Axovant Sciences Limited, one of most globally renowned pharmaceutical firms, has recently declared that its Phase 3 MINDSET clinical trial of intepirdine, a drug that has been deemed to improve memory, learning, & cognition, on patients suffering from Alzheimer’s and receiving donepezil treatment, has unfortunately failed to meet its clinical trial endpoints. According to the observations chronicled by the ADCS- ADL (Alzheimer's Disease Cooperative Study-Activities of Daily Living scale) and ADAS-Cog (Alzheimer's Disease Assessment Scale-Cognitive Subscale), patients treated with 35 mg of the drug for nearly 24 weeks have not demonstrated any noticeable signs of improvement in either cognition or in daily activities as compared to the patients receiving the placebo drug treatment.
For the record, the MINDSET clinical trial had been carried out by the biopharma firm to assess the efficiency, safety, and tolerability of the intepirdine drug among the patients undergoing the donepezil treatment for Alzheimer’s disease, for 24 weeks. The clinical experiments were performed to compare the therapeutic effects of daily oral dosages of the intepirdine drug on 1,315 patients spread out between the ages of 50 and 85 years, with the effects of the conventional placebo treatment. According to the Mini-Mental State Examination (MMSE), the baseline score ranged from 10 to 26m while the clinical co-primary efficacy end points of study altered from the baseline across ADCS- ADL and ADAS- Cog.
After 24 weeks of the clinical trials on the Alzheimer patients, the baseline change in the cognitive ability of patients displayed lower improvement in patients treated with intepirdine, with 0.36 ADAS Cog points, as compared to those treated with placebo. Common safety measurements derived from clinical trials exhibited that there was no major difference observed in the daily activities of patients treated with placebo and intepirdine drugs. From among the endpoints examined through CIBIC-Plus (Clinician Interview-Based Impression of Change, plus caregiver input), a notable improvement was observed only in the first key secondary clinical endpoint in the Alzheimer patients treated with intepirdine drug.
The outcomes from the clinical experiments proved to be a major cause of disappointment and concern for Axovant. Reliable sources cite that the company is committed to advance its Phase two-b development study of intepirdine, and nelotanserin, an inverse agonist of the serotonin receptor subtype 5-HT2A. It has been reported that the healing effects of both these drugs on the patients suffering from dementia with Lewy bodies will be assessed during the phase 2b clinical trial study.