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11 February 2012
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| [ Print-friendly version ] |
| A randomized double blind placebo controlled study to evaluate the modulation of cognitive functions in Parkinson's subjects by sildenafil |
| ISRCTN | ISRCTN18044132 |
| ClinicalTrials.gov identifier | |
| Public title | A randomized double blind placebo controlled study to evaluate the modulation of cognitive functions in Parkinson's subjects by sildenafil |
| Scientific title | |
| Acronym | SCOPE |
| Serial number at source | A1481189 |
| Study hypothesis | That 48 weeks of sildenafil therapy will stabilize or slow down the progression of cognitive impairment in Parkinson's disease subjects with mild cognitive impairment when compared with untreated Parkinson's disease controls. The study will also assess the effects of sildenafil upon motor state and olfaction in Parkinson's disease since these parameters may also be improved by sildenafil. |
| Lay summary | |
| Ethics approval | Not provided at time of registration |
| Study design | Randomised controlled trial |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Parkinson's disease (PD) |
| Participants - inclusion criteria |
1. Male or female subjects (excluding women of child bearing potential) between the ages of 50 and 80 years, inclusive
2. Diagnosis of Parkinson's disease according to UK Parkinson's Disease Society Brain Bank Criteria 3. Diagnosis of Parkinson's disease >12 months 4. Mild cognitive impairment insufficient to fulfill Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for dementia, with MMSE score 18-27 5. University of Pennsylvania Smell Identification Test (UPSIT) test score of <30 6. Subjects must be willing and able to provide written informed consent |
| Participants - exclusion criteria |
1. Subjects with evidence of severe or unstable concomitant medical illness
2. Known hypersensitivity to, or current use of sildenafil, or other PDE5 inhibitors 3. Clinically significant orthostatic hypotension (defined as disabling postural light-headedness or syncopal episodes associated with a fall in systolic blood pressure on standing of over 30 mmHg) 4. Patient taking anti-psychotic or cholinesterase inhibitor medication 5. Patient taking dopamine agonists 6. Major depressive disorder 7. Anosmia secondary to head injury/non-PD related cause 8. Exclusion of patients with Multiple Systems Atrophy 9. Exclusion of patients with colour-blindness 10. Subjects who were prescribed and/or are taking nitrates or nitric oxide donors in any form (oral, sub-lingual, tansdermal, inhalation,aerosols), alpha blockers and/or class IA or III anti-arrhythmic medication 11. Use of medication known or suspected to be potent or moderate inhibitors of cytochrome P4503A4 (excluding ketoconazole, itraconazole, cimetidine, ritonavir) 12. Subjects with congenital QT prolongation 13. Electrocardiogram (ECG) evidence of severe life-threatening rhythm or ischaemic disturbances including acute myocardial infarction (within last year), left bundle branch block, or ventricular tachycardia 14. QTcF prolongation >500 msecs 15. Sustained hypertension >170 mmHg systolic or >110 mmHg diastolic; sustained hypotension <90 mmHg systolic or <50 mmHg diastolic 16. History of regular alcohol abuse within 6 months of screening 17. Treatment with investigational drug within 30 days or 5 half-lives (whichever is longer) preceding the first dose of study medication |
| Anticipated start date | 14/12/2004 |
| Anticipated end date | 30/09/2006 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 100 subjects, 50 randomised to both sildenafil and placebo group |
| Interventions | Sildenafil dosing in the treatment group will start at 50 mg once daily for 4 weeks. Dosing is then increased to 100 mg daily for a further 44 weeks. The control group will receive matching placebo teatment for 48 weeks. |
| Primary outcome measure(s) |
1. To test if 48 weeks of sildenafil therapy will result in improved cognitive functions in Parkinson's disease subjects as measured by the paired association learning (PAL) test
2. To test if 48 weeks of sildenafil therapy will result in improved olfaction in Parkinson's disease subjects as measured by the UPSIT test |
| Secondary outcome measure(s) | To test if 48 weeks of sildenafil therapy will result in improved motor and cognitive function in Parkinson's disease subjects as measured by the Unified Parkinson's Disease Rating Scale (UPDRS), Dyskinesia Rating Scale, Spatial Working Memory Test and Reaction Time Test. |
| Sources of funding | Study is fully funded by Pfizer Inc. (USA) |
| Trial website | |
| Publications | |
| Contact name | Dr David Burn |
| Address |
Regional Neurosciences Centre
Newcastle General Hospital Westgate Road |
| City/town | Newcastle |
| Zip/Postcode | NE46BE |
| Country | United Kingdom |
| Tel | +44 (0)1912563425 |
| Fax | +44 (0)1912727242 |
| d.j.burn@ncl.ac.uk | |
| Sponsor | Pfizer Inc. (USA) |
| Address |
Groton Laboratories
Clinical Sciences Dept. 445 Eastern Point Road |
| City/town | Groton |
| Zip/Postcode | CT06340 |
| Country | United States of America |
| Date applied | 30/08/2005 |
| Last edited | 14/09/2009 |
| Date ISRCTN assigned | 26/09/2005 |
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| © 2012 ISRCTN unless otherwise stated. | |
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