WN41874 - Gantenerumab Open Label Extension Study
Research type
Research Study
Full title
AN OPEN-LABEL, MULTICENTER, ROLLOVERSTUDY TO EVALUATE THE SAFETY AND TOLERABILITY OF LONG-TERM ADMINISTRATION OF GANTENERUMAB IN PARTICIPANTS WITH ALZHEIMER’S DISEASE
IRAS ID
278137
Contact name
Richard Perry
Contact email
Sponsor organisation
F Hoffmann-La Roche Ltd
Eudract number
2019-004431-23
Duration of Study in the UK
2 years, 3 months, 31 days
Research summary
Summary of Research:
Approximately 50 million people worldwide are living with Dementia. Alzheimer’s Disease (AD) is the most common cause of dementia, accounting for 60-70% of cases. Current approved medical therapies may temporarily improve the symptoms of AD in some patients, but do not modify progression of the disease. The study drug gantenerumab has shown evidence of slowing the progression of AD. Furthermore, data from the open label extension (OLE) studies WN25203 and WN28745 supports the continuation of gantenerumab treatment to slow disease progression. \n\nThe purpose of this phase III study (WN41874) is to evaluate the safety and tolerability of long term treatment of gantenerumab in patients with Alzheimer’s Disease. \n\nThis study will enroll participants who participated in either the WN25203 or WN28745 OLE studies. In this study participants will continue to receive gantenerumab injections at hospital at the same dose received in the OLE study every 4 weeks over 2 years. Participants will attend a follow-up visit at hospital 4 weeks after their last dose of gantenerumab.\n\nDuring the study participants health will be regularly assessed, including brain MRI scans, blood tests, and physical examinations.\n\nAll participants will require a caregiver to support them to attend hospital visits during the 2 year period.\n\nApproximately 168 participants will be enrolled globally and it is anticipated 6 participants will be enrolled from 4 UK sites. \n\nThe study is expected to last for approximately 2 years.\n\nThe study is sponsored by F. Hoffman La Roche\n\nResearch Summary; Version Number 1.0 and date: 29-Jan-2020\n\n
Summary of Results:
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REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
20/YH/0090
Date of REC Opinion
20 Apr 2020
REC opinion
Further Information Favourable Opinion