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Rotigotine and memory in Parkinson's.

Conditions
Idiopathic Parkinson's Disease
Therapeutic 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
Inclusion Criteria

- 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

Exclusion Criteria

- 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
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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