Elan Corporation, plc (NYSE: ELN) today announced that it has enrolled the first patient in a Phase 2 clinical trial of ELND005 (Study AG201) for the treatment of agitation/aggression in patients with moderate to severe Alzheimer’s disease (AD).
“Agitation/Aggression are common and distressing neuropsychiatric symptoms (NPS) of AD. These symptoms are a leading cause of patients being placed in nursing homes,” said Dr. Bruno Vellas, MD PhD, Chairman of Internal and Geriatric Medicine at University Hospital Toulouse, France and Principal Investigator of the European Alzheimer’s Disease Consortium. “Approximately 90% of AD patients develop NPS, and up to 60% develop agitation/aggression over the course of their disease. With no approved therapies for agitation/aggression in most countries, including the US, it is a major treatment problem in AD. This trial is an important step in providing a potential therapy to help manage these symptoms.”
“We believe ELND005 has opportunities in symptomatic neuropsychiatric indications based on its potential beneficial effects coupled with a good understanding of its safety profile from earlier clinical trials in AD.” said Dr. Menghis Bairu, Chief Medical Officer and Head of Development at Elan. “Symptomatic treatments are important in AD patient care, especially at the advanced stages of disease. As patients advance in their AD, there is an increase in both the prevalence and severity of agitation/aggression.”
Dr. Bairu added “From a development perspective, given the significant unmet need in this patient group, we believe that potential beneficial effects on agitation/aggression will provide a meaningful advance in patient management.”About The Study The objectives of Study AG201 are to evaluate the efficacy, safety and tolerability of ELND005 over 12 weeks of treatment in patients with moderate to severe AD, who are experiencing at least moderate levels of agitation/aggression. The study is expected to enroll approximately 400 patients at multiple sites in the US, Canada and other selected regions. In the Phase 2 AD Study (AD201), ELND005 appeared to decrease the emergence and severity of specific NPS, an effect which seemed to correlate with drug exposure for some symptoms. ELND005 also led to a sustained reduction of brain Myo-inositol levels that are thought to play a role in phospho-inositol signaling pathways and synaptic activity. More information on Study ELND005-AG201 will be available at http://www.clinicaltrials.gov/. About Neuropsychiatric Symptoms and Alzheimer’s Disease It is currently estimated that approximately 5.4 million Americans and approximately 7.2 million Europeans have AD and these numbers are expected to rise to 16 million by 2050. AD is a progressive brain disorder that gradually destroys a person’s memory and ability to learn, reason, make judgements, communicate and carry out daily activities. Approximately 90% of AD patients develop NPS, and up to 60% develop agitation/aggression over the course of their disease. Agitation/aggression are among the most disruptive NPS in AD and are associated with increased morbidity and caregiver burden.