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IDEAL: a 6-month, double-blind, placebo-controlled study of the first skin patch for Alzheimer disease
Winblad B, Grossberg G, Frölich L, Farlow M, Zechner S, Nagel J, Lane R.. Neurology, 2007-07-01
Topic: Amyloid, tau and blood-test diagnosis
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 study. Patients with AD were randomized to placebo or one of three active treatment target dose groups: 10-cm(2) rivastigmine patch (delivering 9.5 mg/24 hours); 20-cm(2) rivastigmine patch (17.4 mg/24 hours); or 6-mg BID rivastigmine capsules. Primary efficacy measures were the Alzheimer's Disease Assessment Scale-Cognitive subscale and Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change. Secondary outcome measures assessed a range of domains, including behavior, cognitive performance, attention, executive functions, and activities of daily living. A total of 1,195 AD patients participated. All rivastigmine treatment groups showed significant improvement relative to placebo. The 10-cm(2) patch showed similar efficacy to capsules, with approximately two-thirds fewer reports of nausea (7.2% vs 23.1%) and vomiting (6.2% vs 17.0%), incidences statistically not significantly different from placebo (5.0% and 3.3% for nausea and vomiting, respectively). The 20-cm(2) patch showed earlier improvement and numerically superior cognitive scores vs the 10-cm(2) patch with similar tolerability to capsules. Local skin tolerability was good. The transdermal patch with rivastigmine may offer additional therapeutic benefits and may prove to be the best delivery system for this drug to treat AD.
Cite this study APA, Vancouver, BibTeX · download .bib or .ris
APA 7th
Winblad, B., Grossberg, G., Frölich, L., Farlow, M., Zechner, S., Nagel, J., et al. (2007). IDEAL: a 6-month, double-blind, placebo-controlled study of the first skin patch for Alzheimer disease. Neurology. https://doi.org/10.1212/01.wnl.0000281847.17519.e0
Vancouver
Winblad B, Grossberg G, Frölich L, Farlow M, Zechner S, Nagel J, et al. IDEAL: a 6-month, double-blind, placebo-controlled study of the first skin patch for Alzheimer disease. Neurology. 2007. doi:10.1212/01.wnl.0000281847.17519.e0. PMID: 17646619.
BibTeX
@article{winblad2007-17646619,
author = {Winblad, B. and Grossberg, G. and Frölich, L. and Farlow, M. and Zechner, S. and Nagel, J. and Lane, R.},
title = {{IDEAL: a 6-month, double-blind, placebo-controlled study of the first skin patch for Alzheimer disease}},
journal = {Neurology},
year = {2007},
doi = {10.1212/01.wnl.0000281847.17519.e0},
pmid = {17646619},
url = {https://doi.org/10.1212/01.wnl.0000281847.17519.e0}
}
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Key findings
- All rivastigmine treatment groups showed significant improvement relative to placebo.
- The 10-cm(2) patch showed similar efficacy to capsules, with approximately two-thirds fewer reports of nausea (7.2% vs 23.1%) and vomiting (6.2% vs 17.0%), incidences statistically not significantly different from placebo (5.0% and 3.3% for nausea and vomiting, respectively).
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Study details
- Participants1,195
- Effect size7.2%; 23.1%; 6.2%
- Evidence strengthHigh
How this study scored 82/100
Published in a leading specialty journal, and it is a randomized controlled trial. 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 50 of the 61 points we could judge it on, which is 82 out of 100.
| Component | Points | Why |
|---|---|---|
| Journal tier | 9 / 10 | Tier 2 — leading specialty journal (Neurology) |
| Journal's citation record | — / 4 | No journal record from OpenAlex — left out of this score |
| Study design | 11 / 12 | A randomized 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 | 3 / 4 | 1,195 participants |
| Effect reported | 2 / 3 | Effect reported as a number, without an interval or test |
| Studied in people | 3 / 3 | Studied in people (participant count stated) |
| Randomized / blinded | 2 / 2 | Randomized 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 |
| Multicenter collaboration | 2 / 3 | PubMed indexes it as a multicentre study |
| Indexed in PubMed | 2 / 2 | Indexed in PubMed (PMID 17646619) |
| Free to read | 0 / 2 | Behind a paywall — scores zero |
| Points | 50 / 61 | Scored on 12 of 20 parts. We have no data for the rest, so they are left out: 50 of the 61 points we could judge it on is 82 out of 100. |
| Total | 82 / 100 | — |
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