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| ID | Type | Description | Link |
|---|---|---|---|
| 2007-004400-12 |
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The purpose of this study is to determine whether rasagiline is effective in the treatment of apathy in patients with Parkinson's disease.
The primary objective of this study is to evaluate the efficacy of rasagiline in patients with Parkinson's disease (PD) and apathy. Secondary objectives are 1) to evaluate the affective and cognitive response to rasagiline and their correlates to apathy and 2) to investigate the metabolic and neurophysiologic correlates of the behavioural, cognitive and emotional, aspects of apathy in PD. This will be an exploratory, randomized, double-blind, placebo controlled, parallel-group study. 40 PD patients with apathy and without dementia will be recruited. Rasagiline 1 mg or matching placebo will be administered once daily in conjunction with the subjects' usual oral antiparkinsonian medications for up to 12 weeks. Patients will be evaluated at screening (-7 days) and baseline (0), as well as at weeks 4, 8, and 12. A perfusion SPECT will be performed at baseline and at week 12. The study will be conducted at the Movement Disorders Unit of the Neurology Department at Sant Pau Hospital (Barcelona, Spain).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rasagiline | Drug | rasagiline 1 mg daily, oral use, during 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| The primary outcome measure will be the mean change from baseline to study endpoint (week 12) in apathy scores as measured by the Lille Apathy Rating Scale (LARS)and the Apathy Scale | week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary outcome measures will include change from baseline to study endpoint on a range of scales assessing apathy, depression, other neuropsychiatric symptoms, cognition, sleepiness and quality of life | week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jaime Kulisevsky, MD,PhD | Neurology Service at Hospital de la Santa Creu i Sant Pau, Autonomous University of Barcelona (Barcelona, Spain) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fundacio de Gestio Sanitaria de l'Hospital de la Santa Creu i Sant Pau | Barcelona | Barcelona | 08025 | Spain |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D053609 | Lethargy |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| C031967 | rasagiline |
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| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |