title: Effects of galantamine and galantamine combined with nimodipine on cognitive speed and quality of life in mixed dementia: a 24-week, randomized, placebo-controlled exploratory trial (the REMIX study).
abstract: The effects of galantamine (GAL) on quality of life (QoL) and cognitive speed, as well its effects combined with nimodipine (NIM) in Alzheimer disease (AD) with cerebrovascular disease (mixed dementia), have not been explored.
  
  
  METHODS
  Double-blind, placebo-controlled, multicenter Brazilian trial, studying the effects of GAL/NIM vs. GAL/placebo (PLA) in mild to moderate mixed dementia. Patients were randomized to receive GAL/NIM or GAL/PLA for 24 weeks. Primary efficacy measures were changes on a computerized neuropsychological battery (CNTB) and QoL Scale in Alzheimer's Disease (QoL-AD) from baseline to week 24.
  
  
  RESULTS
  Twenty-one patients received at least one drug dose (9 GAL/NIM and 12 GAL/PLA). Groups were matched for age, sex, education, cognitive and QoL scores at baseline. No significant differences were observed between groups on primary or secondary measures. QoL and cognitive performance showed significant improvement (p<0.05) from baseline when all GAL-treated patients were analyzed. Adverse events were predominantly mild to moderate.
  
  
  CONCLUSIONS
  GAL treatment improved QoL in mixed dementia, in addition to its previously known cognitive benefits. The combination GAL/NIM was not advantageous. However, the small sample size precludes any definitive conclusions. Trial registered at ClinicalTrials.gov: NCT00814658.
authors: Departamento de Clínica Médica, Faculdade de Medicina, Universidade Federal de Minas Gerais, Belo Horizonte, MG, Brazil.
authors: Paulo
authors: P
authors: Caramelli
authors: Centro de Doença de Alzheimer e outras Desordens Mentais na Velhice, Instituto de Psiquiatria, Universidade Federal do Rio de Janeiro, Rio de Janeiro, RJ, Brazil.
authors: Jerson
authors: J
authors: Laks
authors: Serviço de Neurologia, Pontifícia Universidade Católica do Rio Grande do Sul, Porto Alegre, RS, Brazil.
authors: André Luis Fernandes
authors: AL
authors: Palmini
authors: Departamento de Neurologia, Faculdade de Medicina, Universidade de São Paulo, Sao Paulo, SP, Brazil.
authors: Ricardo
authors: R
authors: Nitrini
authors: Serviço de Neurologia, Hospital de Clínicas de Porto Alegre, Universidade Federal do Rio Grande do Sul, Porto Alegre, RS, Brazil.
authors: Márcia Lorena Fagundes
authors: ML
authors: Chaves
authors: Laboratório de Neurociências LIM-27, Departamento e Instituto de Psiquiatria, Faculdade de Medicina, Universidade de São Paulo, Sao Paulo, SP, Brazil.
authors: Orestes Vicente
authors: OV
authors: Forlenza
authors: Liga de Neurologia Cognitiva e Comportamental, Universidade Federal de São Carlos, Sao Carlos, SP, Brazil.
authors: Francisco de Assis Carvalho do
authors: Fde A
authors: Vale
authors: Departamento de Clínica Médica, Faculdade de Medicina, Universidade Federal de Minas Gerais, Belo Horizonte, MG, Brazil.
authors: Maira Tonidandel
authors: MT
authors: Barbosa
authors: Programa Terceira Idade, Departamento e Instituto de Psiquiatria, Faculdade de Medicina, Universidade de São Paulo, Sao Paulo, SP, Brazil.
authors: Cássio Machado de Campos
authors: CM
authors: Bottino
authors: Instituto de Ensino e Pesquisa do Envelhecimento, Departamento de Medicina Geriátrica, Hospital Mater Dei, Faculdade de Ciências Médicas de Minas Gerais, Belo Horizonte, MG, Brazil.
authors: João Carlos
authors: JC
authors: Machado
authors: Pontifícia Universidade Católica do Rio de Janeiro, Rio de Janeiro, RJ, Brazil.
authors: Helenice
authors: H
authors: Charchat-Fichman
authors: Janssen-Cilag Farmacêutica Ltda., Sao Paulo, SP, Brazil.
authors: Fabio Lorea
authors: FL
authors: Lawson
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000544:Alzheimer Disease / Q000188:drug therapy; D002561:Cerebrovascular Disorders / Q000188:drug therapy; D002800:Cholinesterase Inhibitors / Q000008:administration & dosage*; D003071:Cognition / Q000187:drug effects* / Q000502:physiology; D003704:Dementia / Q000188:drug therapy*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D005702:Galantamine / Q000008:administration & dosage*; D006801:Humans; D008297:Male; D009483:Neuropsychological Tests; D009553:Nimodipine / Q000008:administration & dosage*; D011788:Quality of Life; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome; D014665:Vasodilator Agents / Q000008:administration & dosage*
chemical_list: D002800:Cholinesterase Inhibitors; D014665:Vasodilator Agents; D005702:Galantamine; D009553:Nimodipine