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

June 29, 2011 updated by: St. Josef Hospital Bochum

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

70

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Germany
    • Nordrhein-Westfalen
      • Bochum, Nordrhein-Westfalen, Germany, 44791
        • St. Josef Hospital
        • Principal Investigator:
          • Dirk Woitalla, MD
        • Sub-Investigator:
          • Irene Daum, Prof.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Placebo 1 Tbl per day, 12 week (84 days) duration
Drug: Placebo
Placebo 1 Tbl per day, 12 week (84 days) duration
Active Comparator: Rasagiline
Azilect Group: Dose: 1 mg per day, 12 week (84 days) duration
Drug: Rasagiline
Azilect Group: Dose: 1 mg per day, 12 week (84 days) duration
Other Names:
  • Azilect EU/1/04/304/001-007

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess the effect of Azilect on mood, recognition of facial and vocal affect and emotional expressiveness
Time Frame: 12 weeks
  • 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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect on motor function in PD
Time Frame: 12 weeks
Unified Parkinson's Disease Rating Scale
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Josef Hospital Bochum

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Anticipated)

October 1, 2012

Study Completion (Anticipated)

April 1, 2013

Study Registration Dates

First Submitted

June 28, 2011

First Submitted That Met QC Criteria

June 29, 2011

First Posted (Estimate)

June 30, 2011

Study Record Updates

Last Update Posted (Estimate)

June 30, 2011

Last Update Submitted That Met QC Criteria

June 29, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011-TevAzi

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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