Efficacy of donepezil in mild cognitive impairment

Salloway, Stephen; Ferris, Steven; Kluger, Alan; Goldman, Robert; Griesing, T.; Kumar, Dinesh; Richardson, Sharon

doi:10.1212/01.wnl.0000134664.80320.92

Cited by 279 publications

(217 citation statements)

References 35 publications

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“…In the following decade, these drugs were tested for AD prevention in randomized controlled trials (RCTs). Trials involved subjects with mild cognitive impairment (MCI) and showed possible positive effects on some but not all primary endpoints for donepezil [27][28][29] and rivastigmine [30]. However, to date, cholinesterase inhibitors are not approved for prevention.…”

Section: Ad-specific Drugsmentioning

confidence: 99%

Prevention Studies in Alzheimer’s Disease: Progress Towards the Development of New Therapeutics

2015

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Alzheimer's disease (AD) is the most common form of dementia and is a major cause of disability and dependency amongst older people. AD drugs approved so far are symptomatic treatments and are not thought to affect the underlying disease process. Trials conducted with agents aiming to slow or stop disease progression in patients with AD have all failed, perhaps because they were tested too late in the disease process. Therefore, there has been a move towards prevention of AD. This paper presents an overview of trials testing pharmacological interventions for sporadic AD prevention. Those tested to date were initially developed for the treatment of AD or for the treatment of other conditions, rather than being specifically developed for AD prevention. Associated issues, such as evidence of 'proof-of-concept,' doses and safety, are discussed. A major shift has taken place in the methodology of AD prevention trials since the results of the first trials were published in the 1990s. New directions that are currently being considered in ongoing or future prevention trials are discussed, in terms of endpoints, target populations, and study design. The use of AD-specific drugs to prevent AD in high-risk individuals is currently limited by a lack of validated predictive and surrogate markers. Population approaches, such as lifestyle changes, are an alternative strategy that could be of public health interest, but may provide only limited benefits for individuals. The best chance of preventing AD may come from a combination of individual and population prevention approaches. Key PointsFollowing the failure of treatment trials in symptomatic Alzheimer's disease (AD), there has been a move towards prevention of AD.To date, no specific pharmacological intervention has been developed for sporadic AD prevention and trial results have been disappointing.A major shift has taken place in the methodology of AD prevention trials and new directions are being considered in terms of endpoints, target populations, and study design.

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Section: Ad-specific Drugsmentioning

confidence: 99%

Prevention Studies in Alzheimer’s Disease: Progress Towards the Development of New Therapeutics

2015

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“…[16] focused more on short-term symptomatic effects. In this 24-week randomized double-blind placebo-controlled trial, cognitive functioning using the ADAS-Cog and various declarative memory tasks were investigated in 269 patients.…”

Section: Pharmacological Treatment Of MCImentioning

confidence: 99%

Pharmacological Treatment of Mild Cognitive Impairment as a Prodromal Syndrome of Alzheimer's Disease

Karakaya

Fußer²,

Schröder³

et al. 2013

Current Neuropharmacology

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Mild cognitive impairment (MCI) is a syndrome which, depending on various neurobiological, psychological and social factors, carries a high risk of developing into dementia. As far as diagnostic uncertainty and the heterogeneous underlying pathophysiological mechanisms are concerned, only limited therapeutic options are currently available. Clinical trials involving a wide range of substances have failed to show efficacy on primary and secondary outcome parameters. Most results reflect not only a lack of effectiveness of drug therapy but also methodological constraints in true prodromal Alzheimer´s disease (AD) based on clinical criteria. Biomarkers may help to identify MCI as a prodromal phase of dementia, so it is important to use them to improve specificity of case selection in future studies. For MCI as a prodromal syndrome of AD, clinical trials with disease modifying drugs that target underlying pathological mechanisms such as amyloid-beta accumulation and neurofibrillary tangle formation may help develop effective treatment options in the future. Alternative pharmacological approaches are currently being evaluated in ongoing phase 1 and phase 2 studies. Nevertheless, a lack of approved pharmacotherapeutic options has led to specific interventions that focus on patient education and life-style related factors receiving increasing attention.

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“…MCI selection criteria and the overall results from the clinical trial have been reported. 8 Final determination of cognitive status was made by a board-certified psychiatrist (P.M.D.) with expertise in geriatric psychiatry.…”

Section: Subjectsmentioning

confidence: 99%

“…Selection and dosing criteria were as specified for the trial. 8 Neuropsychological assessment consisted of the following tests: Clinical Dementia Rating, MiniMental State Examination (MMSE), Alzheimer Disease Assessment Scale-Cognitive Subscale (ADAS-Cog), New York University Paragraph Test Delayed Recall, Verbal Fluency, Boston Naming Test, Digit Symbol, Digit Span Backward, and Number Cancellation. As such, this was a pilot study, and the sample size was determined by the logistics of recruitment as well as by prior positron-emission tomography and fMRI studies of drug effects.…”

Section: Subjectsmentioning

confidence: 99%

Effects of Donepezil on Cortical Activation in Mild Cognitive Impairment: A Pilot Double-Blind Placebo-Controlled Trial Using Functional MR Imaging

Petrella¹,

Prince²,

Krishnan³

et al. 2008

AJNR Am J Neuroradiol

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Efficacy of donepezil in mild cognitive impairment

Abstract: Although significant treatment effects were not seen in the primary efficacy measures, outcomes on secondary measures suggest promising directions for further evaluation of donepezil treatment in patients with MCI.

Cited by 279 publications

References 35 publications

Prevention Studies in Alzheimer’s Disease: Progress Towards the Development of New Therapeutics

Prevention Studies in Alzheimer’s Disease: Progress Towards the Development of New Therapeutics

Pharmacological Treatment of Mild Cognitive Impairment as a Prodromal Syndrome of Alzheimer's Disease

Effects of Donepezil on Cortical Activation in Mild Cognitive Impairment: A Pilot Double-Blind Placebo-Controlled Trial Using Functional MR Imaging

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