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Phase II crossover trial of varenicline in mild-to-moderate Alzheimer’s disease

Authors

Kim, Seong Yoon, Choi, Seong Hye, Rollema, Hans, Schwam, Elias M., McRae, Tom, Dubrava, Sarah, Jacobsen, Janice

Journal

Dementia And Geriatric Cognitive Disorders, Volume: 37, No.: 3-4, Pages.: 232-245

Year of Publication

2014

Abstract

Background: Evidence supports a role of α4β2 receptors in Alzheimer’s disease (AD).; Methods: This Korean, multicenter, double-blind, two-period (6 weeks each), crossover study randomized participants to the order in which they received varenicline (1 mg twice daily) and placebo. Assessments included AD Assessment Scale-Cognitive Subscale (ADAS-Cog) 75, Neuropsychiatric Inventory (NPI), adverse events (AEs) and Columbia-Suicide Severity Rating Scale (C-SSRS).; Results: For varenicline versus placebo (n = 66 randomized), there was no significant difference in the week 6 least square (LS) mean ADAS-Cog 75 total score (primary endpoint; 18.07 vs. 18.49; p = 0.3873) and a slight worsening in the week 6 LS mean NPI (3.82 vs. 2.55; p = 0.0468), primarily driven by decreased appetite/eating. Common treatment-related AEs were nausea (23.3; 3.4%), vomiting (15.0%; 0) and decreased appetite (15.0; 6.8%).; Conclusions: Varenicline did not improve cognition, behavior or global change in this population. The most frequent varenicline-associated AEs were gastrointestinal; psychiatric AEs were rare and similar between the groups.;

Bibtex Citation

@article{Kim_2014, doi = {10.1159/000355373}, url = {http://dx.doi.org/10.1159/000355373}, year = 2014, publisher = {S. Karger {AG}}, volume = {37}, number = {3-4}, pages = {232--245}, author = {Seong Yoon Kim and Seong Hye Choi and Hans Rollema and Elias M. Schwam and Tom McRae and Sarah Dubrava and Janice Jacobsen}, title = {Phase {II} Crossover Trial of Varenicline in Mild-to-Moderate Alzheimer{textquotesingle}s Disease}, journal = {Dementia and Geriatric Cognitive Disorders} }

Keywords

administration & dosage, adverse, aged, aged, 80 and over, alzheimer disease, benzazepines, blood, cognition, double-blind method, drug effects, drug therapy, events, female, humans, male, middle aged, nicotinic agonists, pharmacokinetics, placebos, quinoxalines, severity of illness index, treatment outcome, varenicline

Types of Dementia

Alzheimer’s Disease

Types of Study

Randomised Controlled Trial

Type of Outcomes

Behaviour, Cognition, Other

Type of Interventions

Pharmaceutical Interventions

Pharmaceutical Interventions

Other