Study in Elderly Alzheimer's Subjects 3 Consecutive 7-Day Applications of 350mg DTP-Donepezil Transdermal Patch-System (DTP-System)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Teikoku Pharma USA
ClinicalTrials.gov Identifier:
NCT00916383
First received: June 5, 2009
Last updated: June 15, 2012
Last verified: June 2012
  Purpose

This study is designed to assess skin irritation, skin tolerability and adhesion of the 350 mg Donepezil Transdermal Patch System (DTP-system), following three 7-day applications to three separate specific areas of the body (upper back, upper middle arm, side of torso) of elderly Alzheimer's subjects. The total application time for the DTP-system is 21 days.


Condition Intervention Phase
Irritation/Irritant
Drug: 350 mg Donepezil Transdermal Patch System (DTP-System)
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Randomized, Placebo-Controlled Study in Elderly Alzheimer's Subjects on Established/Well Tolerated Dose of Aricept to Assess Skin Tolerability, Skin Irritation and Adhesion (3 Consecutive 7-Day Applications of 350mg DTP-System

Resource links provided by NLM:


Further study details as provided by Teikoku Pharma USA:

Primary Outcome Measures:
  • To evaluate the primary skin irritation and tolerability of the 350 mg DTP-system on the skin of elderly Alzheimer's subjects who are on an established well tolerated oral dose of Aricept 10 mg, for a period of at least 2 months. [ Time Frame: 0, 1, 24 and 48 Hours post patch removal ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The secondary objectives of this study are adhesion, safety, and tolerability of the 350 mg DTP-system. [ Time Frame: Adhesion and Safety is assessed daily for 21 days ] [ Designated as safety issue: Yes ]

Enrollment: 48
Study Start Date: April 2009
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Donepezil
350 mg Donepezil Transdermal Patch System: active comparator and placebo Donepezil Transdermal Patch system: placebo comparator.
Drug: 350 mg Donepezil Transdermal Patch System (DTP-System)
DTP-System (active and placebo) will be applied once every 7 days for 21 days
Other Name: Aricept

Detailed Description:

This is a randomized, placebo-controlled study designed to assess the primary skin irritation, skin tolerability and adhesion of the 350 mg DTP-system, following three 7-day applications to three separate specific areas of the body (upper back, upper middle arm, side of torso) of elderly Alzheimer's subjects. The total application time for the DTP-system is 21 days.

Subjects who meet all enrollment criteria after screening will be enrolled and randomized into the study on Day 1. Application of the patch-systems will be 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. Subjects will be seen in the clinic for Screening, Days 1, 8, 15, 22 and the End of Study Visit; for all other daily visits, the subjects may be seen either at the clinic or in their residence, provided the assessments are completed as described in the protocol. Skin irritation scoring will be obtained on the days the patch-system is removed, immediately upon removal and at hours 1, 24 and 48 hours after removal.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female subjects at least 65 years of age.
  • Established dose Aricept 10 mg at least 2 months prior to enrollment.
  • Established diagnosis of 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. Subjects with well-controlled hypertension (with medication) may enroll as long as 3-month stability criteria are met.
  • Those with stable cardiac disease may be enrolled provided the subject 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 subject or is in daily contact with the subject, 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 subject's ability to participate.
  • Free of any dermatologic conditions, excessive hair or skin allergies and sensitivities.
  • Male subjects 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 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 subject 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 subject or caregiver compliance.
  • Treatment with medications contraindicated for use with Aricept
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00916383

Locations
United States, Arizona
Xenoscience, Inc
Phoenix, Arizona, United States, 85004
United States, California
Margolin Brain Institute
Fresno, California, United States, 93720
Collaborative Neuroscience Network, Inc
Garden Grove, California, United States, 92845
Synergy Clinical Research Center
National City, California, United States, 91950
Apex Research Institute
Santa Ana, California, United States, 92705
United States, Florida
Meridien Research
Brooksville, Florida, United States, 34613
Miami Jewish Home and Hospital
Miami, Florida, United States, 33173
Sponsors and Collaborators
Teikoku Pharma USA
  More Information

No publications provided

Responsible Party: Teikoku Pharma USA
ClinicalTrials.gov Identifier: NCT00916383     History of Changes
Other Study ID Numbers: TPU-TAD-US02-0810
Study First Received: June 5, 2009
Last Updated: June 15, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Teikoku Pharma USA:
Skin Irritation
Donepezil Transdermal Patch System
Elderly
Alzheimer's subjects
Skin Irritation in elderly Alzheimer's subjects

Additional relevant MeSH terms:
Donepezil
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 23, 2014