Ignite Creation Date:
2025-12-25 @ 12:21 AM
Ignite Modification Date:
2025-12-25 @ 10:25 PM
Study NCT ID:
NCT01014858
Status:
TERMINATED
Last Update Posted:
2017-09-25
First Post:
2009-11-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Multi-centre UK Study of the Acetylcholinesterase Inhibitor Donepezil in Early Dementia Associated With Parkinson's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}], 'ancestors': [{'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077265', 'term': 'Donepezil'}], 'ancestors': [{'id': 'D007189', 'term': 'Indans'}, {'id': 'D007192', 'term': 'Indenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'whyStopped': 'Due to low recruitment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-09-21', 'studyFirstSubmitDate': '2009-11-16', 'studyFirstSubmitQcDate': '2009-11-16', 'lastUpdatePostDateStruct': {'date': '2017-09-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-11-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "To demonstrate the superiority of donepezil over placebo in improving cognitive function, neuropsychiatric burden and functional ability in people with Parkinson's disease and mild dementia after 24 months of treatment.", 'timeFrame': 'After 24 month of treatment'}], 'secondaryOutcomes': [{'measure': 'To demonstrate the superiority of donepezil over placebo in improving patient and carer quality of life and to establish the cost-effectiveness of donepezil.', 'timeFrame': '26, 52 and 104 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ["Parkinson's disease", 'mild dementia', 'donepezil', 'NIHR HTA'], 'conditions': ["Parkinson's Disease"]}, 'descriptionModule': {'briefSummary': "To demonstrate the superiority of donepezil over placebo in improving cognitive function, neuropsychiatric burden and functional ability in people with Parkinson's disease and mild dementia after 24 months of treatment.\n\nTo demonstrate the superiority of donepezil over placebo in improving patient and carer quality of life and to establish the cost-effectiveness of donepezil.\n\nTo determine the instrument most suitable for evaluating change in cognition in people with Parkinson's disease and mild dementia."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. A diagnosis of Parkinson\'s disease according to UK Parkinson\'s Disease Society Brain Bank Criteria. These criteria are in standard use throughout the NHS in the UK and were supported by the NICE guidelines.\n2. People with mild dementia associated with PD, where the patient and/or their family have become aware of cognitive with or without behavioural symptoms that are causing functional impairment. "Dementia" will be defined according to recently published Movement Disorder Society Task Force criteria for dementia associated with Parkinson\'s Disease and "operationalised" using the Addenbrooke\'s Cognitive Examination (ACE-R). The ACE-R permits some description of the dementia profile and also quantifies global impairment. It is increasingly used by clinicians in the UK to identify demented subjects, is relatively quick to perform (15 minutes or so), requires no specific training and produces a total score (0-100), from which the MMSE (0-30) can also be extracted. Participants will have an ACE-R of 88 or less. If this criterion is met, subjects will be further assessed using the Mattis Dementia Rating Scale (DRS-2). An age- and education-corrected total DRS-2 score of less than 8 but greater than 4 (corresponding to between the 6th and 28th percentile) will be used to define "mild" dementia".\n3. Community-living and a spouse, close relative or well established carer to accompany the subject to act as an informant.\n4. Where relevant, women of child bearing potential must be using adequate contraception for duration of study.\n\nExclusion Criteria:\n\n1. Dementia that develops within one year of the onset of motor symptoms. The reason for this "one year rule" is to specifically exclude participants with Dementia with Lewy Bodies (DLB). This exclusion criterion is consistent with recommendations made in the Movement Disorder Society Dementia Task Force Diagnostic Criteria and the Third Report of the DLB Consortium.\n2. People with such severe motor disability, or who are so impaired in their activities of daily living from other aspects of their PD, that it would interfere with cognitive and global assessments.\n3. Severe current depressive episode. Low mood may impact upon accurate cognitive assessment and major depression is therefore listed as a feature which, when present, makes it impossible to reliably diagnose PDD in the Movement disorder Society Task Force PDD Criteria. This will be operationalised using the self-completed Beck Depression Inventory and a cut-off score of 13, as recommended by a recent Movement Disorder Society Task Force report. The BDI score is considered robust in the face of mild to moderate cognitive impairment.\n4. Unstable significant medical co-morbidity.\n5. Patient receiving an anticholinergic drug for control of parkinsonian motor symptoms.\n6. Previous exposure to a cholinesterase inhibitor\n7. Presence of a condition that is contraindicative to use of donepezil (including a clinically significant cardiac conduction defect found in patient history or from screening ECG); see SmPC (Appendix W) for details.\n8. Allergy/hypersensitivity to excipients of donepezil or placebo\n9. Patient receiving the N-methyl-d-aspartate antagonist memantine.\n10. Previous neurosurgery for Parkinson\'s disease. This will apply to only a small minority of predominantly younger cases. The main reason for this exclusion relates to ongoing uncertainty over the potential confounding effects of deep brain stimulation upon both mood and cognition.'}, 'identificationModule': {'nctId': 'NCT01014858', 'acronym': 'MUSTARDD-PD', 'briefTitle': "Multi-centre UK Study of the Acetylcholinesterase Inhibitor Donepezil in Early Dementia Associated With Parkinson's Disease", 'organization': {'class': 'OTHER', 'fullName': 'Newcastle-upon-Tyne Hospitals NHS Trust'}, 'officialTitle': "Multi-centre UK Study of the Acetylcholinesterase Inhibitor Donepezil in Early Dementia Associated With Parkinson's Disease", 'orgStudyIdInfo': {'id': '5137'}, 'secondaryIdInfos': [{'id': '08/13/14', 'type': 'OTHER_GRANT', 'domain': 'NIHR Health Technology Assessment Programme 08/13/14'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Donepezil', 'description': '5mg of Donepezil for the first 8 weeks raising to 10mg thereafter if patient adjusted to 5mg dose. 10mg does continues for the remainder of the study.', 'interventionNames': ['Drug: Donepezil']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Patient commences medication to match appearance of 5mg donepezil for first 8 weeks then 10mg for the remainder of the study.', 'interventionNames': ['Drug: Donepezil']}], 'interventions': [{'name': 'Donepezil', 'type': 'DRUG', 'description': '5mg donepezil daily for first 8 weeks and then increased to 10mg daily for the remainder of the study.', 'armGroupLabels': ['Donepezil', 'Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'NE4 5PL', 'city': 'Newcastle upon Tyne', 'state': 'Tyne and Wear', 'country': 'United Kingdom', 'facility': 'Newcastle', 'geoPoint': {'lat': 54.97328, 'lon': -1.61396}}, {'zip': 'BA1 3NG', 'city': 'Bath', 'country': 'United Kingdom', 'facility': 'Royal United Hospital (RUH) Bath NHS', 'geoPoint': {'lat': 51.3751, 'lon': -2.36172}}, {'zip': 'B18 7QH', 'city': 'Birmingham', 'country': 'United Kingdom', 'facility': 'Sandwell and West Birmingham NHS Foundation Trust', 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}, {'zip': 'BS10 5NB', 'city': 'Bristol', 'country': 'United Kingdom', 'facility': 'Steps and Pines, Southmead Hospital', 'geoPoint': {'lat': 51.45523, 'lon': -2.59665}}, {'zip': 'BL9 7TD', 'city': 'Bury', 'country': 'United Kingdom', 'facility': 'Pennine Acute Hospitals NHS Trust', 'geoPoint': {'lat': 53.6, 'lon': -2.3}}, {'zip': 'CB2 0PY', 'city': 'Cambridge', 'country': 'United Kingdom', 'facility': 'Cambridge Centre for Brain Repair', 'geoPoint': {'lat': 52.2, 'lon': 0.11667}}, {'zip': 'DE22 3NE', 'city': 'Derby', 'country': 'United Kingdom', 'facility': 'Dr Lakmali Sugathapala', 'geoPoint': {'lat': 52.92277, 'lon': -1.47663}}, {'zip': 'BH23 2JX', 'city': 'Dorset', 'country': 'United Kingdom', 'facility': 'Royal Bournemouth & Christchurch Hospitals NHS Foundation Trust'}, {'zip': 'G51 4TF', 'city': 'Glasgow', 'country': 'United Kingdom', 'facility': 'NHS Greater Glasgow and Clyde', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}, {'zip': 'Gloucester', 'city': 'Gloucester', 'country': 'United Kingdom', 'facility': 'Dr Pippa Metcalf', 'geoPoint': {'lat': 51.86568, 'lon': -2.2431}}, {'zip': 'LL30 1LB', 'city': 'Llandudno', 'country': 'United Kingdom', 'facility': 'Llandudno Hospital, Betsi Cadwaladr University Health Board & School of Medical Sciences', 'geoPoint': {'lat': 53.32498, 'lon': -3.83148}}, {'zip': 'SE59RS', 'city': 'London', 'country': 'United Kingdom', 'facility': "King's College Hospital NHS Foundtion Trust", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'M8 5RB', 'city': 'Manchester', 'country': 'United Kingdom', 'facility': 'Manchester Mental Health & Social Care NHS Trust', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}, {'zip': 'MK6 5LD', 'city': 'Milton Keynes', 'country': 'United Kingdom', 'facility': 'Milton Keynes', 'geoPoint': {'lat': 52.04172, 'lon': -0.75583}}, {'zip': 'NP20 2UB', 'city': 'Newport', 'country': 'United Kingdom', 'facility': 'Royal Gwent Hospital', 'geoPoint': {'lat': 51.58774, 'lon': -2.99835}}, {'zip': 'NE29 8NH', 'city': 'Northumberland', 'country': 'United Kingdom', 'facility': 'North Tyneside General Hospital'}, {'zip': 'NR4 7UY', 'city': 'Norwich', 'country': 'United Kingdom', 'facility': 'Norfolk and Norwich University Hospitals NHS Foundation Trust', 'geoPoint': {'lat': 52.62783, 'lon': 1.29834}}, {'zip': 'OX3 9DU', 'city': 'Oxford', 'country': 'United Kingdom', 'facility': 'Oxford University Hospitals NHS Foundation Trust', 'geoPoint': {'lat': 51.75222, 'lon': -1.25596}}, {'zip': 'PL6 8DH', 'city': 'Plymouth', 'country': 'United Kingdom', 'facility': 'Plymouth Hospitals NHS Trust', 'geoPoint': {'lat': 50.37153, 'lon': -4.14305}}, {'zip': 'BH15 2JB', 'city': 'Poole', 'country': 'United Kingdom', 'facility': 'Poole Hospital NHS Trust', 'geoPoint': {'lat': 50.71429, 'lon': -1.98458}}, {'zip': 'SO16 6YD', 'city': 'Southampton', 'country': 'United Kingdom', 'facility': 'Southampton General Hospital', 'geoPoint': {'lat': 50.90395, 'lon': -1.40428}}, {'zip': 'KT16 0PZ', 'city': 'Surrey', 'country': 'United Kingdom', 'facility': 'Dr Dhakam'}], 'overallOfficials': [{'name': 'David J Burn, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Newcastle University'}, {'name': 'Roger A Barker, Dr', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cambridge University'}, {'name': 'Belinda Braithwaite, Mrs', 'role': 'STUDY_DIRECTOR', 'affiliation': 'lay person'}, {'name': 'Alistair Burns, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'School of Community Based Medicine, University of Manchester'}, {'name': 'Carl E Clarke, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Clarke'}, {'name': 'Elaine McColl, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Newcastle Upon-Tyne'}, {'name': 'John V Hindle, Dr', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Llandudno Hospital & University of College Wales'}, {'name': 'Martin Knapp, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'London School of Economics and Political Science'}, {'name': 'Andrew J Lees, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University College, London'}, {'name': 'Iracema Leroi, DR', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Lancashire Care Trust, Royal Blackburn Hospital'}, {'name': 'Ian G McKeith, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Newcastle University'}, {'name': "John T O'Brien, Professor", 'role': 'STUDY_DIRECTOR', 'affiliation': 'Newcastle University'}, {'name': 'Keith Wheatley, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cancer Research UK Clinical Trials Unit, School of Cancer Sciences, University of Birmingham'}, {'name': 'Ian N Steen, Dr', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Newcastle Upon-Tyne'}, {'name': 'Jennifer Wilkinson, Mrs', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Newcastle Upon-Tyne'}, {'name': 'Sharon Erb, Mrs', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Newcastle Upon-Tyne'}, {'name': 'Daniel Weintraub', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Associate Professor of Psychiatry and Neurology, Perelman School of Medicine at the University of Pennsylvania'}, {'name': 'Lynn Rochester', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Professor of Human Movement Science, Institute for Ageing and Health, Newcastle University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Newcastle-upon-Tyne Hospitals NHS Trust', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Newcastle Upon-Tyne', 'class': 'OTHER'}, {'name': 'University of Cambridge', 'class': 'OTHER'}, {'name': 'University of Manchester', 'class': 'OTHER'}, {'name': 'University of Birmingham', 'class': 'OTHER'}, {'name': 'Bangor University', 'class': 'OTHER'}, {'name': 'London School of Economics and Political Science', 'class': 'OTHER'}, {'name': 'University College, London', 'class': 'OTHER'}, {'name': 'Lancashire Care NHS Foundation Trust', 'class': 'NETWORK'}, {'name': 'Newcastle University', 'class': 'OTHER'}, {'name': "King's College London", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}