Parkinson's disease Nervous System Diseases Parkinson's disease
Conditions
Interventions
The protocol includes several experiments investigating different drugs and patient groups, however for the purpose of ISRCTN registration we describe one experiment using the drug atomoxetine.
on that day they undergo the scan which takes 60 minutes, as well as standardised cognitive screening tests and a standardised assessment of clinical motor and non-motor symptoms.
Sponsors
Cambridge University Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Idiopathic Parkinson’s disease 2. Hoehn and Yahr stage 1.5–3 3. Age 45 - 80 years 4. English speaking
Exclusion criteria
Exclusion criteria: 1. Dementia (MMSE 25 or less) 2. Clinically significant current depression 3. Contraindications to MRI 4. Contraindication to atomoxetine, including: 4.1 Ischemic heart disease or cardiac rhythm abnormalities 4.2 other significant non-ischemic cardiac disease 4.3 uncontrolled hypertension 4.4 adverse drug reactions to closely related drugs 4.5 major psychiatric disorders including mania or schizophrenia 4.6 epilepsy 4.7 warfarin/monoamine oxidase inhibitor 4.8 known hepatic or renal failure
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Measured 2 hours after taking drug/placebo: 1. Response inhibition measured using a stop-signal task and operationalised by the stop-signal reaction time (SSRT) 2. Learning performance measured using a computerised reinforcement learning task 3. Effort-based motivation measured using a computerised force production task 4. Physiological measures measured using a 3-channel electrocardiogram (ECG) to measure heart rate, and an eye tracker to measure oculomotor function and pupil diameter | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Locus coeruleus integrity measured using magnetisation transfer weighted magnetic resonance imaging (MRI) scans. This scan will be part of a battery of scans including MRPAGE, resting BOLD-sensitive echo-planar imaging and T2. The scans are conducted on a separate day within 3 months of the drug/placebo sessions 2. General background data on the distribution and severity of clinical features, cognitive deficits and behavioural changes. Assessed using a battery of standardised questionnaires completed by the patient and an informant, and cognitive screening tests, completed within 2 weeks of the drug/placebo sessions. These measures are taken once and the battery includes: 2.1. Addenbrooke’s Cognitive Examination - revised (ACE-r) 2.2. Mini-mental state examination (MMSE), 2.3. Montreal cognitive assessment (MoCA) 2.4. Movement Disorders Society Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) 2.5. Hospital Anxiety and Depression scale (HADS) 2.6. Cambridge Questionnaire for Apathy and Impulsivity (CAM-QUAIT) 2.7. Cambridge Behavioural Inventory (CBI) 2.8. Barratt Impulsiveness Scale (BIS-11) 2.9. Conners’ Adult ADHD Rating Scale (CAARS) 2.10. Apathy Scale 2.11. Motivation and Energy Inventory (MEI) 2.12. REM sleep behaviour disorder screening questionnaire (RBDSQ) 3. Wellbeing, alertness and fatigue-related symptoms assessed using a Visual Analogue Scale completed before the drug/placebo and after the 2 hour wait time following drug administration, i.e. twice a day on study days | — |
Countries
United Kingdom
Contacts
Public ContactClaire O'Callaghan
Outcome results
None listed