Kim, Seong Yoon; Choi, Seong Hye; Rollema, Hans; Schwam, Elias M; McRae, Tom; Dubrava, Sarah; Jacobsen, Janice
Dementia and geriatric cognitive disorders
2014NA ; 37 ( 3-4 ) :232-45.
PMID : 24247022
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Kim, Seong Yoon -
Choi, Seong Hye -
Rollema, Hans -
Schwam, Elias M -
McRae, Tom -
Dubrava, Sarah -
Jacobsen, Janice -
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.
Alzheimer¡¯s disease ¡¤ Cognition ¡¤ Crossover study ¡¤ Partial agonist ¡¤ Receptor activation ¡¤ Varenicline
MESH
Aged, Aged, 80 and over, Alzheimer Disease/*drug therapy, Benzazepines/*administration & dosage/blood/pharmacokinetics, Cognition/*drug effects, Cross-Over Studies, Double-Blind Method, Female, Humans, Male, Middle Aged, Nicotinic Agonists/*administration & dosage/blood/pharmacokinetics, Placebos, Quinoxalines/*administration & dosage/blood/pharmacokinetics, Severity of Illness Index, Treatment Outcome, Varenicline
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