Rotigotine and memory in Parkinson's.
- Conditions
- Idiopathic Parkinson's DiseaseTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2014-000335-17-GB
- Lead Sponsor
- Research and Development University Hospital of North Staffordshire
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 0
- A diagnosis of idiopathic, sporadic Parkinson's (UK-Brain Bank Criteria).
- A Hoehn and Yahr (1967) severity staging of 1-4.
- An established prescription of rotigotine with/without controlled release l-dopa therapy, and with/without a monoamine oxidase-B inhibitor.
or
- An established prescription of controlled release l-dopa therapy, with/without adjuvant monoamine Oxidase-B inhibitor (absence of a dopamine agonist).
- Aged between 50-80 years.
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 21
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 54
- Significant cognitive decline indicated by a score of less than 26 on the Mini- Mental State Examination (MMSE, Foltstein et al, 1975) or by a functional assessment by a clinician during a screening visit.
- Younger than 50 or older than 80.
- A history of hallucinations.
- Other psychiatric or neurological illness (other than Parkinson's).
- Doses of medication that are above maximum recommended dose.
- Women of child bearing potential unless they are using a recognised effective form of contraception or are not sexually active and have no intention of becoming sexually active during the course of the trial.
- Familial Parkinson's Disease.
- Unable to provide informed consent due to cognitive decline.
- Learning difficulties.
- History of alcohol or drug abuse.
- Physical inability to attend or comply with the trial schedule.
- Severe Parkinson's as indicated by a score 5 on the Hoehn and Yahr Disease rating scale.
- English not first language (the recognition memory test uses words that have been standardised within the English language).
- Active malignancy.
- COMT inhibitors, apomorphine, amantadine and anticholinergic therapy. These treatment have been previously shown to impair cognitive performance (such as memory).
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