A study of the effects of medication on memory in Parkinson's Disease

Phase 1

• Conditions: Idiopathic Parkinson's Disease; MedDRA version: 17.0Level: LLTClassification code 10013113Term: Disease Parkinson'sSystem Organ Class: 100000004852; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2012-000801-64-GB
• Lead Sponsor: niversity Hospital of North Staffordshire

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11-26
• Last Update Posted: 19 November 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 55

Inclusion Criteria

Demographic characteristics

•Males and females.
•Aged between 50-80 years.

Medical condition

•Idiopathic, sporadic Parkinson’s disease, diagnosed by as determined by the UK Parkinson’s Disease Society Brain Bank Clinical Diagnostic Criteria (1992).
•Parkinson’s disease stages, mild: 1, 2, 2.5; or moderate: 3 and 4, as determined by the modified Hoehn-Yahr (HY) disease severity rating scale.
•Capacity to provide fully informed signed consent.

Indicated treatments:

•Currently medicated with either Pramipexole modified release (Mirapexin® Prolonged Release) 520 micrograms to 3.15mg or Ropinirole modified release (Requip® XL) range 2mg to 12mg.
•Maybe receiving adjuvant therapy with l-dopa and / or a monoamine oxidase B inhibitor (such as rasagiline/AZILECT or selegiline/ ELDEPRYL, ZELAPAR).

*Note Patients who are not receiving adjuvant therapy will also meet the inclusion criteria.

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 16
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 34

Exclusion Criteria

All doses of IMP that fall outside of the inclusion criteria

Demographic Characteristics:
- Patient-participant-participants younger than 50 and over 80 years of age;
- English is a second language.

Medical, Psychiatric, Developmental Conditions:
Renal impairment (creatinine clearance <50ml/min or eGFR less than 50 ml/minute/1.73m2)Severe hepatic impairment (liver function tests: ALT, Total Bilirubin, Albumin Alk phos/ALP; GGT may also be assessed– depending on the Alk level - 3 times upper limit of normal range)
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;
Cognitive impairment as assessed with the Mini-Mental State Examination scoring 25 or less;
Severe PD, indicated by a score of 5 on the Hoehn and Yahr disease severity rating scale;
- Unable to provide informed consent due to cognitive decline;
- Co-morbid for another neurological illness (other than PD);
- History of learning difficulty including dyslexia;
- Physical inability to attend or comply with treatment scheduling, such as upper limb amputations, crippling degenerative arthritis;
- Current or planned participation in another drug trial;
- Active malignancy;
- Family history of PD;
-Patient or family history of allergic reaction to either ropinirole or pramipexole
- Drug abuse or alcoholism;
- Major psychotic phenomenology including hallucinations or lack of awareness of dyskinesias;
- Hypotension;
- Severe dizziness or fainting on standing;
- Impulse control disorders or compulsive behaviours;
- Incapacitating dyskinesias on a stable dose of l-dopa;
- pre-planned or elective surgeries during the period of involvement in the trial.

Contraindicated Medication and Treatments:
COMT inhibitors; apomorphine; amantadine; anticholinergics; dopamine antagonists; ciprofloxacin; immediate-release preparations of either pramipexole dihydrochloride monohydrate or ropinirole hydrochloride; deep brain stimulation.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified