A phase IV acceptability and feasibility trial of the effects of medication on memory in idiopathic nondementing Parkinson's disease
| ISRCTN | ISRCTN39374171 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN39374171 |
| EudraCT/CTIS number | 2012-000801-64 |
| Secondary identifying numbers | 13793 |
- Submission date
- 12/06/2013
- Registration date
- 12/06/2013
- Last edited
- 21/06/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Ms Sharon Hurlestone
Scientific
Scientific
Neurology Research Unit
Newcastle Road
Stoke-On-Trent
ST4 6QG
United Kingdom
| Sharon.Hurlstone@uhns.nhs.u |
Study information
| Study design | Non-randomised; Interventional; Design type: Treatment |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | A phase IV acceptability and feasibility trial of the effects of medication on memory in idiopathic nondementing Parkinson's disease |
| Study acronym | MeMory PaD |
| Study objectives | An estimated 122,795 people aged 65+ in the UK have Parkinson's disease (PD). Its a progressive illness caused by the loss of a brain chemical called dopamine which results in tremor, slowed movement and difficulty initiating voluntary movements. Dopamine restoring drugs provide respite from these symptoms with slow-release dopamine agonists (ropinirole hydrochloride prolonged release and pramipexole dihydrochloride monohydrate prolonged release) being the mainstay of treatment. PD patients also report memory decline, the severity of which is reduced when they wake up in the morning before they take their dopamine-replacement medication as compared to the rest of the day implying that the same medication which offers relief from movement problems simultaneously impairs memory. In a series of studies memory was assessed before and after PD patients had taken their morning medication. The findings showed a significant decline in memory when patients were medicated compared to un-medicated. This effect was particularly marked for patients on dopamine agonists (ropinirole hydrochloride prolonged release and pramipexole dihydrochloride monohydrate prolonged release) compared to a different class of dopamine-restoring medication (i.e. l-dopa).These findings are important because patients are not seeking help for their memory decline and clinicians are not providing advice to patients about this or considering memory decline when making treatment choices. The over-arching aim of this research programme is to release a set of guidelines of the causes and management of drug-dependent memory decline for clinicians (target 2017) with the purpose of increasing general awareness of memory decline in PD. This feasibility trial represents the 1st stage in this programme, its purpose to gather info about a series of process outcomes such as drop-out rate and to identify barriers to participation, all of which will feed into a larger multi-centre randomised controlled trial. |
| Ethics approval(s) | 13/NW/0009 |
| Health condition(s) or problem(s) studied | Topic: Dementias and Neurodegenerative Diseases Research Network; Subtopic: Parkinson's Disease; Disease: Parkinson's disease |
| Intervention | Cross over trial. In arm 1, patients-participants start on pramipexole and then switch to ropinirole. In arm 2, they start on ropinirole and are then switched to pramipexole. Patient-participants are stabilised on each medication for 6 weeks before having their memory assessed twice when in a medicated state and following a period of medication withdrawal (termed ON and OFF state) |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase IV |
| Drug / device / biological / vaccine name(s) | Pramipexole, Ropinirole |
| Primary outcome measure | Estimates of memory performance which will inform a power calculation for a large RCT; Timepoint(s): Baseline, 2 memory assessments : mid study and end of study |
| Secondary outcome measures | Efficacy of processes and procedures used during the medication withdrawal process; Timepoint(s): mid study, end of study |
| Overall study start date | 04/02/2013 |
| Completion date | 04/02/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | Planned Sample Size: 50; UK Sample Size: 50; Description: 50 patients to complete the study |
| Total final enrolment | 22 |
| Key inclusion criteria | Demographic characteristics: 1. Males and females 2. Aged between 50-80 years Medical condition: 1. Idiopathic, sporadic Parkinsons disease, diagnosed by as determined by the UK Parkinsons Disease Society Brain Bank Clinical Diagnostic Criteria (1992) Parkinsons 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 |
| Key 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 Parkinsons 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 |
| Date of first enrolment | 04/02/2013 |
| Date of final enrolment | 04/02/2015 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Neurology Research Unit
Stoke-On-Trent
ST4 6QG
United Kingdom
ST4 6QG
United Kingdom
Sponsor information
University Hospital of North Staffordshire (UK)
Hospital/treatment centre
Hospital/treatment centre
RPD City General
New castle road
Stoke-on-Trent
ST4 6QG
England
United Kingdom
Funders
Funder type
Government
National Institute for Health Research - Research for Patient Benefit (RfPB); Grant Codes: PB-PG-0211-24101
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | 21/06/2019 | No | No | ||
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
21/06/2019: Added clinicaltrialsregister.eu link to basic results (scientific). Added total final enrollment.
12/01/2017: No publications found, verifying study status with principal investigator.
