Transition Therapeutics Announces Enrollment Of The First Patient In Phase 2 Study Of ELND005 (Scyllo-inositol) For The Treatment Of Agitation/Aggression In Patients With Alzheimer's Disease
- Approximately 90% of AD patients develop neuropsychiatric symptoms
- Approximately 60% of AD patients develop agitation/aggression
TORONTO, Nov. 28, 2012 /PRNewswire/ - Transition Therapeutics Inc. ("Transition" or the "Company") (NASDAQ: TTHI, TSX: TTH) today announced its licensing partner, Elan Corporation, plc ("Elan") has enrolled the first patient in a Phase 2 study of ELND005 (Study AG201) for the treatment of agitation/aggression in patients with moderate to severe Alzheimer's disease (AD).
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 potentially other selected regions. In the Phase 2 AD Study (AD201), ELND005 appeared to decrease the emergence and severity of specific neuropsychiatric symptoms, 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 DiseaseIt 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 neuropsychiatric symptoms, 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.
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