Australian biotechnology company Actinogen Medical has finished enrolling subjects in the Phase IIa XanaCIDD clinical trial of Xanamem for treating cognitive impairment associated with major depressive disorder (MDD).
The trial successfully enrolled a total of 167 participants, who will receive either Xanamem 10mg or a placebo in addition to their existing antidepressant therapy.
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The proof-of-concept, placebo-controlled, parallel-group trial will involve a six-week treatment period followed by four weeks of observation.
It aims to assess the cognitive benefits of Xanamem, a novel small molecule, in persistent MDD patients who exhibit measurable cognitive impairment.
For subjects with a history of antidepressant treatment, Xanamem 10mg or placebo will be administered as a standalone treatment.
The computerised Cogstate ‘attention composite’ test battery, which evaluates attention and working memory, is the trial’s primary endpoint.
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By GlobalDataThese cognitive functions are considered crucial for overall cognitive ability and have been shown to be sensitive indicators of Xanamem’s potential benefits in previous trials, including XanaMIA Part A and XanaHES.
A key secondary endpoint of the study is the Montgomery-Asberg Depression Rating Scale (MADRS), a structured interview that measures symptoms of MDD.
Results from the XanaCIDD trial are anticipated in the third quarter of this year.
Actinogen chief medical officer Dr Dana Hilt said: “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 ongoing 36-week Phase IIb 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.”
