WN29722-Gantenerumab in patients with prodromal to mild AD once a week
Research type
Research Study
Full title
A PHASE II, MULTICENTER, OPEN-LABEL, SINGLE ARM STUDY TO EVALUATE THE PHARMACODYNAMIC EFFECTS OF ONCE WEEKLY ADMINISTRATION OF GANTENERUMAB IN PARTICIPANTS WITH EARLY (PRODROMAL TO MILD) ALZHEIMER’S DISEASE
IRAS ID
287569
Contact name
Richard Perry
Contact email
Sponsor organisation
F Hoffmann-La Roche Ltd
Eudract number
2020-001384-87
Duration of Study in the UK
3 years, 7 months, 21 days
Research summary
Study WN29722 is a Phase II, multicenter, open-label study in participants with early
(prodromal to mild) Alzheimer's Disease to evaluate the Pharmacodynamic effect of a once weekly dosing regimen on deposited amyloid, as measured by brain amyloid PET imaging at Weeks 52 and 104.Amyloid is a protein that accumulates in abnormal amounts in the brain forming sticky clumps known as plaques, particularly in people with suspected Alzheimer’s disease. A PET scan with an amyloid tracer allows the doctor to see how much amyloid patients' have in their brain. PET scans will be used to see whether gantenerumab removes amyloid and how this may be associated with patients'response to study drug.
Approximately 20 participants will take part in the study in the UK and 150 worldwide.
The patients that will be included will be 50-90 years old and will have prodromal to mild Alzheimer's disease and will have to have a study partner (a non-professional caregiver) who will also have to agree to the study.
Patients will receive medication according to following schedule either at the site or at home: first 3 doses: 1 inj every 4 weeks, the next 3 doses: 1 inj every 4 weeks, next 6 doses: 1 inj every 2 weeks and for the rest of the the study: 1 inj every week.
All participants will undergo tests to monitor safety (including standard safety blood tests, ECG, MRI scans), cognition, function, and quality of life assessment.
The study the study will last about 2 and a half years and there are 18 visits required this time.The study is sponsored by F. Hoffman La Roche
LAY SUMMARY OF STUDY RESULTS:
"The lay summary of study results will be posted on the forpatients website by the end of March 2024.
https://forpatients.roche.com/en/trials/neurodegenerative-disorder/ad/a-study-to-evaluate-the-pharmacodynamic--pd--effects-of-20860.html"
REC name
East of England - Essex Research Ethics Committee
REC reference
20/EE/0204
Date of REC Opinion
19 Oct 2020
REC opinion
Further Information Favourable Opinion