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 2018-08-07.
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 31st 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 52nd 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 66 is close to 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 Phase 1, Crossover Study to Evaluate the Pharmacokinetics of Corplex™ Donepezil 10 mg Transdermal Delivery System Applied to Different Body Locations
Randomized, open-label, 3-way crossover study
Up to 66 healthy, adult male and female subjects will be enrolled.
All subjects will receive Corplex Donepezil TDS patches applied to 3 different locations on each subject (back, buttock, and leg) during 3 different, consecutive treatment periods. For each subject, the location of product administration during each treatment period will be randomized.
During each treatment period, all subjects will receive a once-weekly 10 mg TDS, target dose 10 mg donepezil/day, applied for 7 days (1 week) on either the back, buttock, or leg in accordance with the randomized treatment location for that treatment period.
Blood samples for donepezil PK will be collected pre-dose until the end of each treatment period. The PK sample collection time points are as follows:
Week 1: Pre-TDS application prior to 0 hour and post-TDS application at 2, 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, and 156 hours.
Week 2: Pre-Week 1 TDS removal at 168 hours, and post-TDS removal at up to 528 hours
Adhesion and skin irritation will be monitored throughout TDS treatments. Safety will be monitored throughout the study by adverse event reporting, repeated clinical and laboratory evaluations.
Inclusion Criteria:
Key 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.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
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.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corplex Donepezil TDS 10 mg/day applied to the Back for 1 week (7 days)
Drug: Donepezil TDS
Corplex Donepezil TDS 10 mg/day applied to the Buttock for 1 week (7 days)
Drug: Donepezil TDS
Corplex Donepezil TDS 10 mg/day applied to the Leg for 1 week (7 days)
Drug: Donepezil TDS
Donepezil Hydrochloride Transdermal Delivery System
Pharmacokinetics, AUC
Area under the plasma concentration versus time curve (AUC) of once-weekly Corplex Donepezil TDS applied to different body locations.
Time frame: Blood samples for donepezil PK will be collected pre-dose until the end of each treatment period, approximately 18 weeks total
Pharmacokinetics, CMAX
Peak Plasma Concentration (Cmax) of once-weekly Corplex Donepezil TDS applied to different body locations.
Time frame: Blood samples for donepezil PK will be collected pre-dose until the end of each treatment period, approximately 18 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 throughout the 5 week period
Summary Listing of Skin Irritation Score of Donepezil Corplex 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 the 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 application site (back, buttock and leg)
Time frame: 0.5hr, 24hr, 48hr and 72hr after each TDS removal. (3 days)
Application Site Mean Adhesion Scores of Donepezil Corplex TDS
Adhesion score is collected using a 12-point categorical scale, where 0=100% adhered to 11=detached
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 Jan 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 Aug 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