Olfaction in Patients With Parkinson's Disease Following Treatment With Rasagiline

Study Overview
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Brief Summary
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There is convincing evidence from numerous studies using both psychophysical and electrophysiological approaches that olfaction is markedly reduced in Parkinson´s disease (PD). Data on the prevalence of olfactory dysfunction in PD however, range from 45% and 49% in the pioneering studies of Ansari & Johnson, and Ward, respectively, up to 74% in the work of Hawkes et al., or as high as 90% in a study published by Doty et al. Quality of life, safety, and interpersonal relations, as well as food behavior/nutritional intake are severely altered in a large proportion of patients with olfactory loss. Thus, the same can be assumed in patients with Parkinson's disease. If it was possible to improve olfactory function this would appear as a significant effect in patients with Parkinson's disease. Provided the study would reveal an improvement of olfactory function following therapy with rasagiline, this would have tremendous worldwide impact on the use of this drug. Considering the frequency of PD a very large number of patients would benefit from these findings, especially in terms of quality of life.

Official Title
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Reversibility of Olfactory Loss in Patients With Idiopathic Parkinson's Disease Following Treatment With Rasagiline

Conditions
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Parkinson´s Disease

Intervention / Treatment
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* Drug: Azilect 1mg
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Parkinson´s disease, Hoehn & Yahr stage ≤ III aged 18-64 yrs hyposmia/functional anosmia defined as TDI<30 written consent Exclusion Criteria: congenital olfactory loss significant infections of the nose and nasal sinuses diseases/states apart from PD which may significantly affect olfactory function, e.g., asthma, head trauma etc. dementia, psychiatric illness, addictive behaviour smoker severe liver disease pregnant or breastfeeding women any contraindication for the treatment with Rasagiline women without reliable contraception

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rasagiline<br> | Drug: Azilect 1mg<br>* 1 mg daily orally for 120 days<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* 1 mg daily orally for 120 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| olfactory function |  | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| quality of life |  | 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parkinson´s disease, olfaction, rasagiline, smell testing