- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01327859
Safety, Tolerability, and Efficacy of Donepezil (Aricept) in Parkinson' s Disease (PD) Patients With Dementia
November 2, 2015 updated by: Eisai Inc.
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
The purpose of this study is to evaluate the safety, tolerability, and efficacy of donepezil (Aricept) in Parkinson's Disease (PD) patients with dementia.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
357
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Canterbury
-
Bath, Canterbury, United Kingdom, BA2 5RP
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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
|
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
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Safety and tolerability will primarily be assessed by recording of AEs
Time Frame: 52 weeks
|
52 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To assess the efficacy of open-label donepezil (5-10 mg/day) on cognition (ADAS)
Time Frame: 52 weeks
|
52 weeks
|
To assess the efficacy of open-label donepezil (5-10mg/day) on cognition(MMSE)
Time Frame: 52 weeks
|
52 weeks
|
To assess the efficacy of open-label donepezil (5-10 mg/day) on Global Function (CIBIC)
Time Frame: 52 weeks
|
52 weeks
|
To assess the efficacy of open-label donepezil (5-10 mg/day) on ADLs (DAD and Schwab and England scales)
Time Frame: 52 weeks
|
52 weeks
|
To assess the efficacy of open-label donepezil (5-10 mg/day) on behavior (NPI)
Time Frame: 52 weeks
|
52 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Mark Harre, Eisai Limited
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2003
Primary Completion (Actual)
July 1, 2006
Study Completion (Actual)
July 1, 2006
Study Registration Dates
First Submitted
March 30, 2011
First Submitted That Met QC Criteria
April 1, 2011
First Posted (Estimate)
April 4, 2011
Study Record Updates
Last Update Posted (Estimate)
November 3, 2015
Last Update Submitted That Met QC Criteria
November 2, 2015
Last Verified
November 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurocognitive Disorders
- Parkinsonian Disorders
- Basal Ganglia Diseases
- Movement Disorders
- Synucleinopathies
- Neurodegenerative Diseases
- Parkinson Disease
- Dementia
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Cholinergic Agents
- Enzyme Inhibitors
- Nootropic Agents
- Cholinesterase Inhibitors
- Donepezil
Other Study ID Numbers
- E2020-E044-318
- 2004-003355-39 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Parkinson's Disease
-
Ohio State UniversityCompletedParkinson's Disease | Parkinson Disease | Idiopathic Parkinson Disease | Idiopathic Parkinson's Disease | Parkinson Disease, Idiopathic | Parkinson's Disease, IdiopathicUnited States
-
Assistance Publique - Hôpitaux de ParisFrance Parkinson AssociationUnknownHealthy Controls | Parkinson's Disease With LRRK2 Mutation | Parkinson's Disease Without LRRK2 MutationFrance
-
Merck Sharp & Dohme LLCCompletedParkinson Disease | Idiopathic Parkinson Disease | Idiopathic Parkinson's Disease
-
Universidade Federal de PernambucoCompletedParkinson's Disease.Brazil
-
University Hospital, GrenobleCompletedParkinson's Disease (Disorder)France
-
Neurocrine BiosciencesVoyager TherapeuticsCompletedBrain Diseases | Central Nervous System Diseases | Nervous System Diseases | Parkinson's Disease | Parkinsonian Disorders | Movement Disorders | Neurodegenerative Diseases | Idiopathic Parkinson's Disease | Basal Ganglia DiseaseUnited States
-
Second Affiliated Hospital of Soochow UniversityShanghai Regenelead Therapies Co., Ltd.RecruitingAdvanced Parkinson's DiseaseChina
-
AbbVieRecruitingParkinson's Disease (PD)Germany, Denmark, Spain
-
Beijing Tiantan HospitalRecruitingPD - Parkinson's DiseaseChina
-
Hubert FernandezRecruitingParkinson's Disease, IdiopathicUnited States
Clinical Trials on Prior Donepezil 5mg
-
Samsung Medical CenterDong-A Pharmaceutical Co., Ltd.Unknown
-
Shanghai Synergy Pharmaceutical Sciences Co., Ltd.Completed
-
Merck Sharp & Dohme LLCCompleted
-
Merck Sharp & Dohme LLCTerminated
-
Eisai Co., Ltd.Completed
-
University of EdinburghNHS LothianCompleted
-
Vigonvita Life SciencesCompletedErectile DysfunctionChina
-
Hospices Civils de LyonCompletedCartilage Ulceration of the Distal JointsFrance
-
Eisai Inc.Eisai LimitedCompleted
-
Eisai Co., Ltd.CompletedDementia With Lewy Bodies (DLB)Japan