Condition category
Nervous System Diseases
Date applied
12/06/2013
Date assigned
12/06/2013
Last edited
27/08/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

Acronym

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 we assessed memory before and after PD patients had taken their morning medication. Our 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 our 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 controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient 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 measures

Provide 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

Examine the 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

Eligibility

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

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.

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

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

Sponsor information

Organisation

University Hospital of North Staffordshire (UK)

Sponsor details

RPD City General
New castle road
Stoke-on-Trent
ST4 6QG
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes