In 2016, Actinogen Medical initiated XanADu, a Phase II, double-blind, 12-week, randomised, placebo-controlled study to assess the safety, tolerability and efficacy of 10mg daily Xanamem in patients with mild Alzheimer’s disease. Patient recruitment and treatment commenced in mid-2017 and was completed in 2018 with 186 patients randomised across 25 sites in Australia, UK and USA. Results were announced in Q2 CY19. Some of the design features are provided in the table below.
Further information and updates on XanADu, can be found at Clinicaltrials.gov.
COGNITIVE IMPAIRMENT IN MOOD DISORDERS & SCHIZOPHRENIA
Cognitive impairment within mood disorders (unipolar depression, bipolar disorder), as well as schizophrenia, has been studied extensively. Importantly patients with the mood disorders and schizophrenia commonly have associated persistently raised cortisol. In general, unipolar and bipolar patients show impaired performance in cognitive tests of attention, executive function, and memory, and cognitive impairment can be one of the more debilitating consequences of schizophrenia. Increased cognitive dysfunction often is associated with greater symptom severity and patients who present for the first time to a practitioner with complaints of mood disorders are at greater risk of going on to develop Alzheimer’s disease (AD).
Evidence that cognitive decline might develop in conjunction with mood disorders has been confirmed through multiple research studies. A 7-year study followed more than 600 healthy elderly (greater than 64 years old) on measures of mood and cognition. Participants with no depressive symptoms at study intake presented mild, yet progressive, cognitive decline annually, presumably due to the natural effects of aging. With each additional depressive symptom presented at intake, however, the annual rate of cognitive decline increased by 24%. Thus, the number of depressive symptoms at baseline was associated with increased risk of developing AD.
Research has shown a relationship between mood, cognitive decline, and neurological dysfunction. Few studies have, however, examined all three symptom domains within one investigation, and none have used a cortisol inhibitor like Xanamem to test the hypothesis underlying the mechanisms controlling the development and progression of cognitive decline in mood disorders.
Actinogen is currently evaluating the potential to study Xanamem in the treatment of cognitive impairment associated with mood disorders and schizophrenia.