Alzamend Neuro Launches Phase II Crossover Trial of AL001 vs Lithium Carbonate
Alzamend Neuro launched a Phase II crossover trial of AL001 at Massachusetts General Hospital in bipolar disorder type I, enrolling six-patient cohorts with 14-day TID dosing, MRI/MRS imaging and a 14-day washout to compare PK against lithium carbonate. Topline data expected Q3 2026 following healthy volunteer imaging results end-March 2026.
1. Phase II Trial Initiation
Alzamend Neuro has initiated a Phase II clinical trial of AL001 in patients with bipolar disorder type I at Massachusetts General Hospital, marking a key transition from healthy volunteer studies to patient-focused evaluation.
2. Crossover Study Design
The trial features a randomized AB/BA crossover design with multiple six-patient cohorts receiving AL001 and lithium carbonate each for 14 days with three-times-daily dosing, separated by a 14-day washout period.
3. Advanced Neuroimaging Measures
During days 14 and 15 of each treatment period, participants will undergo 24-hour pharmacokinetic blood sampling alongside high-resolution MRI and MRS using a specialized head coil to quantify lithium concentrations in blood and specific brain structures.
4. Timeline and Anticipated Data
Topline results from this bipolar disorder study are slated for Q3 2026, following the completion of a healthy subject imaging study with data expected by end-March 2026.