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Table 2 EWG project summary

From: Collaborative research between academia and industry using a large clinical trial database: a case study in Alzheimer's disease

Project title

RCTs included (n)

Selection criteria

n

Citation

   

Total

Donepezil

Placebo

 

Rates of cognitive change in AD: observations across a decade of placebo-controlled clinical trials with donepezil

13

Baseline MMSE scores between 10 and 26

Received placebo

3403

NA

3403

[2]

Effectiveness of donepezil in reducing clinical worsening in patients with mild to moderate AD

3

Baseline MMSE scores between 10 and 26

Duration of at least 24 weeks

Available patient-level data for cognitive, global and functional assessments

906

518

388

[3]

Predicting cognitive decline in AD: an integrated analysis

14

Baseline and end-of-study (12- or 24-week) data on cognition, (MMSE and/or ADAS-cog)

3748

2238

1510

[6]

Effect of donepezil on emergence of apathy in mild to moderate AD

2

MMSE scores between 10 and 26

At least 24 weeks' treatment duration

Individual patient-level behavioural data using the NPI available

490

241

249

[7]

Effects of donepezil on activities of daily living: integrated analysis of patient data from studies in mild, moderate and severe AD

6

Available post-baseline functional data collected using at least 1 ADL scale as defined in the original study protocols

2194

1268

926

[4]

Effect of donepezil on cognition in severe AD: a pooled data analysis

4

Available SIB data at both baseline and at study end

904

481

423

[5]

  1. RCTs = randomised, controlled trials, AD = Alzheimer's disease, MMSE = Mini-Mental State Examination, ADAS-cog = Alzheimer's Disease Assessment Scale-cognitive subscale, NPI = Neuropsychiatric Inventory, ADL = activity of daily living, SIB = Severe Impairment Battery.