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NCT03197740
A Multinational, Multi-center, Randomized, Double-blind, Active Comparator, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Donepezil Transdermal Patch in Patients With Alzheimer's Disease
Phase 3 trial testing Donepezil patch in Alzheimer Disease in 399 participants. Completed in 20 July 2020.
3 July 2020
Quick facts
| Lead sponsor | Icure Pharmaceutical Inc. |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 399 |
| Start date | 12 October 2017 |
| Primary completion | 3 July 2020 |
| Estimated completion | 20 July 2020 |
| Sites | 1 location across South Korea |
Drugs / interventions tested
- Donepezil patch
- aricept Tab — full drug profile →
Conditions studied
- Alzheimer Disease — all drugs for Alzheimer Disease →
Sponsor
Icure Pharmaceutical Inc. — full company profile →
Who can join
Adults 50 to 85, any sex, with Alzheimer Disease. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The objective of this study is to evaluate the efficacy and safety of donepezil transdermal patch in patients with mild to moderate Alzheimer's disease. The primary objective is to demonstrate the non-inferiority of the test drug, IPI-301 (donepezil transdermal patch), to the comparator, Aricept tablet, after 24 weeks of treatment in patients with mild to moderate Alzheimer's disease in terms of improvement in cognitive function as assessed by the Alzheimer's Disease Assessment Scale - Cognitive (ADAS-cog) and in terms of global assessment as assessed by Clinician's Interview Based Impression of Change plus Caregiver Input (CIBIC-plus).
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Neurocognitive Disorders: Systematic Review of Approved (2008-2024) and Pipeline Phase III Medications.
Totlani J, Bashir MA, Tay L, Ngor A, et al · · 2025 · PMID 41647067
Verify or expand the search:
- PubMed search for NCT03197740
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03197740 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Icure Pharmaceutical Inc.
- Last refreshed: 11 February 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03197740.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing