Conditions: Irritation/Irritant
Keywords: Skin Irritation Donepezil Transdermal Patch System Elderly Alzheimer's subjects Skin Irritation in elderly Alzheimer's subjects
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 49
Healthy volunteers: no

Brief 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.

Detailed description:
This is a randomized, placebo-controlled study designed to evaluate skin irritation, skin tolerability, and adhesion of the 350 mg DTP-system following 3 consecutive 7-day applications to 3 specific areas of the body (upper back, upper arm, side of torso) of elderly Alzheimer's patients. The total exposure time for the DTP-system is 21 days.

All patients receive 1 Donepezil Transdermal Patch (DTP-system) and 1 placebo patch, each applied to opposite sides of the body (e.g., placebo patch to the left side of the upper back, and DTP-system to the right side of the upper back). Patients are randomized to receive the active patch to either the left or the right side of the body according to 1 of 6 treatment sequences listed below. The treatment sequence is repeated for the opposite side of the body for a total of 12 treatment sequences (4 patients in each treatment sequence). The patches are applied to one of 3 body locations for 7 days, for a total exposure period of 21 days, according to one of the following sequences:

1. Upper Back, Upper Arm, Side of Torso (Right)
2. Upper Arm, Side of Torso, Upper Back (Right)
3. Side of Torso, Upper Back, Upper Arm (Right)
4. Upper Back, Side of Torso, Upper Arm (Right)
5. Upper Arm, Upper Back, Side of Torso (Right)
6. Side of Torso, Upper Arm, Upper Back (Right)
7. Upper Back, Upper Arm, Side of Torso (Left)
8. Upper Arm, Side of Torso, Upper Back (Left)
9. Side of Torso, Upper Back, Upper Arm (Left)
10. Upper Back, Side of Torso, Upper Arm (Left)
11. Upper Arm, Upper Back, Side of Torso (Left)
12. Side of Torso, Upper Arm, Upper Back (Left)

Patches are applied on Days 1, 8, and 15 according to the randomization schedule. Oral Aricept is taken daily through Day -1, and is re-started on Day 22 or at the time of early termination if before Day 22. Patients are seen in the clinic at Screening and on Days 1, 8, 15, 22, and at the End of Study Visit; for all other daily visits, the patients may be seen either at the clinic or in their residence, provided the assessments are completed as described in the protocol. Skin irritation is assessed immediately upon patch removal and at 1, 24, and 48 hours after removal.

Arms:
arm 1: 350 mg Donepezil Transdermal Patch (active) and placebo patch, each applied to opposite sides of the upper back. arm 2: 350 mg Donepezil Transdermal Patch (active) and placebo patch, each applied to opposite arms. arm 3: 350 mg Donepezil Transdermal Patch (active) and placebo patch, each applied to opposite sides of torso.

Interventions: intervention 1: 350 mg Donepezil Transdermal Patch intervention 2: Placebo Patch
Intervention descriptions: intervention 1: Active and placebo patches will be applied to opposite sides for 7 days. intervention 2: Active and placebo patches will be applied to opposite sides for 7 days.

Protocol document: