Safety, Tolerability, and Efficacy of Donepezil (Aricept) in Parkinson' s Disease (PD) Patients With Dementia

This study has been completed.
Sponsor:
Information provided by:
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT01327859
First received: March 30, 2011
Last updated: June 26, 2014
Last verified: March 2012
  Purpose

The purpose of this study is to evaluate the safety, tolerability, and efficacy of donepezil (Aricept) in Parkinson's Disease (PD) patients with dementia.


Condition Intervention Phase
Parkinson's Disease
Dementia
Drug: Prior Donepezil 5mg
Drug: Prior Donzepezil 10mg
Drug: Prior Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A 52-week, Multicentre Open Label Extension Study of the Safety Tolerability and Efficacy of Donepezil (Aricept) in Parkinson's Disease (PD) Patients With Dementia

Resource links provided by NLM:


Further study details as provided by Eisai Inc.:

Primary Outcome Measures:
  • Safety and tolerability will primarily be assessed by recording of AEs [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To assess the efficacy of open-label donepezil (5-10 mg/day) on cognition (ADAS) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • To assess the efficacy of open-label donepezil (5-10mg/day) on cognition(MMSE) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • To assess the efficacy of open-label donepezil (5-10 mg/day) on Global Function (CIBIC) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • To assess the efficacy of open-label donepezil (5-10 mg/day) on ADLs (DAD and Schwab and England scales) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • To assess the efficacy of open-label donepezil (5-10 mg/day) on behavior (NPI) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Enrollment: 357
Study Start Date: March 2003
Study Completion Date: July 2006
Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Prior Donepezil 5mg Drug: Prior Donepezil 5mg
Received 5 mg donepezil once daily during the preceding double-blind study, E2020-G000-316. Received open-label 5 or 10 mg donepezil during the present study.
Experimental: Prior Donepezil 10mg Drug: Prior Donzepezil 10mg
Received 10 mg donepezil once daily during the preceding double-blind study, E2020-G000-316 . Received open-label 5 or 10 mg donepezil during the present study.
Placebo Comparator: Prior Placebo Drug: Prior Placebo
Received placebo once daily during the preceding double-blind study, E2020-G000-316. Received open-label 5 or 10 mg donepezil during the present study.

Detailed Description:

Patients who complete all 24 weeks of the double-blind study E2020-E044-316 (NCT00165815) will be eligible for the open label extension study. Patients and caregiver/study partner will need to provide additional written informed consent to participate in the open label extension study. Safety and tolerability will be assessed after 4, 8 12, 24, 36 and 52 weeks. Cognition, Global Clinical Function, Activities of Daily Living, and Behaviour will be assessed after 24, and 52 weeks.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age range: patients must be aged 40 or over
  • Sex distribution: male and female
  • PD according to UK Brain Bank criteria 40 with good response to levodopa as judged by investigator opinion.
  • Women of child bearing potential must have demonstrated a negative serum beta human chorionic gonadotropin (B-HCG) at the screening visit for the double-blind study (E2020-E044-316)(NCT00165815) and a negative urine test result at the screening visit for the open label extension study, (E2020-E044-318)
  • Completed all 24 treatment weeks of the double-blind study E2020-E044-316 (NCT00165815)and completed assessments.
  • Outpatients, with a responsible and reliable caregiver/study partner
  • Health: generally healthy and ambulatory or ambulatory-aided (i.e., walker or cane); vision (glasses, contact lenses permissible), hearing (hearing aid permissible) and speech sufficient for compliance with testing procedures; must be capable of swallowing the study medication.
  • Written informed consent must be obtained from each patient and his/her caregiver/study partner prior to subjecting the patient or caregiver/study partner to any open label extension study related procedures.

Exclusion Criteria:

  • Pregnant or lactating, women.
  • Women of childbearing potential unless:

    • surgically sterile or
    • must be practicing effective contraception (e.g. abstinence, IUD or barrier method plus hormonal method). These patients must be willing to remain on current form of contraception for the duration of the study, (post menopausal women must be amenorrheic for at least 12 months to be considered of non-child bearing potential).
  • Patients with evidence of other psychiatric/neurological disorders, i.e., stroke, schizophrenia, seizure disorder, head injury with loss of consciousness (for at least 1 hour) within the past year, progressive supranuclear palsy, multisystem atrophy, or dementia complicated by other organic disease.
  • Evidence of clinically significant, active gastrointestinal, renal, hepatic, endocrine or cardiovascular system disease. Evidence of second or third degree heart block. Patients with controlled hypertension (supine diastolic blood pressure (BP) < 95 mmHg), right bundle branch block (complete or partial) and pacemakers may be included in the study.
  • Patients previously treated with centrally active acetylchlinesterase (AChE) inhibitors (e.g., physostigmine, tacrine, metrifonate, galantamine, rivastigmine, donepezil) except the medication in the Aricept double-blind study E2020-E044-316 (NCT00165815).
  • Patients and/or caregivers/study partners who are unwilling or unable to fulfill the requirements of the study.
  • Any condition which would make the patient or the caregiver/study partner, in the opinion of the investigator, unsuitable for the study.
  • Patients with known hypersensitivity to AChE inhibitors.
  • Patients who were non-compliant with the inclusion/exclusion criteria or with the study medication received in the preceding Aricept? double-blind study E2020-E044-316 (NCT00165815).
  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: NCT01327859

Locations
United Kingdom
Bath, Canterbury, United Kingdom, BA2 5RP
Sponsors and Collaborators
Eisai Inc.
Investigators
Study Director: Mark Harre Eisai Limited
  More Information

No publications provided

Responsible Party: Margaret Moline, PhD, Eisai Inc
ClinicalTrials.gov Identifier: NCT01327859     History of Changes
Other Study ID Numbers: E2020-E044-318, 2004-003355-39
Study First Received: March 30, 2011
Last Updated: June 26, 2014
Health Authority: United Kingdom: European Agency for the Evaluation of Medicinal Products

Additional relevant MeSH terms:
Parkinson Disease
Dementia
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
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 October 01, 2014