Emotion, Mood and Executive Function in Parkinson`s Disease (PD)

Parkinson Disease Clinical Trial

— RasQ  

Official title:

Effects of Azilect (Rasagiline) on Processing of Emotions, Mood and Executive Function in Parkinson`s Disease

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01385735
• Other study ID #: 2011-TevAzi
• Status: Not yet recruiting
• Phase: Phase 4
• First received: June 28, 2011
• Last updated: June 29, 2011
• Start date: October 2011
• Est. completion date: April 2013

Study information

• Verified date: June 2011
• Source: St. Josef Hospital Bochum
• Contact: Dirk Woitalla, MD
• Phone: 0049234509
• Email: dirk.woitalla[@]rub.de
• Is FDA regulated: No
• Health authority: Germany: German Institute of Medical Documentation and Information
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 70
• Est. completion date: April 2013
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Drug:
• Rasagiline
Azilect Group: Dose: 1 mg per day, 12 week (84 days) duration
• Placebo
Placebo 1 Tbl per day, 12 week (84 days) duration

Locations

Country	Name	City	State
Germany	St. Josef Hospital	Bochum	Nordrhein-Westfalen

Sponsors (1)

Lead Sponsor	Collaborator
St. Josef Hospital Bochum

Country where clinical trial is conducted

Germany, 

References & Publications (5)

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. — View Citation

Roca M, Torralva T, Gleichgerrcht E, Chade A, Arévalo 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. — View 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. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	12 weeks	No
Secondary	Effect on motor function in PD	Unified Parkinson's Disease Rating Scale	12 weeks	No