A phase IV acceptability and feasibility trial of the effects of medication on memory in idiopathic nondementing Parkinson's disease

Phase 4

Completed

• Conditions: Topic: Dementias and Neurodegenerative Diseases Research Network; Subtopic: Parkinson'?s Disease; Disease: Parkinson's disease; Nervous System Diseases; Parkinson disease

• Registration Number: ISRCTN39374171
• Lead Sponsor: niversity Hospital of North Staffordshire (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-06-12
• Study Completion: 2015-02-04
• Last Update Posted: 15 July 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified