A 52-week, multicentre, open label extension study of the safety, tolerability and efficacy of donepezil (Aricept) in Parkinson's disease patients with dementia.
- Conditions
- Dementia associated with Parkinson's disease
- Registration Number
- EUCTR2004-003355-39-AT
- Lead Sponsor
- Eisai Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 468
a)Age range: patients must be aged 40 or over
b)Sex distribution: male and female
c)PD according to UK Brain Bank criteria40 with good response to levodopa as judged by investigator opinion.
d)Women of child bearing potential must have demonstrated a negative serum beta-HCG at the screening visit for the double-blind study (E2020-E044-316) and a negative urine test result at the screening visit for the open label extension study, (E2020-E044-318),
e)Completed all 24 treatment weeks of the double-blind study E2020-E044-316 and completed assessments.
f)Outpatients, with a responsible and reliable caregiver/study partner
g)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.
h)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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
a)Pregnant or lactating, women.
b)Women of childbearing potential unless (1) surgically sterile or (2) 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).
c)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.
d)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 BP < 95 mmHg), right bundle branch block (complete or partial) and pacemakers may be included in the study.
e)Patients previously treated with centrally active AChE inhibitors (e.g., physostigmine, tacrine, metrifonate, galantamine, rivastigmine, donepezil) except the medication in the Aricept® double-blind study E2020-E044-316.
f)Patients and/or caregivers/study partners who are unwilling or unable to fulfil the requirements of the study.
g)Any condition which would make the patient or the caregiver/study partner, in the opinion of the investigator, unsuitable for the study.
h)Patients with known hypersensitivity to AChE inhibitors.
i)Patients who were non-compliant with the inclusion/exclusion criteria or with the study medication received in the preceeding Aricept® double-blind study E2020-E044-316.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess the safety and tolerability (including an assessment of motor symptoms using the UPDRS) of open label 5-10 mg/day Aricept® in Parkinson's disease patients with dementia, who have completed the week 24 visit in the double-blind Aricept study E2020-E044-316.;Secondary Objective: To assess the efficacy of open label Aricept® (5-10mg/day) on cognitive and global clinical function in PD patients with dementia, assessed by the ADAS-cog scale, MMSE scale and CIBIC-plus scale respectively.<br><br>To assess the efficacy of open label Aricept® (5-10mg/day) on activities in daily living and behaviour.<br>;Primary end point(s): There is no primary end point as this is an open label extension study.
- Secondary Outcome Measures
Name Time Method