IDEAL: A 6-month, double-blind, placebo-controlled study of the first skin patch for Alzheimer disease

@article{Winblad2007IDEALA6,
  title={IDEAL: A 6-month, double-blind, placebo-controlled study of the first skin patch for Alzheimer disease},
  author={Bengt Winblad and George T. Grossberg and Lutz Fr{\"o}lich and Martin R. Farlow and Stefan Zechner and Jennifer Nagel and Roger M. Lane},
  journal={Neurology},
  year={2007},
  volume={69},
  pages={S14-S22}
}
The rivastigmine patch is the first transdermal treatment for Alzheimer disease (AD). By providing continuous delivery of drug into the bloodstream over 24 hours, transdermal delivery may offer benefits superior to those of oral administration. This study compared the efficacy, safety and tolerability of rivastigmine patches with capsules and placebo. IDEAL (Investigation of transDermal Exelon in ALzheimer’s disease) was a 24-week, double-blind, double-dummy, placebo- and active-controlled… 

Figures and Tables from this paper

Impact of Rivastigmine Patch and Capsules on Activities of Daily Living in Alzheimer’s Disease

Rivastigmine patches and capsules provide significant effects in both total and subscale ADLs in patients with probable AD, with significantly superior performance in Alzheimer’s Disease Cooperative Study—Activities of Daily Living.

Caregiver preference for rivastigmine patches versus capsules for the treatment of Alzheimer disease

The preference substudy of the IDEAL trial demonstrated that caregivers of AD patients preferred patches to capsules for drug delivery, substantiated by greater satisfaction and less interference with daily life.

A 25-week, open-label trial investigating rivastigmine transdermal patches with concomitant memantine in mild-to-moderate Alzheimer’s disease: a post hoc analysis

Use of the rivastigmine transdermal patch in patients on established memantine appears to be well-tolerated, with only modest, non-significant increases in AEs compared with monotherapy, and did not seem to affect cognition or global functioning adversely.

Effectiveness and tolerability of transdermal rivastigmine in the treatment of Alzheimer’s disease in daily practice

Switching from any other oral acetylcholinesterase inhibitor to transdermal rivastigmine may improve cognition, and the percentage of patients taking psychotropic comedication decreased, particularly in first-time treated rivASTigmine patients.

Rivastigmine transdermal system for the treatment of mild to moderate Alzheimer’s disease

The aim of this review was to provide a concise, comprehensive overview of the clinically relevant safety, tolerability and efficacy information available for the rivastigmine transdermal system, which provides a viable treatment option for patients with mild to moderate AD.

Real-world evaluation of compliance and preference in Alzheimer’s disease treatment: an observational study in Taiwan

With the higher caregiver preference and a good patient compliance, the trans-dermal rivastigmine patch is a suitable treatment choice for patients with mild-to-moderate AD, especially for patients intolerant to oral therapies.

The ACTION study: methodology of a trial to evaluate safety and efficacy of a higher dose rivastigmine transdermal patch in severe Alzheimer's disease

A novel trial in the development of rivastigmine, as it uses a design that does not include a placebo arm, is recruiting patients with severe AD, and includes an ADL measure as a co-primary efficacy variable.

Rivastigmine Transdermal Patch

Treatment with the rivastigmine 9.5 mg/ 24 hours patch was generally well tolerated by patients with Alzheimer’s disease and significantly more caregivers of study patients preferred administering the patch formulation of rivASTigmine than the capsule formulation.

Rivastigmine and Concomitant Memantine in Alzheimer's Disease: Safety and Tolerability

The rivastigmine patch demonstrated more favorable tolerability than rivASTigmine capsules, being associated with fewer adverse events (AEs), serious AEs (10% versus 23%) and gastrointestinal symptoms (4% versus 26% for nausea; 4% versus 11% for vomiting).
...

References

SHOWING 1-10 OF 19 REFERENCES

Caregiver preference for rivastigmine patches versus capsules for the treatment of Alzheimer disease

The preference substudy of the IDEAL trial demonstrated that caregivers of AD patients preferred patches to capsules for drug delivery, substantiated by greater satisfaction and less interference with daily life.

Efficacy and safety of rivastigmine in patients with Alzheimer's disease: international randomised controlled trial.

Rivastigmine improves cognition, participation in activities of daily living, and global evaluation ratings in patients with mild to moderately severe Alzheimer's disease and is the first treatment to show compelling evidence of efficacy in a predominantly European population.

Commentary: Another piece of the Alzheimer's jigsaw.

In a 6 month trial rivastigmine was effective in treating the core cognitive and functional symptoms of patients with mild to moderate Alzheimer9s disease and produces clinically relevant and statistically significant improvements in cognitive and global assessments, and in activities of daily living.

A six‐month double‐blind, randomized, placebo‐controlled study of a transdermal patch in Alzheimer's disease–– rivastigmine patch versus capsule

To compare the efficacy, safety and tolerability of a novel rivastigmine transdermal patch with conventional rivastigmine capsules and placebo in patients with Alzheimer's disease (AD).

Pharmacotherapy of Alzheimer's disease: is there a need to redefine treatment success?

Using expanded criteria for treatment success and clinically relevant outcome measures, data from currently available studies show that cholinesterase inhibitors produce clinically meaningful long‐term benefits in multiple domains in patients with Alzheimer's disease.

An Inventory to Assess Activities of Daily Living for Clinical Trials in Alzheimer's Disease

We developed a set of informant-based items describing performance of activities of daily living (ADL) by patients with Alzheimer's disease (AD) to identify which ADL are useful for assessment of

Assessing Outcomes in Alzheimer Disease

  • L. Schneider
  • Psychology
    Alzheimer disease and associated disorders
  • 2001
A number of instruments are available for assessing domains such as cognition, activities of daily living (ADL), behavior, caregiver burden, quality of life and economics, many of which are reviewed in this article.

Validity and reliability of the Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change. The Alzheimer's Disease Cooperative Study.

The ADCS-CGIC ratings at 12 months were significantly associated with change on four severity scales, and change ratings were sensitive to dementia severity.

Clinical Pharmacokinetics and Pharmacodynamics of Cholinesterase Inhibitors

The knowledge base for the pharmacokinetics and pharmacodynamics of cholinesterase inhibitors continues to expand and increased information available to clinicians can optimise the use of these agents in the management of patients with Alzheimer’s disease.