In September 2016, Avraham Pharmaceuticals released the results of its Phase 2 clinical trial for the evaluation of the safety and efficacy of ladostigil, for the treatment of mild cognitive impairment (MCI).
The Phase 2b trial was a 3-year, multi-center, randomized, double-blind, placebo-controlled trial that included 210 MCI patients (assigned 1:1 to ladostigil vs. placebo) in 16 centers in Europe and Israel.
The results reflect data from all patients in the modified ITT population who were randomized and had at least one follow-up evaluation. The primary objective was to determine whether ladostigil can delay or prevent the progression of MCI patients to Alzheimer’s disease, which was assessed using the Clinical Dementia Rating scale (CDR), a standard measurement tool for determining the stage of dementia. Although the primary endpoint did not reach statistical significance, the results point to a positive trend (p=0.19) of the ladostigil treated group in comparison to the placebo treated group in the number of patients who did not progress from MCI to Alzheimer’s disease. Twenty-one patients, out of 103 (20%), of the placebo group converted to AD, compared to only 14 patients out of 99 (14%).
The results show statistically significant protection of ladostigil against loss of whole brain volume as measured by MRI (p=0.02). Brain volume measurements are known biomarkers for neurodegenerative disease. Longitudinal MRI studies improve predictive power in assessing the prognosis of individuals with MCI. Furthermore, the data shows a positive trend in the RAVLT total delayed scale that represents a cognitive scale measuring episodic memory.
An independent data and safety monitoring board (DSMB) evaluated the safety data on all patients participating in the trial. The DSMB concluded that there were no serious or unexpected adverse events related to the drug. The DSMB members also reviewed the efficacy data and recommended to continue with its clinical development.
The results will be presented by Professor Lon S. Schneider, MD Professor of Psychiatry, Neurology, and Gerontology,Keck School of Medicine of USC, Los Angeles, CA, USA at the upcoming CTAD conference in San Diego. The company is currently in discussions with big Pharma companies for finding a strategic partner to further develop this drug.