Anavex selects Alfred Hospital as lead site for Phase IIa Alzheimer’s trial

The Phase IIa trial will include a total of seven experienced Alzheimer’s disease clinical trial sites in Melbourne.

The company has submitted the clinical trial including the initiation of patient recruitment to Alfred Hospital’s Ethics Committee for approval.

Anavex president and chief executive officer Christopher Missling said after a thorough review process including many international sites, the company is happy to be working with The Alfred Hospital, a world-renowned institution with significant experience in conducting Alzheimer’s clinical trials.

"The current Phase IIa trial is designed to be extremely efficient and embraces both adaptive trial features as well as population pharmacokinetics," Missling said.

"This will enable the trial to determine the ANAVEX 2-73 dose and schedule that may provide the best therapeutic response with the least toxicity.

"We expect that positive results from the trial will provide a value inflection point for the Company and validate our drug candidates as a potentially effective treatments for Alzheimer’s disease and other neurological disorders."

Around 32 patients with mild to moderate AD are expected to be enrolled in the trial, which will have repeated doses, maximum tolerated dose finding, pharmacodynamic investigation and bioavailability evaluation in these patients with a six-month open label follow-up period.

Primary and secondary endpoints of the trial are maximum tolerated dose and relationship between dose and efficacy outcomes measured through MMSE, ADSC-ADL, computerized cognitive tests and electroencephalography/event-related potentials (EEG/ERP).