Title | Efficacy and Safety of ABT-126 in Subjects with Mild-to-Moderate Alzheimer's Disease on Stable Doses of Acetylcholinesterase Inhibitors: A Randomized, Double-Blind, Placebo-Controlled Study. |
Publication Type | Journal Article |
Year of Publication | 2016 |
Authors | Florian, H, Meier, A, Gauthier, S, Lipschitz, S, Lin, Y, Tang, Q, Othman, AA, Robieson, WZ, Gault, LM |
Journal | J Alzheimers Dis |
Volume | 51 |
Issue | 4 |
Pagination | 1237-47 |
Date Published | 2016 |
ISSN | 1875-8908 |
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 |
Abstract | BACKGROUND: ABT-126 is a potent, selective α7 nicotinic acetylcholine receptor agonist with putative procognitive effects as a monotherapy in treating Alzheimer'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'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 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. |
DOI | 10.3233/JAD-150978 |
Alternate Journal | J. Alzheimers Dis. |
PubMed ID | 26967214 |