Emotion, Mood and Executive Function in Parkinson's Disease (PD)
NCT ID: NCT01385735
Last Updated: 2011-06-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE4
70 participants
INTERVENTIONAL
2011-10-31
2013-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Placebo
Placebo 1 Tbl per day, 12 week (84 days) duration
Placebo
Placebo 1 Tbl per day, 12 week (84 days) duration
Rasagiline
Azilect Group: Dose: 1 mg per day, 12 week (84 days) duration
Rasagiline
Azilect Group: Dose: 1 mg per day, 12 week (84 days) duration
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Rasagiline
Azilect Group: Dose: 1 mg per day, 12 week (84 days) duration
Placebo
Placebo 1 Tbl per day, 12 week (84 days) duration
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
30 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
St. Josef Hospital Bochum
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Neurologische Universitätsklinik der Ruhr-Universität Bochum
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
St. Josef Hospital
Bochum, North Rhine-Westphalia, Germany
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2011-TevAzi
Identifier Type: -
Identifier Source: org_study_id