Alzamend Neuro initiates its Phase IIa clinical trial with AL001 for mild to moderate AD


On 5 May, Alzamend Neuro, an early clinical-stage biopharmaceutical company focused on developing novel products for the treatment of neurodegenerative diseases and psychiatric disorders, announced the initiation of its Phase IIa clinical trial with AL001 for the treatment of dementia related to Alzheimer’s disease (AD). The Phase IIa study will evaluate the safety and tolerability of AL001 under multiple-dose, steady-state conditions and determine the maximum tolerated dose in people with mild to moderate AD. AL001 is a novel lithium-delivery system with the potential to deliver benefits of marketed lithium carbonate while mitigating or avoiding current toxicities associated with lithium. The company announced that the first participant with mild to moderate AD has been dosed. Up to 40 participants will complete the Phase IIa trial. Multiple ascending doses will be administered for 14 days under fasted conditions (at least 1 hour before or 4 hours after meals). The maximum tolerated dose will then be used for further studies.