|The following article is part of conference coverage from the 2018 Alzheimer’s Association International Conference in Chicago, Illinois. Neurology Advisor’s staff will be reporting breaking news associated with research conducted by leading experts in neurology. Check back for the latest news from AAIC 2018.|
CHICAGO — Study patients with prodromal and mild Alzheimer disease treated with the investigational oral agent, BI 409306, did not experience clinically meaningful changes from baseline for a range of doses, according to findings from 2 phase 2 studies that were presented at the 2018 Alzheimer’s Association International Conference, July 22-26, 2018 in Chicago, Illinois.
BI 409306 is a novel selective phosphodiesterase-9A inhibitor being examined for its safety, efficacy, and tolerability in patients with prodromal and mild Alzheimer disease. To assess if treatment could improve cognitive function and memory, researchers conducted 2 proof-of-concept, double-blind, parallel-group, randomized controlled phase 2 studies that included a 12-week treatment period (Study 1 and Study 2).
Four doses of BI 409306 (10 mg to 50 mg) were randomly assigned to patients after a single-blind run-in period. The primary endpoint was change from baseline at week 12 in the Neuropsychological Test Battery total score; secondary endpoints included change from baseline at week 12 in the Clinical Dementia Rating – Sum of Boxes (CDR-SB) and the AD Assessment Scale-cognitive subscale (ADS-Cog11) total score.
Pooled data from the total 457 patients demonstrated no indication of a treatment benefit for BI 409306 when compared with placebo; the results were similar for each of the separate studies. In general, BI 409306 was well tolerated with the highest occurrence of adverse events observed in the highest dose group (50 mg). The authors added that safety data from the separate studies were also consistent with those from the pooled data.
Based on the 2 studies, no clinically meaningful changes from baseline were evident for the different treatment doses given to patients with prodromal or mild Alzheimer disease.
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Frölich L, Wunderlich G, Thamer C, et al. Evaluation of the efficacy, safety, and tolerability of orally administered BI 409306, a novel phosphodiesterase 9 inhibitor, in two randomized controlled phase II studies in patients with prodromal and mild Alzheimer’s disease. Presented at: 2018 Alzheimer’s Association International Conference. July 22-26, 2018; Chicago, IL. Oral presentation #O1-12-02.