EUCTR2012-000801-64-GB进行中（未招募）1 期
A Phase IV Acceptability and Feasibility Trial of the Effects of Medication on Memory in Idiopathic Nondementing Parkinson’s Disease. - Medication and Memory in Parkinson’s Disease (MeMory PaD)
niversity Hospital of North Staffordshire0 个研究点目标入组 55 人开始时间: 2012年11月26日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 55
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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.
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