gov/33543141/ protocol (added 08/02/2021)

Registry

who.int

Start Date

April 4, 2018

End Date

February 28, 2023

Last Updated

last year

Study Type

Interventional

Sex

All

Sponsor

•1\. Confirmed diagnosis of HD through genetic testing (CAG\=39\)
•2\. \=18 years of age
•3\. Stage I or II disease (assessed using the Total Functional Capacity Scale with a score equal to 12 or below) and diagnosed as having motor onset
•4\. Participant is ambulatory

•1\. People without capacity to consent to the trial
•2\. Any ongoing major psychiatric disorder that would preclude the ability to take part in functional assessments and the ability to give informed consent
•3\. Lack of carer, significant other or family member to support attendance at regular assessments.
•Exclusion criteria for the surgical intervention are:
•4\. Participants on any long\-term anticoagulant medication (to include aspirin, warfarin, clexane)
•5\. Any significant medical condition that would compromise the safety of anaesthesia and/ or surgery including; Q\-T interval prolongation, torsades des pointes or ventricular arrhythmia
•6\. Participants not deemed to be suitable for transplant surgery (e.g. inadequate striatal volume on MRI)
•7\. Pregnancy and breastfeeding
•Added 31/07/2019: 8\. Previous immunizing event such as blood transfusion or previous transplant
•9\. Contraindications to 3T MRI (such as a fitted pacemaker)