Parkinson DiseasePhase 4RasQNCT01385735
Emotion, Mood and Executive Function in Parkinson's Disease (PD)
A Phase 4 study testing Rasagiline in people with Parkinson Disease, run by St. Josef Hospital Bochum at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Rasagiline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2011to Apr 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
St. Josef Hospital
Bochum, North Rhine-Westphalia, 44791
Dirk Woitalla, MD
Irene Daum, Prof.
About this study
Official title: 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.
Read the 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.
- Conditions
- Parkinson Disease
- Being tested
- Rasagiline, Placebo
- Keywords
- Parkinson Disease, Emotion, mood, executive function
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RasagilineDrug
Also called Azilect EU/1/04/304/001-007
Azilect Group: Dose: 1 mg per day, 12 week (84 days) duration
PlaceboDrug
Placebo 1 Tbl per day, 12 week (84 days) duration
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo 1 Tbl per day, 12 week (84 days) duration Receives: Drug: Placebo |
| Rasagiline | Active comparator | Azilect Group: Dose: 1 mg per day, 12 week (84 days) duration Receives: Drug: Rasagiline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 weeks
Secondary outcomes (1)
Effect on motor function in PD
Unified Parkinson's Disease Rating Scale
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2011 (estimated)
- Study startOct 2011
- Primary completionOct 2012 (estimated)
- Study completionApr 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Josef Hospital Bochum
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01385735
- Sponsor's protocol ID
- 2011-TevAzi
- Acronym
- RasQ
- Status last verified
- Jun 2011
- First submitted
- 28 Jun 2011
- Last updated
- 30 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 20829664Rosenthal 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.
PubMed 20310053Scholtissen 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.
PubMed 16960473Growdon 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.
PubMed 9595982Timmann 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.
PubMed 20714063
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Azilect (Rasagiline) on Processing of Emotions, Mood and Executive Function in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT01385735
- Acronym / sponsor ID
- RasQ / 2011-TevAzi
- Conditions
- Parkinson Disease
- Keywords
- Parkinson Disease, Emotion, mood, executive function
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- St. Josef Hospital BochumUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Oct 2012 (estimated)
- Study completion
- Apr 2013 (estimated)
- First posted
- 30 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo 1 Tbl per day, 12 week (84 days) duration |
| Rasagiline | Active comparator | Drug: RasagilineAzilect Group: Dose: 1 mg per day, 12 week (84 days) duration |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- clinically significant depression (BDI>13)
- freezing, pronounced fluctuations
- other neurological or psychiatric disorders
- dementia (MMSE<25)
- treatment with the MAO-B-inhibitor Selegiline, antidepressants
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RasagilineAlso: Azilect EU/1/04/304/001-007Azilect Group: Dose: 1 mg per day, 12 week (84 days) duration | Drug | Rasagiline |
| PlaceboPlacebo 1 Tbl per day, 12 week (84 days) duration | Drug | Placebo |
Primary outcome
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
1 secondary outcome
Effect on motor function in PD
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2011.
- Background: PubMed 20829664Roca 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.
- Background: PubMed 20310053Rosenthal 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.
- Background: PubMed 16960473Scholtissen 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.
- Background: PubMed 9595982Growdon 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.
- Background: PubMed 20714063Timmann 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rasagiline in people with Parkinson Disease, run by St. Josef Hospital Bochum at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dirk Woitalla, MD (0049234509 ext. 2403, dirk.woitalla@rub.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess the effect of Azilect on mood, recognition of facial and vocal affect and emotional expressiveness (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01385735, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2011.