Condition category
Nervous System Diseases
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Ms Sharon Hurlestone


Contact details

Neurology Research Unit
Newcastle Road
United Kingdom

Additional identifiers

EudraCT number

2012-000801-64 number

Protocol/serial number


Study information

Scientific title

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


MeMory PaD

Study hypothesis

An estimated 122,795 people aged 65+ in the UK have Parkinson's disease (PD). It’s 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


Study design

Non-randomised; Interventional; Design type: Treatment

Primary study design


Secondary study design

Non randomised study

Trial setting


Trial type


Patient information sheet

Not available in web format, please use contact details to request a participant information sheet


Topic: Dementias and Neurodegenerative Diseases Research Network; Subtopic: Parkinson'’s Disease; Disease: Parkinson's disease


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



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


Overall trial end date


Reason abandoned (if study stopped)


Participant 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

Participant type


Age group




Target number of participants

Planned Sample Size: 50; UK Sample Size: 50; Description: 50 patients to complete the study

Total final enrolment


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 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

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Neurology Research Unit
United Kingdom

Sponsor information


University Hospital of North Staffordshire (UK)

Sponsor details

RPD City General
New castle road
United Kingdom

Sponsor type

Hospital/treatment centre



Funder type


Funder name

National Institute for Health Research - Research for Patient Benefit (RfPB); Grant Codes: PB-PG-0211-24101

Alternative name(s)


Funding Body Type

government organisation

Funding Body Subtype

National government


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: (added 21/06/2019)

Publication list

Publication citations

Additional files

Editorial Notes

21/06/2019: Added link to basic results (scientific). Added total final enrollment. 12/01/2017: No publications found, verifying study status with principal investigator.