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

NCT ID: NCT01327859

Last Updated: 2015-11-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 357 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-03-31
• Study Completion Date: 2006-07-31

Brief Summary

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

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.

Conditions

Parkinson's Disease; Dementia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Prior Donepezil 5mg

Group Type: EXPERIMENTAL

Prior Donepezil 5mg

Intervention Type: DRUG

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.

Prior Donepezil 10mg

Group Type: EXPERIMENTAL

Prior Donzepezil 10mg

Intervention Type: DRUG

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.

Prior Placebo

Group Type: PLACEBO_COMPARATOR

Prior Placebo

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eisai Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Eisai Inc

Principal Investigators

Mark Harre

Role: STUDY_DIRECTOR

Eisai Limited

Locations

Bath, Canterbury, United Kingdom

Countries

United Kingdom

Other Identifiers

2004-003355-39

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

E2020-E044-318

Identifier Type: -

Identifier Source: org_study_id