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

Technische Universität Dresden

Status and phase: Completed; Phase 4

Conditions: Parkinson´s Disease

Treatments: Drug: Azilect 1mg; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00902941

TUD-Olfact-035

2008-005085-30

Details and patient eligibility

About

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.

Enrollment: 34 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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34 participants in 2 patient groups, including a placebo group

Rasagiline

Experimental group

Treatment:

Drug: Azilect 1mg

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo