ISRCTN39374171已完成4 期
A phase IV acceptability and feasibility trial of the effects of medication on memory in idiopathic nondementing Parkinson's disease
niversity Hospital of North Staffordshire (UK)0 个研究点目标入组 22 人开始时间: 2013年6月12日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 22
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Demographic characteristics:
- •1. Males and females
- •2. Aged between 50-80 years
- •Medical condition:
- •1. 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
- •2. Capacity to provide fully informed signed consent
- •Indicated treatments:
- •1. Currently medicated with slow release preparations of either pramipexole ER or ropinirole XL
- •2. Adjuvant therapy with ldopa and/or a monoamine oxidase B inhibitor (such as rasagiline/AZILECT or selegiline/ ELDEPRYL, ZELAPAR)
- •Target Gender: Male & Female; Upper Age Limit 80 years ; Lower Age Limit 50 years
排除标准
- •Demographic characteristics:
- •1. Patient-participants younger than 50 and older than 80 years of age
- •2. English is a second language
- •Medical, psychiatric, developmental conditions:
- •1. Cognitive impairment as assessed with the Mini-Mental State Examination scoring of 25 or less
- •2. Familial Parkinson'?s disease
- •3. Severe Parkinson?'s disease, indicated by a score of 5 on the Hoehn and Yahr disease severity rating scale
- •4. Unable to provide informed consent due to cognitive decline
- •5. Comorbid for another neurological illness (other than Parkinson?s disease)
- •6. History of learning difficulty including dyslexia
- •7. Physical inability to attend or comply with treatment scheduling, such as upper limb amputations, Crippling degenerative arthritis
- •8. Current or planned participation in another clinical trial or study
- •9. Active malignancy
- •10. Pre-planned or elective surgeries during the period of involvement in the trial
- •11. Prior or current history (within the previous 5 years) of significant and/or uncontrolled drug abuse or alcoholism
- •12. Major psychotic phenomenology including hallucinations or lack of awareness of dyskinesias
- •13. Hypotension: severe dizziness or fainting on standing
- •14. Impulse control disorders or compulsive behaviours
- •15. Incapacitating dyskinesias on a stable dose of ldopa
- •16. Hepatic impairment
- •17. Severe renal impairment (creatinine clearance < 50 ml/min)
- •18. eGFR of less than 50 ml/min/1.73m(squared)
- •19. Women of child bearing potential unless they are using a recognized, effective form of contraception or they are not sexually active and have no intention of becoming sexually active during the duration of their involvement in the trial
- •20. Contraindicated treatments
- •21. Patient-participants taking any of the following drugs:
- •21.1. COMT inhibitors (entacapone/COMTAN or tocapone/TASMAR)
- •21.2. Apomorphine
- •21.3. Amantadine (population pharmacokinetic analyses suggest that amantadine may slightly decrease the oral clearance of pramipexole)
- •21.4. Anticholinergics
- •21.5. Dopamine antagonists (phenothiazines, butyrophenones, thioxanthenes) or metoclopramide, ciprofloxacin
- •21.6. Immediate-release preparations of either pramipexole or ropinirole
- •22. Patient- participants treated with deep brain stimulation
研究者
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