Actinogen Medical (ASX:ACW) has announced that following yesterday’s final trial patient visit in the UK, it expects top-line results for the XanaCIDD phase 2a clinical trial in patients with cognitive impairment in major depressive disorder (MDD) to be available in the first half of August.
The trial is a randomised, double-blind, proof-of-concept, placebo-controlled parallel group six-week trial in 167 patients with persistent MDD and measurable cognitive impairment at baseline.
In the trial, Actinogen’s Xanamem (10mg) or placebo are added to the participant’s existing anti-depressant therapy or in patients with a previous history of anti-depressant treatment, used as stand-alone treatment.
The primary endpoint is the computerized Cogstate ‘attention composite’ test battery, measuring attention and working memory, which was shown previously to be a sensitive measure of Xanamem benefit in the prior XanaMIA Part A and XanaHES trials.
Actinogen chief medical officer Dr Dana Hilt said, “We are pleased to announce the final patient visit in our XanaCIDD phase 2a clinical trial in patients with cognitive impairment in major depressive disorder. This robust, placebo-controlled trial of 167 people will inform us if Xanamem can improve cognition in these patients and assess any related effects on symptoms of depression itself.
“Any positive effects on cognition in this trial would confirm prior trial findings of cognitive enhancement and support the likelihood of future success in the on-going 36-week phase 2b XanaMIA trial in patients with Alzheimer’s disease.
“We continue to observe the excellent safety profile for Xanamem and believe its low drug-drug interaction potential makes it an ideal candidate for use in multiple diseases and populations. Cognitive impairment is a clinical deficit observed in many neurological and neuropsychiatric disorders. Therefore, Xanamem may have potential to have procognitive and clinical benefit in a wide variety of disorders.”
