Study in Elderly Alzheimer's Patients to Assess Skin Tolerability, Irritation With 3, 7-Day Applications of DTP-System
Condition: Irritation/Irritant
Intervention: 350 mg Donepezil Transdermal Patch; Placebo Patch
Intervention description: Active and placebo patches will be applied to opposite sides for 7 days.; Active and placebo patches will be applied to opposite sides for 7 days.
Intervention MeSH terms: Donepezil
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 49.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: No
Keywords: Skin Irritation; Donepezil Transdermal Patch System; Elderly; Alzheimer's subjects; Skin Irritation in elderly Alzheimer's subjects

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.
    

Eligibility criteria:

        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 potential must use a condom.

          -  Must understand and provide written informed consent (or have a Legally Authorized
             Representative who is able), prior to the initiation of any protocol-specific
             procedures.

          -  Must be willing and able to abide by all study requirements and restrictions.

          -  Must be on stable medications for at least 30 days prior to enrollment into the study.

        Exclusion Criteria:

          -  Use of systemic or topical antihistamines within 72 hours prior to enrollment, or
             systemic or topical corticosteroids within 3 weeks of study enrollment or foreseen use
             during the study.

          -  History of allergy to Donepezil hydrochloride or to piperidine derivatives, related
             drugs, or any of the drug excipients or other drug product components.

          -  Those with a recent (< 2 years) cancer (except for non-melanoma skin cancers, females
             with in-situ cancer of the cervix or males with localized prostate cancer requiring no
             treatment).

          -  Presence of history of a psychiatric disorder, or other seizure disorder deemed
             clinically significant.

          -  Those with a known plan for elective surgery during the study period.

          -  Those taking antidepressant medication.

          -  Abnormality (e.g., scar, tattoo) or unhealthy skin (e.g., burns, wounds) at the
             application site; or an existing chronic skin disease or history of skin disease at
             the application site(s) within the 30 days prior to enrollment.

          -  Treatment with any investigational drug within 30 days prior to enrollment in the
             study.

          -  Any condition which would make the patient or caregiver, in the opinion of the
             investigator or designee, not suitable for the study for any reason.

          -  Current or pending legal charges that may affect patient or caregiver compliance.

          -  Treatment with medications contraindicated for use with Aricept