A Phase 1 interventional study of Donepezil TDS in Alzheimer's Disease, sponsored by Corium, Inc.. Completed at 1 site in United States. Open to participants aged 30 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-09-14.
Sponsored by Corium, Inc. · Phase 1, Interventional, and Treatment
Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →
Among 60 studies testing donepezil in Alzheimer Disease — 2 open to participants now, 2 under way, 1 of them phase 3. Donepezil · Alzheimer Disease.
Among the 60 studies testing donepezil in Alzheimer Disease, this one is the 50th largest by enrollment of the 58 interventional ones that give a count, is one of 3 that started in 2018, is one of 20 in phase 1, and was the 53rd registered.
3,968 studies on the registry are indexed under Alzheimer Disease; 928 are open to participants now.
Browse Alzheimer Disease studies →2 of the 60 studies testing donepezil in Alzheimer Disease are open now, in 1 country. Recruiting first, the newest first:
Assistance Publique - Hôpitaux de Paris · Sites in France
Ages 50+
Eisai Inc.
Ages 50–85
By country, each count listing its studies:
Donepezil: first FDA approval 1996 (ARICEPT). What it is approved for, and how studies give it, is on its page →
Of the 643 Alzheimer Disease studies recruiting now, 284 (44%) set no upper age limit and 55 (9%) stop at 75 or younger; 34 take children under 18; 285 take healthy volunteers.
This study: 30 Years and older · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
60 studies; the count open now beside each. This study's row is marked.
First in 1999; this study’s year is marked. 3 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 24 is below the median of 70 across 3,021 interventional studies indexed under Alzheimer Disease.
Median enrollment 79 across the 58 interventional studies. Of the 56 that completed or were terminated, 21 (38%) have results posted.
This tab as a report to print or save as PDF → With an account.
39 of 60 have an industry lead sponsor. The 10 most frequent:
Corium, Inc. is the lead sponsor of 8 studies on the registry; none are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 3 (43%) have results posted.
Corium, Inc. has 4 studies filed under Alzheimer Disease — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 60 studies testing donepezil in Alzheimer Disease, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
A study to assess the effect of heat application on the delivery profile of Corplex™ Donepezil Transdermal Delivery System (TDS)
2-Way Crossover study
Approximately 24 healthy, adult male and female subjects will be enrolled.
Subjects will be randomized to 1 of 2 treatment sequences prior to the first TDS application in treatment period 1.
For each treatment period, subjects will have one 7-day TDS applied on their back. Depending on which sequence a subject is randomized to, the healthy subject will either be exposed to heat or not during the TDS wear time.
Blood samples for Donepezil PK will be collected pre-dose until the end of each treatment period.
Adhesion will be monitored throughout the TDS wear time, and skin irritation will be monitored after TDS removal.
Subjects who complete the 2-way crossover study may be eligible to participate in the optional Study Extension Period. In the Study Extension Period, subjects will have their skin surface temperature monitored under the patch and adjacent to the TDS.
Blood samples for Donepezil PK will not be collected, and adhesion will not be monitored for the Study Extension TDS wear period.
Safety will be monitored throughout the study by adverse event reporting and repeated clinical and laboratory evaluations.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corplex Donepezil TDS 5 mg/day with heat applied
Drug: Donepezil TDS
Corplex Donepezil TDS 5 mg/day with no heat applied
Drug: Donepezil TDS
Corplex Donepezil TDS 5 mg/day with heat. Two skin sensors will be placed underneath the TDS and adjacent to the TDS.
Drug: Donepezil TDS
Donepezil Hydrochloride Transdermal Delivery System
Pharmacokinetics, Cmax
Peak plasma concentration (Cmax) of once-weekly Donepezil TDS in the presence and absence of heat
Time frame: Blood samples for donepezil PK will be collected pre-dose until the end of each treatment period, approximately 6 weeks total
Pharmacokinetics, AUC
Area under the curve (AUC) of once-weekly Donepezil TDS in the presence and absence of heat
Time frame: Blood samples for the Donepezil PK will be collected pre-dose until the end of each treatment period, approximately 6 weeks total
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
General safety (adverse events and serious adverse events as reported by subject following guidance CTCAE v4.0)
Time frame: Daily during 1 week treatment period and during the 5 week follow-on period
Summary Listing of Skin Irritation Score of Donepezil TDS by post-removal time point
Skin irritation score is determined by the sum of Dermal Response score (8-point categorical scale; where 0=no evidence of irritation to 7=strong reaction) using numeric values and Other Effects score (6-point categorical scale where 0=none observed to H=scabs/erosion) using alphabet letters equivalent to numeric values and summarized by the presence and absence of heat
Time frame: 0.5 hr, 24 hr, 48 hr, 72 hr after each TDS removal (3 days)
Application Site Mean Adhesion Scores of Donepezil TDS
Adhesion data will be collected during each 7-day patch wear period
Time frame: Daily during 1 week treatment period
Plan to share: No — No plans
No publications or documents are linked to this record.
Ran from Feb 2018 to primary completion in Jun 2018, 4 months.
Of 161 industry-sponsored phase 1 interventional studies under Alzheimer Disease, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 23. This study's 4 months is below that.
Counting every sponsor, half of 234 studies reached it within 18 months; a quarter within 7 and three quarters within 39.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Donepezil