Study across 22 UK hospitals investigating if a drug called Donepezil Hydrochloride can help people with an early form of Parkinson's Disease dementia.
- Conditions
- Parkinson's disease with mild dementia (PDD)Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2009-015170-35-GB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 62
1. A diagnosis of Parkinson’s disease (PD) according to UK Parkinson's Disease Society Brain Bank Criteria. These criteria are in standard use throughout the NHS in the UK and are supported by the NICE guidelines.
2. People with mild dementia associated with PD, where the patient and/or their family has become aware of cognitive problem 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 score(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 6 (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 spokesperson.
4. Where relevant, women of child bearing potential must be using adequate contraception for the duration of study.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 0
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 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 (BDI) and a cut-off score of 13/14, 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 or contraindication to donepezil hydrochloride (including a clinically significant cardiac conduction defect).
7. Presence of a condition that is contraindicative to use of donepezil hydrochloride (including a clinically significant cardiac conduction defect found in patient history or from screening ECG)
8. Allergy/hypersensitivity to excipients of donepezil hydrochloride 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method