Home › Research › Treatments
A six-month double-blind, randomized, placebo-controlled study of a transdermal patch in Alzheimer's disease--rivastigmine patch versus capsule
Winblad B, Cummings J, Andreasen N, Grossberg G, Onofrj M, Sadowsky C, Zechner S, Nagel J et al.. International journal of geriatric psychiatry, 2007-05-01
Topic: Drug trials: efficacy and safety
Objectives 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). Methods In this 24-week, multicenter, double-blind, double-dummy, placebo- and active-controlled trial, patients with probable AD were randomized to one of four treatment groups: 12 mg/day rivastigmine capsules; 10 cm2 (9.5 mg/24 h) rivastigmine patch; 20 cm(2) (17.4 mg/24 h) rivastigmine patch; or placebo. Primary efficacy measures were the Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-Cog) and Alzheimer's Disease Cooperative Study--Clinical Global Impression of Change (ADCS-CGIC). Results One thousand one hundred and ninety five AD patients from 21 countries participated in the study. Treatment differences (vs placebo) on the ADAS-Cog at Week 24 in 10 cm2 patch, 20 cm2 patch and capsule groups were 1.6 (p=0.005), 2.6 (p<0.001) and 1.6 (p=0.003). Treatment differences on the ADCS-CGIC were 0.3 (p=0.01), 0.2 (p=0.054) and 0.3 (p=0.009). Comparison between the 10 cm2 patch and the capsule revealed non-inferiority. Rates of nausea in the 10 cm2 patch and capsule groups were 7.2% and 23.1%, respectively; rates of vomiting were 6.2% and 17.0%, respectively. Moderate or severe skin irritation occurred in<or=10% patients across the four patch sizes (5, 10, 15 and 20 cm2). Conclusions The target dose of 10 cm2 rivastigmine patch provides efficacy similar to the highest doses of capsules with a superior tolerability profile. The transdermal patch with rivastigmine may offer convenience important to many caregivers and patients.
Key findings
- Results One thousand one hundred and ninety five AD patients from 21 countries participated in the study.
- Comparison between the 10 cm2 patch and the capsule revealed non-inferiority.
New to this subject? Start with our plain-English guide: Treatments →
Study details
- Effect size7.2%; 23.1%; 6.2%
- Evidence strengthHigh
How this study scored 74/100
Published in a peer-reviewed journal, and it is a randomised controlled trial. Scored zero for sample size because the record does not state it. We have no data on journal's citation record, times cited, citations per year, impact for its field and year, cited by studies here, still being cited, senior author's track record and institution's track record, so those were left out: it earned 45 of the 61 points we could judge it on, which is 74 out of 100.
| Component | Points | Why |
|---|---|---|
| Journal tier | 7 / 10 | Tier 3 — peer-reviewed journal (International journal of geriatric psychiatry) |
| Journal's citation record | — / 4 | No journal record from OpenAlex — left out of this score |
| Study design | 11 / 12 | A randomised controlled trial (from PubMed type “Randomized Controlled Trial”) |
| Strength of evidence | 5 / 5 | Rated “high” in our summary |
| Peer-review validation | 10 / 10 | Peer-reviewed. Published as an article in a named peer-reviewed journal. |
| How recent | 1 / 5 | 2007 — within 20 year(s) of the newest study here |
| Sample size | 0 / 4 | Participant count not stated — scores zero (not stated in the record — scored 0) |
| Effect reported | 2 / 3 | Effect reported as a number, without an interval or test |
| Studied in people | 3 / 3 | Studied in people (pubmed indexes it as a clinical or observational study) |
| Randomised / blinded | 2 / 2 | Randomised and blinded or placebo-controlled (as stated in the record) |
| Times cited | — / 7 | No citation count (not found in OpenAlex) — left out of this score |
| Citations per year | — / 5 | No citation count or no year — left out of this score |
| Impact for its field and year | — / 6 | No field-weighted citation impact (OpenAlex has none yet) — left out of this score |
| Cited by studies here | — / 6 | Not yet checked against this library's citation graph — left out of this score |
| Still being cited | — / 4 | No yearly citation counts — left out of this score |
| Senior author's track record | — / 4 | Senior author's record not available — left out of this score |
| Institution's track record | — / 3 | No institution listed in OpenAlex — left out of this score |
| Multi-centre collaboration | 2 / 3 | PubMed indexes it as a multicentre study |
| Indexed in PubMed | 2 / 2 | Indexed in PubMed (PMID 17380489) |
| Free to read | 0 / 2 | Behind a paywall — scores zero |
| Points | 45 / 61 | Scored on 12 of 20 parts. We have no data for the rest, so they are left out: 45 of the 61 points we could judge it on is 74 out of 100. |
| Total | 74 / 100 | — |
What each of these 20 components measures, and what this score is not →
Read the original
Free copy unknown: no free-copy check has an answer for this record yet. That does not mean it is paywalled.
Cite this study APA, Vancouver, BibTeX · download .bib or .ris
Built from the record alzhub holds for this paper, not looked up. Volume, issue and page numbers are not held in the record. The record's author list ends in “et al.”, so not every author is named. Check the citation against the original before you use it.
APA 7th
Winblad, B., Cummings, J., Andreasen, N., Grossberg, G., Onofrj, M., Sadowsky, C., et al. (2007). A six-month double-blind, randomized, placebo-controlled study of a transdermal patch in Alzheimer's disease--rivastigmine patch versus capsule. International journal of geriatric psychiatry. https://doi.org/10.1002/gps.1788
Vancouver
Winblad B, Cummings J, Andreasen N, Grossberg G, Onofrj M, Sadowsky C, et al. A six-month double-blind, randomized, placebo-controlled study of a transdermal patch in Alzheimer's disease--rivastigmine patch versus capsule. International journal of geriatric psychiatry. 2007. doi:10.1002/gps.1788. PMID: 17380489.
BibTeX
@article{winblad2007-17380489,
author = {Winblad, B. and Cummings, J. and Andreasen, N. and Grossberg, G. and Onofrj, M. and Sadowsky, C. and Zechner, S. and Nagel, J. and others},
title = {{A six-month double-blind, randomized, placebo-controlled study of a transdermal patch in Alzheimer's disease--rivastigmine patch versus capsule}},
journal = {International journal of geriatric psychiatry},
year = {2007},
doi = {10.1002/gps.1788},
pmid = {17380489},
url = {https://doi.org/10.1002/gps.1788}
}
Related studies in Treatments
Also tagged “cholinesterase”
271 studies in the library carry the topic tag “cholinesterase”; these are this study's neighbours in a fixed, alphabetical-by-hash tour of them, not the closest in content. All 271 tagged studies.