A Phase 1 interventional study of Donepezil TDS and Aricept 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 2018-08-01.
Sponsored by Corium, Inc. · Phase 1, Interventional, and Treatment
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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 29th largest by enrollment of the 58 interventional ones that give a count, is one of 2 that started in 2017, is one of 20 in phase 1, and was the 51st 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. 2 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 86 is above 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.
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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 steady-state bioequivalence of once-weekly Corplex™ Donepezil 10 mg Transdermal Delivery System (TDS) compared to daily administration of Aricept®
Open label, randomized, 2-period, multiple-dose crossover study.
Approximately 86 healthy, adult male and female subjects will be enrolled.
Subjects will be randomized to 1 of 2 treatment sequences prior to the first study product treatment in treatment period 1.
For each treatment period; subjects will receive donepezil for 5 consecutive weeks. Blood samples for donepezil PK will be collected pre-dose through week 10.
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:
Any of the following drugs for 28 days prior to the first dose of study drug in Treatment Period 1 and throughout the study:
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).
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
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.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corplex Donepezil TDS 5 mg/day followed by Donepezil TDS 10mg/day applied weekly for 5 consecutive weeks
Drug: Donepezil TDS
Aricept 5 mg/day followed by Aricept 10 mg/day once daily for 5 consecutive weeks
Drug: Aricept
Donepezil Hydrochloride Transdermal Delivery System
Aricept Tablet
PK, AUC
To assess the plasma concentration (AUC) of once-weekly Corplex Donepezil (TDS) compared to once-daily (QD) administration of Aricept (donepezil hydrochloride \[HCl\]).
Time frame: Blood samples for donepezil PK will be collected pre dose until the end of each treatment period, approximately 10 weeks total
PK, Cmax
To assess the maximum observed concentrations (Cmax) of once-weekly Corplex Donepezil (TDS) compared to once-daily (QD) administration of Aricept (donepezil hydrochloride \[HCl\]).
Time frame: Blood samples for donepezil PK will be collected pre dose until the end of each treatment period, approximately 10 weeks total
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
General Safety (AE and SAE as reported by subject following guidance CTCAE v4.0)
Time frame: Daily during 5 week treatment period and during the 5 week follow-on period
PI assessment of local skin irritation response to TDS
To evaluate the safety and tolerability (including local skin irritation) of once-weekly Corplex Donepezil TDS. Dermal Response assessed using 8 point categorical scale. Other effects assessed using a 6 point scale.
Time frame: 0.5hr, 24hr, 48hr and 72hr after each TDS removal. (5 consecutive weeks)
PI assessment of TDS Adhesion
Adhesion data will be collected during each 7-day patch wear period throughout 5 week treatment period. Percent adherence will be assessed using 12 point categorical scale.
Time frame: Daily during 5 week treatment period
Plan to share: No — No Plans
No publications or documents are linked to this record.
Ran from Oct 2017 to primary completion in Mar 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 Jul 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Donepezil