Alzheimer’s Drug Halts Clinical Progression in Mid-Stage Trial
First treatment to meet FDA’s disease-modification criteria
Breakthrough results have been reported from a phase II study in patients with Alzheimer’s disease (AD).
According to a press release issued by the Austrian company AFFiRiS AG, its proprietary compound AD04 is the first drug to demonstrate clinical and biomarker effects consistent with disease modification in AD patients.
Upon treatment with AD04, effects consistent with disease modification were achieved for at least 18 months in 47% of treated patients. These effects were dose-dependent and were more robust in patients with early disease. Further, the prevention of hippocampal decline was correlated with the treatment’s beneficial effect on clinical progression and was statistically significant (P = 0.0016).
Thus, for the first time, clinical results have met all of the criteria for disease modification issued by both the FDA and the European Medicines Agency, AFFiRiS says.
In the study, a statistically significant correlation was observed between cognitive/functional outcomes and the volume of the hippocampus (the region of the brain in which cognitive and memory functions are located) over 18 months of observation. Similar stabilization was also seen across behavioral and quality-of-life outcomes.
The investigators also reported stabilization of the cognitive/functional endpoint in patients who were treated with AD02, another AD compound developed by AFFiRiS. Cognitive/functional stabilization or improvement was demonstrated by 24% to 31% of treated patients in this trial. However, a statistically significant correlation with the biomarker of hippocampus volume could not be demonstrated during the 18-month observation period. A total of 332 patients were treated, and more than 85% completed the study.
Source: AFFiRiS; June 4, 2014.