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 @ 9:17 PM
Ignite Modification Date:
2025-12-24 @ 9:17 PM
NCT ID:
NCT01216904
Eligibility Criteria:
Inclusion Criteria:
* A clinical diagnosis of idiopathic Parkinson's Disease based on movement disorders specialist assessment using the National Institute of Neurological disorders and Stroke (NINDS) criteria 17;
* demonstrated response to L-¬DOPA and/or dopamine agonists;
* Hoehn and Yahr19 stage 1 - 3 motor disability in the "on" medication state;
* stable PD and non-PD medications for at least 1 month prior to baseline;
* positive QUIP screening and confirmatory interview for current or prior ICD symptoms 36;
* Montreal Cognitive Assessment score \> 24;
* impaired impulsive and/or compulsive responding compared to norms on Stop Signal Task and/or Set-Shifting Task
* Global Deterioration Scale score24 of 1-2;
* Adequate visual and auditory acuity for neuropsychological testing;
* good general health with no additional diseases expected to interfere with the study;
* normal laboratory tests and ECG;
* female participants must be non-breastfeeding, post-menopausal or have been surgically sterilized or have a negative urine pregnancy test at screening and baseline visits with an acceptable form of contraception being used (see drug safety section for details on acceptable contraception);
* Subjects will be taking no centrally active or anti or pro-cholinergic drugs;
* non¬smokers, defined as no cigarettes in the last 6 months
Exclusion Criteria:
* severe motor fluctuations;
* prior DBS surgery;
* Any significant systemic illness or unstable medical condition including serious heart disease, severe asthma, severe or active ulcer disease, active thyroid disease, pyloric stenosis epilepsy, or allergies to nicotine;
* clinically significant laboratory test abnormalities on the battery of screening tests (hematology, chemistry, urinalysis, ECG);
* uncontrolled hypertension (systolic BP\> 170 or diastolic BP\> 100);
* Any current significant or unstable depression, anxiety, or psychosis
* history of obsessive-compulsive disorder
* use of any investigational drugs within 30 days or 5 half-¬lives, whichever is longer, prior to screening
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01216904
Study Brief:
Protocol Section:
NCT01216904