Elan has enrolled the first patient in its ELND005 Phase II study to treat agitation/aggression in patients with moderate-to-severe Alzheimer's disease (AD).
The AG201 study is designed to assess ELND005 (Scyllo-inositol) over 12 weeks of treatment in AD patients.
The objectives of the Phase II study are to assess the efficacy, safety and tolerability of ELND005, an orally bioavailable small molecule.
400 patients will be enrolled at multiple sites in the US, Canada and potentially other selected regions.
Transition's licensing partner, Elan, is investigating ELND005 for multiple neuropsychiatric indications based on its projected dual mechanism of action, which includes ß-amyloid anti-aggregation and regulation of brain myo-inositol levels.
A previous Phase II AD Study (AD201) reported that ELND005 decreased the emergence and severity of specific neuropsychiatric symptoms, an effect which appeared to correlate with drug exposure for some symptoms.
According to the study data, 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.