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:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2025-12-25 @ 2:00 AM
NCT ID:
NCT01251094
Eligibility Criteria:
Inclusion Criteria:
1. The patient who is diagnosed as clinical PD with and without dementia according to the DSM-IV criteria \[3\] will be invited for this study. The diagnosis of clinical PD is according to the UK Parkinson's Disease Society Brain Bank clinical diagnostic criteria \[17\]. The initial symptom more than one year of clinical PD will be invited for this study.
2. A reliable caregiver who lives with the subjects or has at least 10 hours/week of contact with the subject.
3. Males and females between the ages of 50 and 90 years, inclusive.
4. Adequate visual and auditory abilities to perform all aspects of the study assessments.
Exclusion Criteria:
Presence of any of the following criteria will exclude the subject from enrollment in the study:
1. Significant neurological disease other than PD that may affect cognition.
2. Current clinically important systemic illness that is likely to result in deterioration of the subject's condition or affect the subject's safety during the study.
3. History of clinically evident stroke.
4. History of seizures within the past 5 years
5. Myocardial infarction within the past one year prior to screening
6. Current DSM-IV-TR diagnosis of substance abuse or dependence (including alcohol abuse or dependence but excluding nicotine dependence) or history of substance dependence within the past 2 years to screening.
7. Regular use of anticholingeric drugs within 60 days prior to screening.
8. The subject received deep brain stimulation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
90 Years
Study:
NCT01251094
Study Brief:
Protocol Section:
NCT01251094