WN42171 POSTGRADUATE Study

• Research type

  Research Study

• Full title

  AN OPEN-LABEL, MULTICENTER, ROLLOVER STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND EFFICACY OF LONG-TERM GANTENERUMAB ADMINISTRATION IN PARTICIPANTS WITH ALZHEIMER'S DISEASE

• IRAS ID

  281982

• Contact name

  Head, EU/ROW Regulatory Affairs Pharmaceutical Division, PDR

• Contact email

  global.eudract@roche.com

• Sponsor organisation

  F Hoffmann-La Roche Ltd

• Eudract number

  2020-000766-42

• Clinicaltrials.gov Identifier

  N/A, N/A

• Duration of Study in the UK

  4 years, 4 months, 30 days

• Research summary

  Alzheimer's Disease (AD) is the most common cause of dementia. It affects an estimated 26.6 million worldwide. Current approved medical therapies may temporarily improve the symptoms of AD in some patients, but do not modify progression of the disease.

  This Phase III, multi-centre, open label rollover study will evaluate the safety, tolerability, and efficacy of long-term administration of open-label gantenerumab in participants with AD who completed parent Studies WN29922 or WN39658 either the double-blind or OLE part as applicable.

  Approximately 2032 participants will be enrolled in this global study. Participants, clinical staff and Sponsor will remain blinded to the previous treatment assignment from the parent studies.

  The dosing and visit schedule will differ for participants according to whether they did or did not complete the OLE part of the parent study: participants who did not take part in the OLE phase (and previously received placebo) will start this study with an uptitration. Following uptitration, participants will receive up to 34 doses of gantenerumab 510 mg every 2 weeks.

  All participants will undergo tests to monitor safety (including standard safety blood tests, ECG, MRI scans), cognition, function, and quality of life assessment.

  There are 2 sub-studies linked to the main study. These are optional to sites and to participants. The participant will need to give express consent to each. The sub-studies will measure by positron emission tomography (PET) scan, deposits of special proteins called “amyloid beta” (in the Amyloid-PET Sub-study) and “tau” (in the tau-PET sub-study) in the brain, to see if treatment with gantenerumab changes the amount these proteins.

  53 patients are expected to roll over at 13 UK sites. The study duration will approximately be 2 years and 3 months.

  The study is sponsored by F. Hoffman La Roche
  Lay summary of study results: https://eur03.safelinks.protection.outlook.com/?url=https%3A%2F%2Fu2790089.ct.sendgrid.net%2Fls%2Fclick%3Fupn%3Du001.QwnS5iG-2B4nwcunWxC03fkI-2B2FmlpOZCx9oHLzlTYNfEUWaADqb0w2tMtRTl1mlmScEYkMZFpzyAGJ43-2BWbPzlNQEP0eEzqWxHI0r5DYgqqg2770l3eyrccHFWWHkMgg0PF3DeL-2Fp5J8TjfMBxznlPHUbtiESB2X4ZW4iCcbkk8iyaH-2BscoJaxplON72U30GLmPaYICTNv-2Fh4Rwa4qTi-2BaQ-3D-3D_Wb6_a04dWCHmDh7gi4hRuvmsd-2FMEDkPNm6D0IRdq0o1v81d-2F-2BMFJ9ds73Z2k7SV2KRzT5yBVEE1pnGvVOdTvSkBwDfuQMpLotwjVm1pkAR4rIenMPSYhePn-2FdSs5tP-2BCeqw2efAD13ohnJPZKm6vEJvg4J2gH9rpxPt40bJKJWGZWluzsPxnybxDh7r-2BLnSKlT4ofqzC3YNBMzz4BrKCnL5pJw-3D-3D&data=05%7C02%7CTracy.Hamrang%40hra.nhs.uk%7Ce68a0fbbdf394c240cea08dc89264106%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638536044616497598%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=0xJX8ZXgRljxR%2BpekvP8kcEmY1YgDrWVDV7HZRbuApE%3D&reserved=0

• REC name

  London - Brighton & Sussex Research Ethics Committee

• REC reference

  20/LO/0821

• Date of REC Opinion

  23 Jul 2020

• REC opinion

  Further Information Favourable Opinion