Date: 2014-12-19
Type of
information: Halting of the trial
phase: 3
Announcement: halting of the trial
Company: Roche (Switzerland)
Product: gantenerumab
Action
mechanism: monoclonal antibody. Gantenerumab is an investigational fully human anti-A? antibody, identified and optimized by phage display technology in cooperation with MorphoSys, a Munich-based Biotech. It passes the blood-brain-barrier and has a high capacity to specifically bind to cerebal amyloid plaques. While the exact mechanism of antibody-mediated reduction of the amyloid burden is controversial, there is evidence that upon binding of gantenerumab to amyloid plaques brain-resident microglial cells are activated and clear plaques by a process called phagocytosis.
Disease: Alzheimer's disease
Therapeutic
area: Neurodegenerative diseases
Country:
Trial
details:
Latest
news:
- • On December 19, 2014, Roche announced the decision to discontinue SCarlet RoAD (WN25203), a phase III study of gantenerumab in prodromal (pre/dementia) Alzheimer’s disease, based on results of a pre-planned futility analysis and recommendation by the independent Data Monitoring Committee. No new safety signals for gantenerumab were observed in this analysis and the overall safety profile was similar to that seen in the phase I trial (NN19866). The discontinued SCarletRoAD study has enrolled 799 pre-symptomatic patients with so-called prodromal Alzheimer's Disease.
- Data from the SCarlet RoAD study will be shared with the medical community after full review and analysis. Findings from the trial will inform future research programmes, approaches and clinical trial design.Gantenerumab continues to be evaluated in the phase III Marguerite RoAD study (WN28745) in a later stage of Alzheimer’s disease (mild dementia due to Alzheimer’s). The Marguerite RoAD trial is evaluating gantenerumab in approx. 1,000 patients with mild Alzheimer's Disease. The second trial, run by the Dominantly Inherited Alzheimer Network (DIAN), assesses the safety, tolerability and biomarker efficacy of gantenerumab in individuals who have a genetic predisposition for Alzheimer's disease.
Is
general: Yes
