Multi-centre UK Study of the Acetylcholinesterase Inhibitor Donepezil in Early Dementia Associated With Parkinson's Disease (MUSTARDD-PD)

This study has suspended participant recruitment.
(Due to low recruitment)
Sponsor:
Collaborators:
University of Newcastle Upon-Tyne
University of Cambridge
University of Manchester
University of Birmingham
Bangor University
London School of Economics and Political Science
University College, London
Lancashire Care Trust
Newcastle University
King's College London
Information provided by (Responsible Party):
Sharon Erb, Newcastle-upon-Tyne Hospitals NHS Trust
ClinicalTrials.gov Identifier:
NCT01014858
First received: November 16, 2009
Last updated: June 20, 2014
Last verified: June 2014

November 16, 2009
June 20, 2014
January 2013
May 2017   (final data collection date for primary outcome 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. [ Time Frame: After 24 month of treatment ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01014858 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Multi-centre UK Study of the Acetylcholinesterase Inhibitor Donepezil in Early Dementia Associated With Parkinson's Disease
Multi-centre UK Study of the Acetylcholinesterase Inhibitor Donepezil in Early Dementia Associated With Parkinson's Disease

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.

To demonstrate the superiority of donepezil over placebo in improving patient and carer quality of life and to establish the cost-effectiveness of donepezil.

To determine the instrument most suitable for evaluating change in cognition in people with Parkinson's disease and mild dementia.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Parkinson's Disease
Drug: Donepezil
5mg donepezil daily for first 8 weeks and then increased to 10mg daily for the remainder of the study.
  • Experimental: Donepezil
    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.
    Intervention: Drug: Donepezil
  • Placebo Comparator: Placebo
    Patient commences medication to match appearance of 5mg donepezil for first 8 weeks then 10mg for the remainder of the study.
    Intervention: Drug: Donepezil
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Suspended
500
May 2017
May 2017   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01014858
5137, 08/13/14
Yes
Sharon Erb, Newcastle-upon-Tyne Hospitals NHS Trust
Sharon Erb
  • University of Newcastle Upon-Tyne
  • University of Cambridge
  • University of Manchester
  • University of Birmingham
  • Bangor University
  • London School of Economics and Political Science
  • University College, London
  • Lancashire Care Trust
  • Newcastle University
  • King's College London
Study Chair: David J Burn, Professor Newcastle University
Study Director: Roger A Barker, Dr Cambridge University
Study Director: Belinda Braithwaite, Mrs lay person
Study Director: Alistair Burns, Professor School of Community Based Medicine, University of Manchester
Study Director: Carl E Clarke, Professor Clarke
Study Director: Elaine McColl, Professor University of Newcastle Upon-Tyne
Study Director: John V Hindle, Dr Llandudno Hospital & University of College Wales
Study Director: Martin Knapp, Professor London School of Economics and Political Science
Study Director: Andrew J Lees, Professor University College, London
Study Director: Iracema Leroi, DR Lancashire Care Trust, Royal Blackburn Hospital
Study Director: Ian G McKeith, Professor Newcastle University
Study Director: John T O'Brien, Professor Newcastle University
Study Director: Keith Wheatley, Professor Cancer Research UK Clinical Trials Unit, School of Cancer Sciences, University of Birmingham
Study Director: Ian N Steen, Dr University of Newcastle Upon-Tyne
Study Director: Jennifer Wilkinson, Mrs University of Newcastle Upon-Tyne
Study Director: Sharon Erb, Mrs University of Newcastle Upon-Tyne
Study Director: Daniel Weintraub Associate Professor of Psychiatry and Neurology, Perelman School of Medicine at the University of Pennsylvania
Study Director: Lynn Rochester Professor of Human Movement Science, Institute for Ageing and Health, Newcastle University
Newcastle-upon-Tyne Hospitals NHS Trust
June 2014

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