4704: TRANSCEND 1 An Observational Study in Parkinson's Disease
Research type
Research Study
Full title
TRANSCEND 1 - An observational study of patients with moderate Parkinson’s disease
IRAS ID
303513
Contact name
Roger Barker
Contact email
Sponsor organisation
Novo Nordisk Ltd
Clinicaltrials.gov Identifier
U1111-1254-1741, UTN
Duration of Study in the UK
1 years, 8 months, 16 days
Research summary
A non-interventional study in patients with moderate Parkinson's Disease. Eligible patients for TRANSCEND-1 may be potential candidates for a future interventional trial (TRANSCEND-2) which will evaluate transplantation of an experimental stem-cell based therapy called STEM-PD. The main objective of TRANSCEND-1 is to collect data on patients treated according to routine care. The secondary objective is to assess the patient’s interest in participating in TRANSCEND-2.
In TRANSCEND-1 patients will be approached in their usual Parkinson's Disease NHS clinic &/or they have already agreed to be contacted about future research. They will be provided with written and verbal information about the study and given as much time as they need to consider participation. Subjects who consent to participate will attend a screening visit. Eligible subjects will participate for between 13 and 104 weeks depending on whether (and how soon) they progress to participate in TRANSCEND-2.
During TRANSCEND-1, patients will continue to use their regular prescribed medication as usual except for upto 5 study visits, where patients will be asked to come off their study medication. Patients will stop taking their Parkinson’s medication 12-24 hours prior to the visit. Once they have completed the off assessments patients can then take their medication and continue with the remaining study assessments. For 3 consecutive days prior to each clinic visit, patients will be asked to complete a diary (to assess if Parkinson's disease is affecting them); At each visit the following will be assessed, motor skills (ability to perform specified movements), cognitive function (thinking, reasoning, memory), their mood and their quality of life. At each visit, patients will be asked about their level of interest in participation in TRANSCEND-2.REC name
London - West London & GTAC Research Ethics Committee
REC reference
22/LO/0054
Date of REC Opinion
4 Apr 2022
REC opinion
Further Information Favourable Opinion