A Randomized Double-blind Study to Assess the Skin Irritation and Sensitization Potential of a Once-weekly Donepezil Transdermal Delivery System in Healthy Volunteers

Topic: Brain proteins, microglia and lab models

Background A once-weekly donepezil transdermal delivery system (TDS; Adlarity; Corium, LLC) is indicated for the treatment of mild, moderate, and severe dementia of the Alzheimer type. Methods In this placebo-controlled, randomized, double-blind phase 1 trial, healthy volunteers aged 40 years or older were randomized to receive a placebo and donepezil TDS and were evaluated for the primary endpoints of skin irritation and sensitization potential. Skin irritation was scored. Results Two hundred fifty-six participants were randomized and received ≥1 dose of any treatment. After the first weekly TDS application, no skin irritation or minimal irritation was evident between donepezil and placebo TDSs. At the third weekly TDS application, for donepezil TDS, the average of the mean combined skin irritation score was 0.55 of a possible maximum of 7, indicating none to minimal skin irritation, and for placebo, the score was 0.19, indicating no skin irritation. Of 198 participants, 4 (2.0%) were considered potentially sensitized to donepezil TDS, and 0 were potentially sensitized to placebo TDS. Conclusion Once-weekly 5-mg/d donepezil TDS demonstrated minimal skin irritation under conditions of use of 3 consecutive weekly patch applications to the same skin site and minimal sensitization potential.

Key findings

• Results Two hundred fifty-six participants were randomized and received ≥1 dose of any treatment.
• Conclusion Once-weekly 5-mg/d donepezil TDS demonstrated minimal skin irritation under conditions of use of 3 consecutive weekly patch applications to the same skin site and minimal sensitization potential.

Why it matters

A once-weekly donepezil skin patch caused little skin irritation and low sensitization in healthy volunteers. This only addresses how well the patch is tolerated, not whether it improves Alzheimer's symptoms.

New to this subject? Start with our plain-English guide: Treatments →

Study details

• Study designclinical trial
• Participants198
• Effect size2.0%
• Evidence strengthHigh

Read the original

• DOI: 10.1097/wad.0000000000000578
• PubMed: 37695107
• Original source →
• Free full text: Alzheimer Disease & Associated Disorders →

Full text: free to read — OpenAlex lists this copy as free to read: the link above (checked 6 Feb 1020).

@article{sabbagh2023-37695107,
  author  = {Sabbagh, M. N. and Mathew, P. and Blau, A.},
  title   = {{A Randomized Double-blind Study to Assess the Skin Irritation and Sensitization Potential of a Once-weekly Donepezil Transdermal Delivery System in Healthy Volunteers}},
  journal = {Alzheimer disease and associated disorders},
  year    = {2023},
  doi     = {10.1097/wad.0000000000000578},
  pmid    = {37695107},
  url     = {https://doi.org/10.1097/wad.0000000000000578}
}

Studies this one cites

Referenced by this study and also in the alzhub library, so you can read them here.

• A 24-week, double-blind, placebo-controlled trial of donepezil in patients with Alzheimer's disease. Donepezil Study Group Neurology · 1998-01-01 · usefulness score 77/100 · Treatments
• Donepezil improves cognition and global function in Alzheimer disease: a 15-week, double-blind, placebo-controlled study. Donepezil Study Group Archives of internal medicine · 1998-05-01 · usefulness score 72/100 · Treatments

Related studies in Treatments

• A Phase I Study to Assess the Effect of Speed of Injection on Pain, Tolerability, and Pharmacokinetics After High-volume Subcutaneous Administration of Gantenerumab in Healthy Volunteers Clinical therapeutics · 2019-12-26 · usefulness score 57/100
• Transdermal Drug Delivery Systems and their Potential in Alzheimer's Disease Management CNS & neurological disorders drug targets · 2020 · usefulness score 39/100
• 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 · 2007-05-01 · usefulness score 74/100
• A 24-week, randomized, double-blind study of donepezil in moderate to severe Alzheimer's disease Neurology · 2001-08-01 · usefulness score 74/100
• The efficacy and safety of donepezil in patients with Alzheimer's disease: results of a US Multicentre, Randomized, Double-Blind, Placebo-Controlled Trial. The Donepezil Study Group Dementia (Basel, Switzerland) · 1996-11-01 · usefulness score 74/100
• Donepezil in Parkinson's disease dementia: a randomized, double-blind efficacy and safety study Movement disorders : official journal of the Movement Disorder Society · 2012-08-22 · usefulness score 70/100

Also in Treatments

166 studies in the library are filed under Treatments with no topic tag they share with another; these are this study's neighbours in a fixed tour of them. The Treatments hub.

• REDEFINING ALZHEIMER’S DISEASE THROUGH MODERN BIOTECHNOLOGY; FROM MOLECULAR PATHOGENESIS TO INNOVATIVE THERAPEUTICS AND DIAGNOSTIC FRONTIERS Journal of medical & health sciences review. · 2025-12-25 · usefulness score 27/100 · Treatments
• FDA Converts Novel Alzheimer's Disease Treatment to Traditional Approval U.S. Food and Drug Administration · 2023-07-06 · usefulness score 14/100 · Treatments
• Perspectives and Insights on Anti-Amyloid Immunotherapy Agents: From Development to Submission of a New Drug Submission (NDS) in Canada Zenodo (CERN European Organization for Nuclear Research) · 2026-07-13 · usefulness score 41/100 · Treatments

Similar studies

• A randomized, double-blind, placebo-controlled study of the efficacy and safety of donepezil in patients with Alzheimer's disease in the nursing home setting 2001 · Treatments
• The efficacy, safety, and tolerability of donepezil for the treatment of young adults with Down syndrome 2009 · Treatments
• Donepezil treatment of patients with MCI: a 48-week randomized, placebo-controlled trial 2009 · Treatments
• A 1-year, placebo-controlled preservation of function survival study of donepezil in AD patients 2001 · Treatments
• Donepezil in the prevention and treatment of post-surgical delirium 2005 · Clinical safety
• Randomized, placebo-controlled trial of the effects of donepezil on neuronal markers and hippocampal volumes in Alzheimer's disease 2003 · Hippocampus size on brain scans

More on Treatments

• A review that covers this ground The GuidAge study: methodological issues. A 5-year double-blind randomized trial of the efficacy of EGb 761 for prevention of Alzheimer disease in patients over 70 with a memory complaint Neurology · 2006-11-01 · usefulness score 65/100
• Newest in this subject Opposing Regulation of Tau Condensation by Phosphorylation Levels and Molecular Chaperone Interactions bioRxiv · 2026-10-30 · Preprint — not yet peer-reviewed · usefulness score 16/100
• Newest in this subject Natural Sesquiterpenoids from Laggera pterodonta as bioactive Acetylcholinesterase Inhibitors: Insights from DFT, Molecular Docking, and ADMET Profiling Research Square · 2026-10-20 · Preprint — not yet peer-reviewed · usefulness score 16/100

See all studies in Treatments →