Galantamine treatment in Alzheimer's disease: response and long-term outcome in a routine clinical setting (original) (raw)
Medical Journal of Indonesia, 2007
Penelitian ini bertujuan menilai efektivitas dan keamanan Acetylcholinesterase Inhibitor Galantamine pada penderita Alzheimer dan Alzheimer's Disease (AD) yang disertai dengan penyakit serebrovaskular (AD+CVD atau Mixed Dementia). Galantamine diberikan selama 6 bulan pada 28 penderita AD dan AD + CVD. Evaluasi kognitif dilakukan dengan menggunakan Mini Mental State Examination (MMSE), Restricted Reminding (RR), Neuropsycholgy Assessment, evaluasi fungsi global dengan Clinical Dementia Rating (CDR), evaluasi perubahan perilaku dengan Neuropsychiatric Inventory (NPI). Hasil penelitian pada 28 penderita AD dan AD + CVD, Galantamine memberikan perbaikan fungsi kognitif yang bermakna secara klinis maupun statistik setelah terapi 6 bulan dibandingkan data dasar awal (skor MMSE p<0.05, skor RR p<0.05, NA p<0.05), perbaikan fungsi global (CDR p<0.05) dan perbaikan gejala perilaku (NPI p<0.05). Efek samping ringan (32%) mual-mual dan anokresia terjadi saat titrasi dosis obat dan dapat diatasi dengan domperidone. Disimpulkan bahwa Galantamine efektif memberikan perbaikan fungsi kognitif, fungsi global, gejala perilaku dan aman serta dapat ditoleransi dengan baik.
Dose and plasma concentration of galantamine in Alzheimer's disease - clinical application
Alzheimer's Research & Therapy, 2013
Introduction: Patients with Alzheimer's disease (AD) are currently treated with cholinesterase inhibitors, such as galantamine, without actual knowledge of its concentration in plasma. Our objective was to analyse potential relationships between galantamine concentration, galantamine dose, socio-demographic characteristics, body weight, body mass index (BMI), and treatment response.
International Journal of Clinical Practice, 2006
The objective is to evaluate the efficacy of galantamine when a slow titration regimen is employed in Thai Alzheimer's disease (AD) patients with or without cerebrovascular disease and vascular dementia (VaD).A 6-month, multicentre, open-label, uncontrolled trial was undertaken in 75 AD patients. Eligible patients received an initial galantamine dose of 8 mg/day and escalated over 5–8 weeks to maintenance doses of 16 or 24 mg/day. Primary efficacy measures were AD Assessment Scale-cognitive subscale (ADAS-cog) and the Clinician's Interview-Based Impression of Change-Plus version (CIBIC-plus). The Behavioural Pathology in AD Rating Scale (BEHAVE AD), the AD Cooperative Study Activities of Daily Living Inventory and Pittsburgh Sleep Quality Index were the secondary efficacy variables. Analyses were based on the intent-to-treat population.Treatment with galantamine showed significant improvement in cognition on the ADAS-cog and CIBIC-plus at month 6. Galantamine showed favourable effects on activities of daily living. Behavioural symptoms and sleep quality were also significantly improved (p < 0.05). Galantamine was well tolerated. The adverse events were mild-to-moderate intensity. The most frequent adverse events commonly reported were nausea (16.4%), dizziness (9.6%) and vomiting (6.8%).The results of this study may be consistent with galantamine being an effective and safe treatment for mild-to-moderate AD patients with or without cerebrovascular disease and VaD. Flexible dose escalation of galantamine was well tolerated. The daily maintenance dose of galantamine was 16 mg/day, followed by a back up dose of 24 mg/day.
The Lancet Neurology, 2009
Background The effi cacy of galantamine has been shown in patients with mild, moderate, and advanced moderate Alzheimer's disease (AD). Here we report its effi cacy in patients with severe AD. Methods Between December, 2003, and March, 2007, patients aged 84 (SD 6) years with severe AD (mini-mental state examination [MMSE] score 5-12 points), in a nursing home setting were randomly assigned to receive galantamine (n=207), titrated initially to 24 mg/day, or placebo (n=200). Co-primary effi cacy measures for cognitive function and ability to undertake normal daily activities were the severe impairment battery (SIB) and the seven-item minimum data set-activities of daily living (MDS-ADL), respectively. Adverse events, vital signs, laboratory parameters, and electrocardiograms were monitored. This trial is registered with ClinicalTrials.gov, number NCT00216593. Findings 168 of 207 (81%) patients in the galantamine group and 161 of 200 (81%) in the placebo group completed the study. Mean SIB scores increased (improved) by 1•9 (95% CI-0•1 to 3•9) points with galantamine and decreased (worsened) by 3•0 (-5•6 to-0•5) points with placebo (between-group least squares mean diff erence 4•36, 1•3 to 7•5; p=0•006). Mean MDS-ADL self-performance score worsened by 1•2 (0•6 to 1•8) points and 1•6 (0•8 to 2•3) points, respectively (between-group least squares mean diff erence-0•41,-1•3 to 0•5; p=0•383). Nominally signifi cant between-group diff erences in favour of galantamine occurred for the SIB domains of memory (p=0•006), praxis (p=0•010), and visuospatial ability (p=0.002), and for the MDS-ADL subitem locomotion on unit (p=0•021). 183 of 207 patients (88%) who received galantamine and 177 of 200 (89%) who received placebo had adverse events, which were mostly mild to moderate. Eight patients (4%) in the galantamine group and 21 patients (11%) in the placebo group died. ECG abnormalities were similar between the two groups. Interpretation Galantamine can be started and used safely in elderly patients with severe AD. Galantamine improved cognitive function but failed to signifi cantly improve the co-primary parameter of overall activities of daily living. Funding Janssen-Cilag EMEA.
Neuropsychiatric disease and treatment, 2017
Long-term maintenance of cognitive function is an important goal of treatment for Alzheimer's disease (AD), but evidence about the long-term efficacy of cholinesterase inhibitors is sparse. To evaluate the long-term efficacy and safety of galantamine for AD in routine clinical practice, we conducted a 72-week post-marketing surveillance study. The effect of galantamine on cognitive function was estimated in comparison with a simulated disease trajectory. Patients with mild-to-moderate AD received flexible dosing of galantamine (16-24 mg/day) during this study. Cognitive function was assessed by the mini mental state examination (MMSE) and the clinical status was determined by the Clinical Global Impression-Improvement (CGI-I). Changes of the MMSE score without treatment were estimated in each patient using Mendiondo's model. Generalized linear mixed model analysis was performed to compare the simulated MMSE scores with the actual scores. Of the 661 patients who were enrolled...
Journal of Alzheimer's disease : JAD, 2011
Galantamine improved symptoms in Alzheimer's disease (AD) patients after 5 to 6 months of treatment. To examine long-term outcomes, this study assessed if continuing of galantamine treatment beyond 12 months delayed further cognitive deterioration. It consisted of two phases: an open label (OL) phase (12 months), followed by a double blind, randomized, placebo controlled withdrawal phase (up to 24 months). Subjects with mild to moderate AD were included in the study and titrated up to 16 mg/day of galantamine. Subjects were eligible to enter the double blind phase if a cognitive decline of <4 points on AD Assessment Scale-cognitive subscale (ADAS-cog)/11 was recorded at the end of the OL phase. The differences between galantamine and placebo in time to dropout were estimated using the Cox proportional hazard model. 47.4% of galantamine and 31.7% of placebo subjects completed the double blind phase. Placebo subjects were more likely to discontinue prematurely than galantamine ...
Galantamine plasma concentration and cognitive response in Alzheimer’s disease
PeerJ, 2019
Background Galantamine has been approved for the treatment of Alzheimer’s disease (AD). However, there are few studies which have reported the association between cognitive responses and galantamine plasma concentration. The aim of this study was to determine the correlation between galantamine plasma concentration and the subsequent cognitive response following treatment in AD patients. Methods AD sufferers who continuously took 8 mg/d galantamine for at least 6 months without previous exposure to other kinds of AChEI such as donepezil, rivastigmine, or memantine were included in this cohort study. The assessments included the Mini Mental Status Examination (MMSE), Clinical Dementia Rating Scale (CDR) and the Cognitive Assessment Screening Instrument (CASI). Each subdomain of the CASI assessment was conducted at baseline and after 6 months of galantamine. The plasma concentrations of galantamine were measured by capillary electrophoresis after 6 months of the treatment. Logistic re...
Journal of the Medical Association of Thailand = Chotmaihet thangphaet, 2009
The purpose of this study was to explore factors that influence the clinical safety and tolerability associated with galantamine administration in Thai Alzheimer's disease patients with or without cerebrovascular disease and vascular dementia. This was an analysis of previous study. Tolerability and safety profile were analyzed according to sex, age, body weight, Thai mental state examination (TMSE) score, Alzheimer's disease assessment scale-cognitive subscale (ADAS-cog) score, and Alzheimer's disease cooperative study/activities of daily living (ADCS/ADL) score. The most common adverse events were nausea, dizziness, and weight loss which more often occurred during the dose-escalation phase. Mean body weight lost at week 24 was 0.9 kg. Sex, age, body weight, and ADAS-cog score did not influence the incidence of any adverse events. Dizziness was more likely to occur in patients with low TMSE and high ADCS/ADL score (p = 0.02 and p = 0.050, respectively). Patients with TM...
2016
ABSTRACT- Objective: To investigate the effects of galantamine on the performance of patients with mild to moderate Alzheimer’s disease (AD) in a computerized neuropsychological test battery (CNTB). Method:Thirty-three patients with probable AD were treat-ed with galantamine for three months and evaluated in a prospective, open-label, multi-center study. The CNTB and the ADAS-Cog were administered at baseline and after 12 weeks. The CNTB includes reaction time tests to evaluate attention, implicit and episod-ic memory for faces and words. Statistical comparisons were performed between the results in week 12 versus baseline. Patients who did not reach the therapeutic doses were excluded from the efficacy analysis. Results: Four patients (12.1%) were excluded from the analysis either because of treatment discontinuation (n=3) or because a therapeutic dose was not reached (n=1).The remain-ing 29 patients were treated with doses of 24 mg/day (n=22) and 16 mg/day (n=7). After 12 weeks, s...