PMID- 24247022
OWN - NLM
STAT- MEDLINE
DCOM- 20141216
LR  - 20151119
IS  - 1421-9824 (Electronic)
IS  - 1420-8008 (Linking)
VI  - 37
IP  - 3-4
DP  - 2014
TI  - Phase II crossover trial of varenicline in mild-to-moderate Alzheimer's disease.
PG  - 232-45
LID - 10.1159/000355373 [doi]
AB  - BACKGROUND: Evidence supports a role of alpha4beta2 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.
FAU - Kim, Seong Yoon
AU  - Kim SY
AD  - Department of Psychiatry, Asan Medical Center, Seoul, South Korea.
FAU - Choi, Seong Hye
AU  - Choi SH
FAU - Rollema, Hans
AU  - Rollema H
FAU - Schwam, Elias M
AU  - Schwam EM
FAU - McRae, Tom
AU  - McRae T
FAU - Dubrava, Sarah
AU  - Dubrava S
FAU - Jacobsen, Janice
AU  - Jacobsen J
LA  - eng
SI  - ClinicalTrials.gov/NCT00744978
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20131114
PL  - Switzerland
TA  - Dement Geriatr Cogn Disord
JT  - Dementia and geriatric cognitive disorders
JID - 9705200
RN  - 0 (Benzazepines)
RN  - 0 (Nicotinic Agonists)
RN  - 0 (Placebos)
RN  - 0 (Quinoxalines)
RN  - W6HS99O8ZO (Varenicline)
SB  - IM
MH  - Aged
MH  - Aged, 80 and over
MH  - Alzheimer Disease/*drug therapy
MH  - Benzazepines/*administration & dosage/blood/pharmacokinetics
MH  - Cognition/*drug effects
MH  - Cross-Over Studies
MH  - Double-Blind Method
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Nicotinic Agonists/*administration & dosage/blood/pharmacokinetics
MH  - Placebos
MH  - Quinoxalines/*administration & dosage/blood/pharmacokinetics
MH  - Severity of Illness Index
MH  - Treatment Outcome
MH  - Varenicline
EDAT- 2013/11/20 06:00
MHDA- 2014/12/17 06:00
CRDT- 2013/11/20 06:00
PHST- 2013/06/28 00:00 [accepted]
PHST- 2013/11/20 06:00 [entrez]
PHST- 2013/11/20 06:00 [pubmed]
PHST- 2014/12/17 06:00 [medline]
AID - 000355373 [pii]
AID - 10.1159/000355373 [doi]
PST - ppublish
SO  - Dement Geriatr Cogn Disord. 2014;37(3-4):232-45. doi: 10.1159/000355373. Epub 
      2013 Nov 14.