The studies follow a previous investigation, results of which suggested CX717 could provide a new approach to enhancing memory cognition and wakefulness by cortical arousal without systemic stimulating effects. A further phase IIa study, in simulated nightshift work, is also scheduled to start enrollment at the end of August.
The ADHD study is set to enroll 60 adult patients in a randomized double-blind design, which will evaluate two doses of CX717 and placebo. The primary outcome measures will be the change from baseline on the ADHD Rating Scale.
The second study involves the evaluation of two single doses of CX717 in a randomized, double-blind study of twelve subjects with mild to moderate Alzheimer’s disease (AD) and matched controls.
The investigators hope to show CX717 can positively alter regional cerebral blood flow in patients with AD during the performance of an activating task. This result would then allow them to undertake a larger phase II study in AD once confidence in the drug has grown.