Safety and efficacy of galantamine in subjects with mild cognitive impairment

Winblad, Bengt; Gauthier, Serge; Scinto, Leonard F. M.; Feldman, Howard; Wilcock, Gordon; Truyen, Luc; Mayorga, Arthur J.; Wang, D.; Brashear, H. Robert; Nye, Jeffrey S.

doi:10.1212/01.wnl.0000303815.69777.26

Cited by 236 publications

(180 citation statements)

References 48 publications

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“…In two clinical studies involving 2048 patients with mild cognitive impairment (MCI), galantamine failed to halt the progression of the disease. Total 14 (13 patients receiving galantamine and 1 on placebo) died within 30 d of discontinuing from the double-blind period (per-protocol assessment) however a posthoc analysis of the cohort has showed no increased risk with galantamine [96] . Combination therapy with galantamine (16 mg) with memantine (20 mg) was evaluated in a 2 y, double-blinded, placebo-controlled study with 232 MCI patients.…”

Section: Role Of Traditional Medicinementioning

confidence: 99%

Management of Alzheimers Disease: Role of Existing Therapies, Traditional Medicines and New Treatment Targets

Malve¹

2017

ijps

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Section: Role Of Traditional Medicinementioning

confidence: 99%

Management of Alzheimers Disease: Role of Existing Therapies, Traditional Medicines and New Treatment Targets

Malve¹

2017

ijps

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“…However, to date, cholinesterase inhibitors are not approved for prevention. Trials with galantamine were negative [31,32]. Among more recently developed AD-specific drugs, only one is currently being tested in sporadic AD 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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“…The results of 2 large trials with galantamine (GAL-INT-11, GAL-INT-18) were also disappointing [5]. A sample of 2048 patients with MCI participated and the patients were randomized to two groups, one of which was treated with galantamine (16-24 mg / day) and the other with a placebo.…”

Section: Pharmacological Treatment Of MCImentioning

confidence: 99%

“…[5] the results of GAL-INT-11 and GAL-INT-18 showed a slight but significantly increased mortality risk during treatment with galantamine, suggesting that pharmacological treatment of MCI patients should be undertaken carefully.…”

Section: Pharmacological Treatment Of MCImentioning

confidence: 99%

See 1 more Smart Citation

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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Safety and efficacy of galantamine in subjects with mild cognitive impairment

Cited by 236 publications

References 48 publications

Management of Alzheimers Disease: Role of Existing Therapies, Traditional Medicines and New Treatment Targets

Management of Alzheimers Disease: Role of Existing Therapies, Traditional Medicines and New Treatment Targets

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

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