Alzamend announces end of phase 2a trial of dementia therapeutic

A clinical biopharmaceutical company has announced completion of the clinical portion of its phase 2a multiple ascending dose study examining safety and tolerability of AL001 for dementia related to Alzheimer’s disease.

According to a press release from Alzamend Neuro, the purpose of the study was to evaluate AL001, a novel oral lithium-salicylate-L-proline engineered ionic cocrystal, under multiple-dose, steady-state conditions and to determine the maximum tolerated dose for those with mild to moderate AD along with severe cognitive impairment, as well as healthy subjects.

The trial involved six active and two placebo patients each, with multiple ascending doses of AL001 administered three times a day for 14 days under fasted conditions up to tolerability and safety limits that included the maximum doses permitted per study protocol.

“We strongly believe that AL001’s patented ionic cocrystal technology could potentially provide clinicians with a major improvement over current lithium-based treatments and may constitute a means of treating over 40 million American suffering from Alzheimer’s, bipolar disorder, MDD and PTSD,” Alzamend CEO Stephan Jackman said in the release.

The company said it plans to report topline data from the trial in June and anticipates further clinical development for the drug.