Subjects will be recruited from the Movement Disorders Outpatient Clinics from academic and hospital institutions in Italy. Only subjects with a BDI-IA score > or = 15 at baseline will be enrolled.Subjects have to be under stable treatment with dopaminergic agents at least 4 weeks before baseline. MedDRA version: 9.1 Level: LLT Classification code 10013113
Conditions
Interventions
Trade Name: AZILECT
Pharmaceutical Form: Tablet
INN or Proposed INN: Rasagiline
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1-
Pharmaceutical form of the placeb
Sponsors
LUNDBECK ITALIA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Outpatient, male or female aged ≥ 40 and =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Motor complications such as wearing off and on-off phenomena 2. Mini-Mental State Examination (MMSE) 3 times the upper limit of normal (ULN) 22. Is a member of the site personnel or their immediate families 23. Is under forced treatment 24. Is in current treatment or was previously treated with rasagiline 25. Has previously participated in a rasagiline study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate if rasagiline compared to placebo improves depressive symptoms as evaluated by the Beck Depression Inventory (BDI-IA) total score over a treatment period of 12 weeks.;Secondary Objective: 1. To evaluate if rasagiline compared to placebo improves cognitive function, over a treatment period of 12 weeks, in idiopathic Parkinsons disease (PD) subjects. Cognition will be assessed by the use of a formal neuropsychiatric cognitive test battery: Noun and Verb Naming Tasks (ENPA), Trail Making Test (Trails A & B), Cognitive Performance Test (CPT), Stroop Test (ST), Clock Drawing Test (CDT), Rey Auditory Verbal Learning Test (RAVLT), Benton Judgment of Line Orientation Test (BJLOT), and ReyOsterrieth Complex Figure (ROCF). 2. To evaluate change in quality of life (QOL) following a treatment period of 12 weeks by using the Parkinson`s Disease Questionnaire (PDQ-39) scale. 3. To evaluate change in apathy following a treatment period of 12 weeks by using the Apathy Scale (AS). 4. To evaluate change in activities of daily living (ADL) and motor function following a treatment period of 12 weeks by using the Unified Parkinsons Disease Rating Scale (UPDRS) scales part II a;Primary end point(s): The primary efficacy variable will be the change from baseline in BDI-IA total score. | — |
Countries
Italy
Outcome results
None listed