Roche has announced it has ended its phase III clinical trial of the potential Alzheimer’s drug, crenezumab, which was designed to treat people in the early stages of Alzheimer’s disease.
Roche announced the decision to discontinue CREAD I and CREAD 2 (BN29552 and BN29553) Phase III studies of the investigational anti-beta-amyloid molecule crenezumab in people with early (prodromal to mild) sporadic Alzheimer’s disease (AD).
The decision was based on the results of a pre-planned interim analysis assessing the safety and efficacy of crenezumab conducted by the Independent Data Monitoring Committee, which indicated that crenezumab was unlikely to meet the primary endpoint of change from baseline in Clinical Dementia Rating-Sum of Boxes (CDR-SB) Score.
No safety signals for crenezumab were observed in this analysis and the overall safety profile was similar to that seen in previous trials.
Data from the CREAD 1 and 2 studies will be shared with the scientific community at an upcoming medical congress. Findings from the trials will inform future research programmes, approaches and clinical trial designs.
Dr David Reynolds, Chief Scientific Officer from Alzheimer’s Research UK, said: “While it’s disappointing to see any Alzheimer’s trial ended early, the full study results can still provide important insights that could shape future trials to slow or stop Alzheimer’s disease.
“Amyloid remains a key player in Alzheimer’s disease and while a number of ongoing trials are investigating this protein, it’s also important to widen the number of approaches being explored to treat the disease. Alzheimer’s Research UK continues to work with drug discovery experts to strengthen and diversify the pipeline of potential Alzheimer’s treatments in clinical trials to maximise our chances of finding effective new drugs.
“Compared to other health conditions like cancer, research into the diseases that cause dementia have been vastly underfunded. We remain committed to delivering a life-changing dementia treatment and are calling for long-term sustained investment from both pharmaceutical companies, and government to deliver breakthroughs for people with dementia.”