Contact information
Type
Scientific
Primary contact
Ms Sharon Hurlestone
ORCID ID
Contact details
Neurology Research Unit
Newcastle Road
Stoke-On-Trent
ST4 6QG
United Kingdom
-
Sharon.Hurlstone@uhns.nhs.u
Additional identifiers
EudraCT number
2012-000801-64
ClinicalTrials.gov number
Protocol/serial number
13793
Study information
Scientific title
A phase IV acceptability and feasibility trial of the effects of medication on memory in idiopathic nondementing Parkinson's disease
Acronym
MeMory PaD
Study hypothesis
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
13/NW/0009
Study design
Non-randomised; Interventional; Design type: Treatment
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
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
Phase
Phase IV
Drug names
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 trial start date
04/02/2013
Overall trial end date
04/02/2015
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Senior
Gender
Both
Target number of participants
Planned Sample Size: 50; UK Sample Size: 50; Description: 50 patients to complete the study
Total final enrolment
22
Participant 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
Recruitment start date
04/02/2013
Recruitment end date
04/02/2015
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Neurology Research Unit
Stoke-On-Trent
ST4 6QG
United Kingdom
Funders
Funder type
Government
Funder name
National Institute for Health Research - Research for Patient Benefit (RfPB); Grant Codes: PB-PG-0211-24101
Alternative name(s)
NIHR
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
See: https://www.clinicaltrialsregister.eu/ctr-search/trial/2012-000801-64/results (added 21/06/2019)
Publication list