Donepezil for dementia due to Alzheimer's disease

Birks, J; Harvey, Richard J.

doi:10.1002/14651858.cd001190

Cited by 187 publications

(150 citation statements)

References 66 publications

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“…Patients in the studies were randomly assigned to either placebo or active treatment, and treatment arms were equally balanced with regard to age, gender, etc. The standardized effect size of Cerebrolysin on the cognitive domain in the present analysis (SMD -0.37, OC, month 6) was comparable to the range seen for other antidementia treatments [18,20,39,40,41,42]. The effect size of Cerebrolysin on the global domain (OR 4.98), as assessed by the CIBIC+ instrument (by itself a measure of clinical relevance) or CGI, supported the clinical importance of this cognitive benefit.…”

Section: Discussionsupporting

confidence: 76%

“…This is a common Cochrane methodology for handling of different outcome scales in the same domain, allowing the combination of results based on means, independent of any specific scale, and also allowing comparison with published SMD results of previous meta-analyses performed by other authors (regarding the use of SMDs for meta-analyses of cognitive scales, see the recommendations of the Cochrane Collaboration [18,19] and IQWIG [20]).…”

Section: Methodsmentioning

confidence: 99%

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Cerebrolysin in Mild-to-Moderate Alzheimer's Disease: A Meta-Analysis of Randomized Controlled Clinical Trials

Gauthier

Proaño

Jia

et al. 2015

Dement Geriatr Cogn Disord

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Objective: The aim of this study was to provide a systematic and quantitative summary of benefit and risk of Cerebrolysin in patients with mild-to-moderate Alzheimer's disease (AD) and to avoid major deficiencies of an earlier meta-analysis. Design: This is a meta-analysis of randomized double-blind placebo-controlled clinical trials. Data Sources: Trials were identified with the help of PubMed, the Cochrane Dementia Group database, the Center for Collaborative Neurosciences, and references from reviews; no language restrictions were applied. Study Selection: All randomized double-blind placebo-controlled studies on 30 ml/day of Cerebrolysin in mild-to-moderate AD were included. Results: There were 6 eligible randomized controlled trials comparing Cerebrolysin with placebo. For all studies, either individual patient data and/or published data (aggregate data) were available. Analyses were based on the odds ratio (OR) for dichotomized global clinical change and for safety criteria, on the standardized mean difference (SMD) for pooling of cognitive function, and on the Mann-Whitney statistic (MW) for multivariate analysis of ‘global benefit' (combined effect of global clinical change and cognitive function). Cerebrolysin was significantly more effective than placebo at 4 weeks regarding cognitive function (4 weeks: SMD -0.40 points; 95% CI -0.66 to -0.13; p = 0.0031; 6 months: SMD -0.37 points; 95% CI -0.90 to 0.16; p = 0.1710), at 4 weeks and 6 months regarding global clinical change (4 weeks: OR 3.32; 95% CI 1.20-9.21; p = 0.0212; 6 months: OR 4.98; 95% CI 1.37-18.13; p = 0.0150), and at 4 weeks and 6 months regarding ‘global benefit' (combined efficacy criteria; 4 weeks: MW 0.57, 95% CI 0.53-0.61; p = 0.0006; 6 months: MW 0.57; 95% CI 0.53-0.61; p = 0.0010). The safety aspects of Cerebrolysin were comparable to placebo. Conclusion: This meta-analysis provides evidence that Cerebrolysin has an overall beneficial effect and a favorable benefit-risk ratio in patients with mild-to-moderate AD. Cerebrolysin as a therapeutic agent should be considered by clinicians seeking treatment options for mild-to-moderate AD.

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Section: Discussionsupporting

confidence: 76%

Section: Methodsmentioning

confidence: 99%

Cerebrolysin in Mild-to-Moderate Alzheimer's Disease: A Meta-Analysis of Randomized Controlled Clinical Trials

Gauthier

Proaño

Jia

et al. 2015

Dement Geriatr Cogn Disord

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“…It is less complete and less informed than the various reviews and metaanalyses that preceded it (e.g. Birks et al, 2000;Birks et al, 2003;Loy and Schneider, 2004) and less transparent than the appraisers' review and meta-analysis posted on the NICE website. The group's considerable technical skill, documented on the website by their highly detailed data extraction tables from the selected trials was not matched by a similar degree of understanding or interpretive acumen.…”

mentioning

confidence: 99%

The post‐modern world of Alzheimer's disease trials: how much is an ADAS‐cog point worth in central London?

Schneider

2005

Int J Geriat Psychiatry

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“…This has been mainly on the strength of many randomised placebocontrolled trials showing a statistically significant improvement in cognitive, functional and behavioural scores mainly at 12 and 24 weeks. 1,2,3 The questions now are whether this statistical difference translates into a clinically meaningful difference and whether treatment is cost-effective. The AD2000 trial 4 sheds light on this question.…”

mentioning

confidence: 99%

“…1,2,3 The questions now are whether this statistical difference translates into a clinically meaningful difference and whether treatment is cost-effective. The AD2000 trial 4 sheds light on this question.…”

mentioning

confidence: 99%

What now for Alzheimer's disease? An epidemiological evaluation of the AD2000 trial

Attia¹,

Schofield²

2005

Aust Prescr

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In recent years, acetylcholinesterase inhibitors have been approved for the treatment of Alzheimer's disease. This has been mainly on the strength of many randomised placebocontrolled trials showing a statistically significant improvement in cognitive, functional and behavioural scores mainly at 12 and 24 weeks. 1,2,3 The questions now are whether this statistical difference translates into a clinically meaningful difference and whether treatment is cost-effective. The AD2000 trial 4 sheds light on this question.This placebo-controlled trial of donepezil was not sponsored by a drug company. The trial has many strengths as it:■ is the only trial to look at end points beyond one year ■ focuses primarily on clinical end points such as time to institutionalisation or progression to disability ■ includes measures of caregiver burden (as a secondary outcome)■ enrolled a broader spectrum of patients than those typically included in trials sponsored by drug companies.The drawbacks of the trial were that recruitment was slower and smaller than planned (566 versus 3000 patients). It had a complex design (multiple treatment phases and washout periods) and a large withdrawal rate. This makes a true intention-to-treat analysis difficult, however, the overall effect of these factors is to bias away from the null, that is to overstate the effect size. With this caveat in mind, the results show:■ A difference in the 30-point mini-mental state examination of 0.8 points (95% CI 0.5-1.2*) between the treatment and placebo groups at two years. This is about half the treatment effect previously seen at one year in other trials (1.8 points, 95% CI 0.5-3.2). Amiodarone is a drug with many possible adverse reactions.Terry Campbell therefore advises on how to minimise the risk of serious adverse effects.

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Donepezil for dementia due to Alzheimer's disease

Abstract: Analysis 2.12. Comparison 2 Donepezil (5 mg/day or 10 mg/day) versus placebo, Outcome 12 ADL and IADL (CMCS)

Cited by 187 publications

References 66 publications

Cerebrolysin in Mild-to-Moderate Alzheimer's Disease: A Meta-Analysis of Randomized Controlled Clinical Trials

Cerebrolysin in Mild-to-Moderate Alzheimer's Disease: A Meta-Analysis of Randomized Controlled Clinical Trials

The post‐modern world of Alzheimer's disease trials: how much is an ADAS‐cog point worth in central London?

What now for Alzheimer's disease? An epidemiological evaluation of the AD2000 trial

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