Biomind Labs has initiated a Phase II clinical trial to evaluate its 5-Metoxi-N,N-dimethyltryptamine (5-MeO-DMT)-based BMND08, a sublingual formulation for the treatment of anxiety and depression in Alzheimer’s disease.

The placebo-controlled, repeated single dose, double-blind, randomised Phase IIa study will enrol 40 patients aged 50-75 years.

The company’s clinical advisor Dr. Martín Bruno will lead the trial, which is being carried out at Dr. Marcial Quiroga Hospital in Argentina.

Bruno added: “Biomind’s trial aims to clarify the clinical profile of anxiety and depression and its association with Alzheimer’s disease in community samples of Amnestic Mild Cognitive Impairment, evaluating whether progression to Alzheimer’s disease can be delayed through routine monitoring and timely management of anxiety and depressive symptoms.

“Amnestic Mild Cognitive Impairment is characterised by memory impairment with preservation of functional independence and is considered a transitional stage between normal aging and Alzheimer’s disease. However, rates of conversion to Alzheimer’s disease are highly variable.

“Neuropsychiatric symptoms, such as anxiety and depression, are frequent in Amnestic Mild Cognitive Impairment. Both symptoms in Amnestic Mild Cognitive Impairment patients predict conversion to Alzheimer’s disease, over and beyond the effects of memory loss, poor sleep, use of psychotropic medications or atrophy within Alzheimer’s disease neuroimaging biomarkers.”

It is claimed that 10-15% of Amnestic Mild Cognitive Impairment convert to Alzheimer’s disease within a span of a year while others remain stable or improve in memory performance.

Presently, over 55 million people have dementia across the world, with this figure expected to almost double every two decades, touching 78 million by 2030, and 139 million in 2050.