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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	16 December 2017
Main ID:	NCT01014858
Date of registration:	16/11/2009
Prospective Registration:	Yes
Primary sponsor:	Newcastle-upon-Tyne Hospitals NHS Trust
Public title:	Multi-centre UK Study of the Acetylcholinesterase Inhibitor Donepezil in Early Dementia Associated With Parkinson's Disease MUSTARDD-PD
Scientific title:	Multi-centre UK Study of the Acetylcholinesterase Inhibitor Donepezil in Early Dementia Associated With Parkinson's Disease
Date of first enrolment:	January 2013
Target sample size:	64
Recruitment status:	Terminated
URL:	https://clinicaltrials.gov/show/NCT01014858
Study type:	Interventional
Study design:	Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
Phase:	Phase 3

Countries of recruitment
United Kingdom

Contacts

Name:	Roger A Barker, Dr
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Affiliation:	Cambridge University

Name:	Elaine McColl, Professor
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Affiliation:	University of Newcastle Upon-Tyne

Name:	Andrew J Lees, Professor
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Affiliation:	University College, London

Name:	Iracema Leroi, DR
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Affiliation:	Lancashire Care Trust, Royal Blackburn Hospital

Name:	John V Hindle, Dr
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Affiliation:	Llandudno Hospital & University of College Wales

Name:	John T O'Brien, Professor
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Affiliation:	Newcastle University

Name:	Lynn Rochester
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Affiliation:	Professor of Human Movement Science, Institute for Ageing and Health, Newcastle University

Name:	Ian N Steen, Dr
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Affiliation:	University of Newcastle Upon-Tyne

Name:	Jennifer Wilkinson, Mrs
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Affiliation:	University of Newcastle Upon-Tyne

Name:	Keith Wheatley, Professor
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Affiliation:	Cancer Research UK Clinical Trials Unit, School of Cancer Sciences, University of Birmingham

Name:	Alistair Burns, Professor
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Affiliation:	School of Community Based Medicine, University of Manchester

Name:	Sharon Erb, Mrs
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Affiliation:	University of Newcastle Upon-Tyne

Name:	Daniel Weintraub
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Affiliation:	Associate Professor of Psychiatry and Neurology, Perelman School of Medicine at the University of Pennsylvania

Name:	Martin Knapp, Professor
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Affiliation:	London School of Economics and Political Science

Name:	David J Burn, Professor
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Affiliation:	Newcastle University

Name:	Carl E Clarke, Professor
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Affiliation:	Clarke

Name:	Belinda Braithwaite, Mrs
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Affiliation:	lay person

Name:	Ian G McKeith, Professor
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Affiliation:	Newcastle University

Key inclusion & exclusion criteria

Inclusion Criteria:

1. 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.

2. 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".

3. Community-living and a spouse, close relative or well established carer to accompany
the subject to act as an informant.

4. Where relevant, women of child bearing potential must be using adequate contraception
for duration of study.

Exclusion Criteria:

1. 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.

2. 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.

3. 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.

4. Unstable significant medical co-morbidity.

5. Patient receiving an anticholinergic drug for control of parkinsonian motor symptoms.

6. Previous exposure to a cholinesterase inhibitor

7. 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.

8. Allergy/hypersensitivity to excipients of donepezil or placebo

9. Patient receiving the N-methyl-d-aspartate antagonist memantine.

10. 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.

Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Parkinson's Disease

Intervention(s)

Drug: Donepezil

Primary Outcome(s)

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. [Time Frame: After 24 month of treatment]

Secondary Outcome(s)

To demonstrate the superiority of donepezil over placebo in improving patient and carer quality of life and to establish the cost-effectiveness of donepezil. [Time Frame: 26, 52 and 104 weeks]

Secondary ID(s)

08/13/14

5137

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

University of Birmingham

Lancashire Care NHS Foundation Trust

University College, London

London School of Economics and Political Science

University of Cambridge

Bangor University

King's College London

Newcastle University

University of Manchester

University of Newcastle Upon-Tyne

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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