Study in Elderly Alzheimer's Patients to Assess Skin Tolerability, Irritation With 3, 7-Day Appli… (NCT00916383) | Clinical Trial Compass
CompletedPhase 2
Study in Elderly Alzheimer's Patients to Assess Skin Tolerability, Irritation With 3, 7-Day Applications of DTP-System
United States49 participantsStarted 2009-05
Plain-language summary
This study is designed to assess skin tolerability, skin irritation, and adhesion of the 350 mg Donepezil Transdermal Patch (DTP-system), following 3, 7-day applications to 3 specific areas of the body (upper back, upper middle arm, side of torso) of elderly Alzheimer's patients. The total application time for the DTP-system is 21 days.
Who can participate
Age range
65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Male or female at least 65 years of age.
* Established dose of Aricept 10 mg at least 2 months prior to enrollment.
* Established diagnosis of stable Alzheimer's disease treated with oral Aricept
* Must be willing to change from oral Aricept to DTP (and placebo patch).
* Body mass index of at least 18 and a minimum weight of at least 45 kg.
* Blood pressure (sitting) must be diastolic \<95mmHg, and systolic \<145, stable for at least 3 months. Patients with well-controlled hypertension (with medication) may enroll as long as 3-month stability criterion is met.
* Those with stable cardiac disease may be enrolled provided the patient has been on appropriate medication for 3 months prior to screening. Those with a pacemaker may be enrolled.
* Pulse rate between 45 - 100 bpm; respirations between 8 - 20 per minute.
* Those with thyroid disease may enroll if stable on treatment for at least 3 months prior to screening, and maintain the same dose of thyroid medication throughout the study.
* Must have a caregiver who is either living with the patient or is in daily contact with the patient, agrees to be present at all visits, provide information as required, and ensure compliance with the medication schedule.
* Free from any abnormality at Screening which may compromise the patient's ability to participate.
* Free of any dermatologic conditions, excessive hair or skin allergies and sensitivities.
* Male patients who have female partners of childbearing potent…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Skin Irritation (Erythema and Edema)
Timeframe: Immediately after patch removal
2
Skin Irritation (Erythema)
Timeframe: 1, 24, and 48 hours after patch removal (Days 8-10; Days 15-17; Days 22-24)
3
Skin Irritation (Edema)
Timeframe: 1, 24, and 48 hours after patch removal (Days 8-10; Days 15-17; Days 22-24)
4
Skin Irritation (Papules and Vesicles)
Timeframe: Immediately after patch removal
5
Skin Irritation (Papules and Vesicles)
Timeframe: 1, 24, and 48 hours after patch removal (Days 8-10; Days 15-17; Days 22-24)
6
Skin Irritation (Other Skin Effects)
Timeframe: Immediately after patch removal
7
Skin Irritation (Other Skin Effects)
Timeframe: 1, 24, and 48 hours after patch removal (Days 8-10; Days 15-17; Days 22-24)