Simvastatin as a Neuroprotective Treatment for Moderate Parkinson's Disease (PD STAT)
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|ClinicalTrials.gov Identifier: NCT02787590|
Recruitment Status : Active, not recruiting
First Posted : June 1, 2016
Last Update Posted : June 1, 2020
|Condition or disease||Intervention/treatment||Phase|
|Parkinson Disease||Drug: Simvastatin Drug: Matched Placebo (for Simvastatin)||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||235 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Simvastatin as a Neuroprotective Treatment for Parkinson's Disease: a Double-blind, Randomised, Placebo Controlled Futility Study in Patients of Moderate Severity.|
|Actual Study Start Date :||March 21, 2016|
|Estimated Primary Completion Date :||June 2020|
|Estimated Study Completion Date :||August 2020|
Active Comparator: Simvastatin
A one month low dose phase of 40mg oral simvastatin daily will be followed by a 23 month high dose phase of 80mg oral simvastatin daily and a final two month phase off trial medication
Placebo Comparator: Matched Placebo
A one month low dose phase of 40mg matched placebo daily will be followed by a 23 month high dose phase of 80mg matched placebo daily and a final two month phase off trial medication
Drug: Matched Placebo (for Simvastatin)
- Change in MDS-UPDRS part III (OFF) score [ Time Frame: Baseline and 24 Months ]The MDS-UPDRS is the standard validated tool for the assessment of patients with Parkinson's Disease. This scale includes subsections collecting data regarding the impact of PD on a patient's mood and mental state, (UPDRS part I), their activities of daily living (UPDRS part II) an examination of the motor features of PD (UPDRS part III), and complications arising from the use of dopamine replacement (part IV).
- MDS-UPDRS total score in the practically defined ON state [ Time Frame: at 12 and 24 months ]
- MDS-UPDRS part II subscale score in the practically defined ON state [ Time Frame: at 12 and 24 months ]
- Timed motor tests - finger tapping and timed walk test (10MWT) in the OFF state, electromagnetic sensor (EMS) assessment in the OFF and ON state [ Time Frame: at 12 and 24 months ]Timed Motor Tests include evaluating the number of hand taps (key strokes) that an individual can perform within 30 seconds and a timed walk test (10MWT). Electromagnetic Sensor Measurements include wearing sensors on the index finger and thumb whilst performing 4 MDS-UPDRS items.
- Montgomery and Asberg Depression Rating Scale (MADRS) [ Time Frame: at 12 and 24 months ]The Montgomery and Asberg Depression Rating Scale (MADRS) is a 10 item physician rated depression severity scale previously used in the assessment of PD
- The Addenbrooke's Cognitive Assessment-III (ACE-III) [ Time Frame: at 12 and 24 months ]The Addenbrooke's Cognitive Examination-III (ACE) is one of the most popular and PD STAT protocol version 2.2, 03 March 2016 EudraCT 2015-000148-40 ISRCTN16108482. REC Ref:15/NE/0324 Page 39 of 43 commonly used cognitive tests used in dementia clinics and in the assessment of other neurological disorders. ACE-III includes five subdomains which provide a cognitive score out of a maximum of 100
- Non-Motor Symptom assessment scale (NMSS) [ Time Frame: at 12 and 24 months ]The Non-Motor Symptom assessment scale (NMSS) is a rating scale designed to capture the presence of the non-motor features of PD
- Parkinson's disease Questionnaire (PDQ-39) [ Time Frame: at 12 and 24 months ]The PDQ39 is a PD-specific health status questionnaire used both clinically and within research since its publication in 1995. It consists of 39 items covering eight discrete dimensions: mobility, emotional well-being, stigma, social support, cognition, communication and bodily discomfort. The scores from each dimension are computed into a scale ranging from 0 (best, i.e. no problem at all) to 100 (worst, i.e. maximum level of problem). In addition a summary score, the PDQ-39SI (summary index) can be calculated by averaging the scores of the eight dimensions.
- Changes in PD medication as measured by levodopa-equivalent dose (LED) [ Time Frame: at 12 and 24 months ]
- Cholesterol levels (total, HDL, total/HDL ratio) [ Time Frame: at 12 and 24 months ]
- King's PD pain scale (KPPS) [ Time Frame: at 12 and 24 months ]The King's PD Pain Scale is a PD-specific scale consisting of 14 items within seven domains. Each item is scored by severity (0-3) multiplied by frequency (0-4), resulting in an item sub-score of 0-12 and a total possible score of 0-168.
- EuroQoL 5D-5L health status questionnaire (EQ-5D-5L) [ Time Frame: at 12 and 24 months ]
- Safety and tolerability of trial medication by adverse events (AEs) review. [ Time Frame: at 12 and 24 months ]
- Incidence of diabetes mellitus, using a glycated haemoglobin (HbA1c) level of 6.5% (48mmol/mol) as diagnostic of diabetes mellitus. [ Time Frame: at 24 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02787590
|Study Director:||Camille B Carroll, BM BCh, PhD||Clinical Lecturer (University of Plymouth) and Honorary Consultant Neurologist, Plymouth Hospitals NHS Trust.|