Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:43 PM
Ignite Modification Date:
2025-12-24 @ 6:43 PM
NCT ID:
NCT01765257
Eligibility Criteria:
Inclusion Criteria:
\- Drug-naïve patients with Parkinson's disease (UKPDBB criteria)
* No dementia (Mattis dementia rating scale \> 130; Mini Mental Sate Examination ≥26)
* No depression (MADRS \< 15)
* Criteria of apathy from Robert et al (2009)
* At least mild apathy (≥-21 to Lille Apathy Rating Scale)
* Age : 35-70 y
* Affiliation to social security
* Agreement of patients
Exclusion Criteria:
* \- Any antiparkinsonian treatment (L.dopa, dopamine agonists, MAO-B-I, amantadine, anticholinergics). Patients treated by dopamine agonists but who have stopped it more than 3 months before their inclusion can be included.
* Ongoing severe psychiatric or somatic diseases
* Others treatments :
* antipsychotics
* antidepressants and anxiolytics (exclusion if the treatment is not stable the month before inclusion)
* psychostimulants (methylphenidate, adrafinil, modafinil, deanol, vitamin C, sulbutiamine, glutamic acid, aspartic acid)
* any contra-indication according to SmPC
* patients under guardianship
* Women without efficient contraception
* Person who participate to an other study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
70 Years
Study:
NCT01765257
Study Brief:
Protocol Section:
NCT01765257