|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 — Researchers from NeuroActiva, Inc. presented results of their randomized, double-blind, placebo-controlled phase 2A clinical trial of NA-831, demonstrating safety and tolerability and improvements in cognitive outcomes in patients with Alzheimer disease with mild cognitive impairment. The results were the presented at the 2018 Alzheimer’s Association International Conference, held July 22-26, 2018 in Chicago, Illinois.
Patients were included if they were 55 to 80 years of age during initial screening with a score of ≥20 or ≥24 (for those with primary school education or post high school education, respectively) on the Mini-Mental State Exam (MMSE). Participants also had to score <27 on the Center for Epidemiological Studies-Depression (CES-D).
Ultimately, a total of 56 patients were randomly assigned to receive either 10 mg NA-831 daily or matched placebo for 24 weeks. Primary outcomes included change in Alzheimer’s Disease Assessment Scale-Cognitive subscale (ADAS-cog), the Brief Cognitive Rating Scale (BCRS), and the Clinician’s Interview-Based Impression of Change Plus Caregiver Input (CIBIC-plus).
Researchers noted the positive effects of NA-831 on outcomes of the BCRS within 8 weeks, including improvement sin fatigue, anxiety, irritability, affective lability, sleep disturbance, daytime drowsiness, headache, and nocturnal sleep (P =.001). A significant change of 3.21 points in the ADAS-cog score was also noted (NA-831 change −4.47 vs placebo −1.26; P =.001; ITT), as well as an improvement in the CIBIC-plus (23 [82.1%] vs 5 [17.9%]; P =.01; ITT). The drug was well-tolerated at up to 50 mg per day, and no adverse effects were reported.
“NA-831 was effective for improving cognitive and global functioning in patients with mild cognitive impairment,” the researchers concluded. “As an endogenous compound, NA-831 is well-tolerated and has excellent safety profile.”
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Tran B, Tran L. A randomized double-blind placebo-controlled phase 2a clinical trail of na-831 in patients with mild cognitive impairment. Presented at: 2018 Alzheimer’s Association International Conference. July 22-26, 2018; Chicago, IL. Abstract 27358.