Biotechnology company Biogen today announced the decision to discontinue Phase 3 trials ENGAGE and EMERGE, which were designed to evaluate the efficacy and safety of aducanumab in patients with mild cognitive impairment due to Alzheimer’s disease and mild Alzheimer’s disease dementia.
At the Penn Memory Center, seventeen people were participating in the Biogen study. These participants and their study partners have been contacted regarding next steps.
The decision to stop the trials is based on results of a futility analysis conducted by an independent data monitoring committee, which indicated the trials were unlikely to meet their primary endpoint upon completion. The recommendation to stop the studies was not based on safety concerns.
“This disappointing news confirms the complexity of treating Alzheimer’s disease and the need to further advance knowledge in neuroscience,”said Michel Vounatsos, Chief Executive Officer at Biogen. “We are incredibly grateful to all the Alzheimer’s disease patients, their families and the investigators who participated in the trials and contributed greatly to this research.”
Penn Memory Center Co-Director David Wolk, MD, said the result is disappointing, but adds “there are numerous medicines in various levels of development in the pipeline.”
“These drugs represent a variety of new approaches based on our dramatically expanding understanding of the mechanisms of Alzheimer’s Disease. As such, we remain hopeful for progress in the near future,” Dr. Wolk said.
The primary objective of the Biogen study was to evaluate the efficacy of monthly doses of aducanumab as compared with placebo in slowing cognitive and functional impairment as measured by changes in the Clinical Dementia Rating-Sum of Boxes (CDR-SB) score. Secondary objectives were to assess the effect of monthly doses of aducanumab as compared to placebo on clinical progression as measured by Mini-Mental State Examination (MMSE), AD Assessment Scale-Cognitive Subscale (ADAS-Cog 13), and AD Cooperative Study-Activities of Daily Living Inventory (ADCS-ADL-MCI).