@article {126273, title = {Efficacy and Safety of ABT-126 in Subjects with Mild-to-Moderate Alzheimer{\textquoteright}s Disease on Stable Doses of Acetylcholinesterase Inhibitors: A Randomized, Double-Blind, Placebo-Controlled Study.}, journal = {Journal of Alzheimer{\textquoteright}s disease : JAD}, volume = {51}, year = {2016}, month = {2016}, pages = {1237-47}, abstract = {

BACKGROUND: ABT-126 is a potent, selective α7 nicotinic acetylcholine receptor agonist with putative procognitive effects as a monotherapy in treating Alzheimer{\textquoteright}s disease (AD).

OBJECTIVE: This randomized, double-blind, placebo-controlled multicenter study (NCT01549834) investigated the efficacy and safety of ABT-126 in subjects with mild-to-moderate AD who were taking stable doses of acetylcholinesterase inhibitors (AChEIs).

METHODS: Subjects received 25 mg ABT-126 (n = 143), 75 mg ABT-126 (n = 145), or placebo (n = 146) once daily for 24 weeks. Subjects who completed the 24-week double-blind study were eligible to enroll in a 28-week open-label extension study (NCT01690195) and received 75 mg ABT-126 daily. The primary efficacy endpoint was the change from baseline to week 24 in the 11-item total score of the Alzheimer{\textquoteright}s Disease Assessment Scale- Cognitive Subscale (ADAS-Cog).

RESULTS: Neither dose of ABT-126 demonstrated significant improvement compared with placebo in the primary efficacy endpoint. However, 25 mg ABT-126 demonstrated significant improvement compared with placebo in ADAS-Cog scores at week 4 (least squares mean difference, -1.21; standard error, 0.51; p \<  0.010, one-sided); 75 mg ABT-126 did not demonstrate significant improvements in ADAS-Cog scores compared with placebo at any time point. A treatment effect was not observed for any secondary efficacy measures of cognition, function, or global improvement. ABT-126 was generally well tolerated; the most common adverse events were agitation, constipation, diarrhea, fall, and headache.

CONCLUSIONS: Overall, the efficacy profile of ABT-126 did not warrant further development as add-on therapy to AChEIs to treat mild-to-moderate AD.

}, keywords = {Activities of Daily Living, Aged, Aged, 80 and over, Alzheimer Disease, Cholinesterase Inhibitors, Disease Progression, Dose-Response Relationship, Drug, Double-Blind Method, Female, Humans, Indans, International Cooperation, Male, Medication Adherence, Middle Aged, Piperidines, Psychiatric Status Rating Scales, Treatment Outcome}, issn = {1875-8908}, doi = {10.3233/JAD-150978}, url = {http://content.iospress.com/articles/journal-of-alzheimers-disease/jad150978}, author = {Florian, Hana and Meier, Andreas and Gauthier, Serge and Lipschitz, Stanley and Lin, Yunzhi and Tang, Qi and Ahmed A. Othman and Robieson, Weining Z and Gault, Laura M} }