Background

AQW 051 is an α7 nicotinic acetylcholine receptor (nAChR) agonist for the oral treatment of cognitive deficits in schizophrenia, Alzheimer's, and Parkinson's diseases. Very little is known about this drug.

Findings

Phase 1 for this compound was conducted in Japan but no further development in this country has been reported.

Development of AQW 051 for Alzheimer's disease appears to be inactive. Clinicaltrial.gov lists one phase 2 trial in 54 patients with mild AD, which began in 2007 and was terminated in 2009.

Development of AQW 051 for cognitive symptoms in schizophrenia began in 2009 with a phase 1/2 study comparing a single dose to placebo in 68 adult patients. It continued in 2010 with a phase 2 dose-finding study comparing 2, 15 and 100 mg/d to placebo on cognitive function in 57 patients with chronic, stable schizophrenia. In September 2012, a third, 12-week phase 2 study began; it compares 10 mg/d of study drug to placebo in 134 adults with schizophrenia. This proof-of-principle study is expected to be complete in December 2013.

In addition, this compound has been tested in a phase 2 trial for its ability to reduce L-dopa induced dyskinesia in people with moderate to advanced Parkinson's disease. This 71-patient trial began in 2011 and ended in 2013.

No results of AQW 051 studies have been posted on clinicaltrials.gov or published in the peer-reviewed literature. For all AQW 051 trials, see clinicaltrials.gov. 

A phase II study was initiated in December 2007 to investigate the efficacy of AQW 051 treatment in patients with either mild Alzheimer's disease or amnestic mild cognitive impairment (NCT00582855). However, the trial was discontinued in June 2009. The study was being conducted in the UK and Canada ⁴.

Previously, phase I studies of the product were also conducted in healthy volunteers in Japan (NCT00409500) and the UK (NCT00418002) ^{5 6}.

Drug-induced dyskinesia: Novartis completed a phase II trial of AQW 501 in patients with Parkinson's disease in February 2013 (NCT01474421). The study evaluated the safety, tolerability and efficacy of the agent in treating moderate-to-severe L-dopa induced dyskinesias. A total of 90 patients were enrolled in the US, France, Germany and Italy ⁷.