Donepezil in early dementia associated with Parkinson's disease

Phase 3

Completed

• Conditions: Parkinson's disease with mild dementia; Nervous System Diseases; Parkinson's disease

• Registration Number: ISRCTN30151023
• Lead Sponsor: ewcastle upon Tyne Hospitals NHS Foundation Trust (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-08-07
• Study Completion: 2014-10-31
• Last Update Posted: 1 July 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

1. Aged greater than or equal to 18 years, no upper age limit, either sex
2. A diagnosis of Parkinson's disease according to UK Parkinson's Disease Society Brain Bank Criteria
3. 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). 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 6 (corresponding to between the 6th and 28th percentile) will be used to define mild dementia.
4. Community-living and a spouse, close relative or well established informal carer to accompany the subject to act as an informant
5. 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).
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. This will be operationalised using the self-completed Beck Depression Inventory and a cut-off score of 13/14.
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)
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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. Mattis Dementia Rating Scale (DRS-2)<br> 2. Neuropsychiatric Inventory<br> 3. Bristol Activity of Daily Living Scale<br><br> All primary and secondary outcome measures will be measured at baseline (commencement of treatment), 26 weeks, 52 weeks, 76 weeks and 104 weeks (+/- 7 days for each visit). The primary analysis will focus on outcomes at 104 weeks.<br>

Secondary Outcome Measures

Name	Time	Method
<br> 1. Quality of life via:<br> 1.1. European Quality of Life questionnaire (EQ5D)<br> 1.2. Dementia Quality of Life (DEMQOL)<br> 1.3. DEMQOL-proxy<br> 2. Costs via Client Service Receipt Inventory<br><br> All primary and secondary outcome measures will be measured at baseline (commencement of treatment), 26 weeks, 52 weeks, 76 weeks and 104 weeks (+/- 7 days for each visit). The primary analysis will focus on outcomes at 104 weeks.<br>