Emotion, Mood and Executive Function in Parkinson's Disease (PD) (RasQ)
Primary Purpose
Parkinson Disease
Status
Unknown status
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Rasagiline
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease focused on measuring Parkinson Disease, Emotion, mood, executive function
Eligibility Criteria
Inclusion Criteria:
- idiopathic PD
- age range 30-75 yrs, HY I-III
- stable medication for at least 4 weeks prior to baseline
- Native speakers (German)
- signing of informed consent form
Exclusion Criteria:
- clinically significant depression (BDI>13)
- freezing, pronounced fluctuations
- other neurological or psychiatric disorders
- dementia (MMSE<25)
- treatment with the MAO-B-inhibitor Selegiline, antidepressants
- any contraindication according to SmPC
- participation in another interventional study
Sites / Locations
- St. Josef Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Placebo
Rasagiline
Arm Description
Placebo 1 Tbl per day, 12 week (84 days) duration
Azilect Group: Dose: 1 mg per day, 12 week (84 days) duration
Outcomes
Primary Outcome Measures
Assess the effect of Azilect on mood, recognition of facial and vocal affect and emotional expressiveness
Discrimination Faces
Discrimination Affect
Affect Naming -Faces
Discrimination linguistic prosody
Discrimination affective prosody
Affect naming -congruent and incongruent affective prosody Visual Analogue Scales of emotional expressiveness
Rating by study physician and relative
Self-rating by patient Assessment of executive function
Working Memory (n-back task, digit backward)
Verbal Fluency (Regensburger Wortflüssigkeitstest) Beck Depression Inventary (BDI) Apathie Evaluations-Skala (AES) Social Activity Scale - self assessment PDQ-39- self-assessment
Secondary Outcome Measures
Effect on motor function in PD
Unified Parkinson's Disease Rating Scale
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01385735
Brief Title
Emotion, Mood and Executive Function in Parkinson's Disease (PD)
Acronym
RasQ
Official Title
Effects of Azilect (Rasagiline) on Processing of Emotions, Mood and Executive Function in Parkinson's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
June 2011
Overall Recruitment Status
Unknown status
Study Start Date
October 2011 (undefined)
Primary Completion Date
October 2012 (Anticipated)
Study Completion Date
April 2013 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
St. Josef Hospital Bochum
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The current study aims to assess the effect of an 8 week Azilect treatment (as adjunct therapy to levodopa) on affect perception and emotional expressiveness in a double-blind placebo-controlled study.
Detailed Description
Parkinson's disease (PD) is associated with a range of cognitive impairments, most notably deficits of higher order cognitive control mechanisms referred to as "executive dysfunction". These problems have consistently been related to dysfunction of fronto-striatal circuitry (summary see Stocchi & Brusa, 2000). Executive function impairments may already be present in early stages of PD (Uekermann et al., 2004) and their severity may be exacerbated by affective changes such as depression (Uekermann et al., 2003). In addition to cognitive problems, PD patients frequently suffer from mood changes, in particular apathy (Kirsch-Darrow et al., 2006) and from affect processing impairments, relating to both the ability to decode the affective state of other people on the basis of facial expressions or prosody and to the ability to adequately express the patients' own emotions (e.g. Breitenstein et al., 1998; Zgaljardic et al., 2003, Pell & Leonard, 2005). The capacity for emotion perception was found to be linked to the severity of executive dysfunction; affective and cognitive changes are thus not independent, at least in patients with moderate PD (Breitenstein et al., 2001).
In a recent drug monitoring study by Lundbeck GmbH/TEVA Pharma GmbH based on a small group of PD patients (n=29), introduction of Azilect (Rasagiline) therapy was associated with a significant improvement of PD patients' emotional expressiveness (e.g. facial expression, gestures, voice intonation) over an 8 week observation period. Significant improvements were observed for self-ratings of emotional expressiveness as well as ratings by physicians and relatives. The lack of a placebo-control group, however, does not allow any firm conclusions with regard to the specificity of these effects.
Intact affect recognition and an adequate ability to express emotions are of critical importance for social interaction. The therapeutic efficacy of drug treatment on non-motor symptoms in PD has so far only rarely been addressed. The documentation of a beneficial effect of Azilect on emotional processing would be of great relevance for the quality of life of PD patients and greatly enhance their ability to participate in social life.
The addition of a placebo control group is critical for the assessment of the specificity of the expected beneficial effects of Azilect.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Parkinson Disease, Emotion, mood, executive function
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo 1 Tbl per day, 12 week (84 days) duration
Arm Title
Rasagiline
Arm Type
Active Comparator
Arm Description
Azilect Group: Dose: 1 mg per day, 12 week (84 days) duration
Intervention Type
Drug
Intervention Name(s)
Rasagiline
Other Intervention Name(s)
Azilect EU/1/04/304/001-007
Intervention Description
Azilect Group: Dose: 1 mg per day, 12 week (84 days) duration
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo 1 Tbl per day, 12 week (84 days) duration
Primary Outcome Measure Information:
Title
Assess the effect of Azilect on mood, recognition of facial and vocal affect and emotional expressiveness
Description
Discrimination Faces
Discrimination Affect
Affect Naming -Faces
Discrimination linguistic prosody
Discrimination affective prosody
Affect naming -congruent and incongruent affective prosody Visual Analogue Scales of emotional expressiveness
Rating by study physician and relative
Self-rating by patient Assessment of executive function
Working Memory (n-back task, digit backward)
Verbal Fluency (Regensburger Wortflüssigkeitstest) Beck Depression Inventary (BDI) Apathie Evaluations-Skala (AES) Social Activity Scale - self assessment PDQ-39- self-assessment
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Effect on motor function in PD
Description
Unified Parkinson's Disease Rating Scale
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
idiopathic PD
age range 30-75 yrs, HY I-III
stable medication for at least 4 weeks prior to baseline
Native speakers (German)
signing of informed consent form
Exclusion Criteria:
clinically significant depression (BDI>13)
freezing, pronounced fluctuations
other neurological or psychiatric disorders
dementia (MMSE<25)
treatment with the MAO-B-inhibitor Selegiline, antidepressants
any contraindication according to SmPC
participation in another interventional study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dirk Woitalla, MD
Phone
0049234509
Ext
2403
Email
dirk.woitalla@rub.de
First Name & Middle Initial & Last Name or Official Title & Degree
Anke Hartung
Phone
0049234509
Ext
2403
Email
a.hartung@klinikum-bochum.de
Facility Information:
Facility Name
St. Josef Hospital
City
Bochum
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
44791
Country
Germany
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dirk Woitalla, MD
First Name & Middle Initial & Last Name & Degree
Irene Daum, Prof.
12. IPD Sharing Statement
Citations:
PubMed Identifier
20829664
Citation
Roca M, Torralva T, Gleichgerrcht E, Chade A, Arevalo GG, Gershanik O, Manes F. Impairments in social cognition in early medicated and unmedicated Parkinson disease. Cogn Behav Neurol. 2010 Sep;23(3):152-8. doi: 10.1097/WNN.0b013e3181e078de.
Results Reference
background
PubMed Identifier
20310053
Citation
Rosenthal E, Brennan L, Xie S, Hurtig H, Milber J, Weintraub D, Karlawish J, Siderowf A. Association between cognition and function in patients with Parkinson disease with and without dementia. Mov Disord. 2010 Jul 15;25(9):1170-6. doi: 10.1002/mds.23073.
Results Reference
background
PubMed Identifier
16960473
Citation
Scholtissen B, Verhey FR, Adam JJ, Weber W, Leentjens AF. Challenging the serotonergic system in Parkinson disease patients: effects on cognition, mood, and motor performance. Clin Neuropharmacol. 2006 Sep-Oct;29(5):276-85. doi: 10.1097/01.WNF.0000229013.95927.C7.
Results Reference
background
PubMed Identifier
9595982
Citation
Growdon JH, Kieburtz K, McDermott MP, Panisset M, Friedman JH. Levodopa improves motor function without impairing cognition in mild non-demented Parkinson's disease patients. Parkinson Study Group. Neurology. 1998 May;50(5):1327-31. doi: 10.1212/wnl.50.5.1327.
Results Reference
background
PubMed Identifier
20714063
Citation
Timmann D, Daum I. How consistent are cognitive impairments in patients with cerebellar disorders? Behav Neurol. 2010;23(1-2):81-100. doi: 10.3233/BEN-2010-0271.
Results Reference
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Emotion, Mood and Executive Function in Parkinson's Disease (PD)
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