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 @ 8:02 PM
Ignite Modification Date:
2025-12-24 @ 8:02 PM
NCT ID:
NCT04810104
Eligibility Criteria:
Inclusion Criteria:
* Aged between 50 to 80 years (inclusive) at time of consent
* Duration of motor symptoms of at least 1 year
* Hoehn and Yahr stage between 1 and 3 (inclusive) in ON state
* Diagnosis of PD according to United Kingdom (UK) Brain Bank criteria
* Score on Clinical Dementia Rating (CDR) scale = 0.5
* Diagnosis of PD-MCI according to MDS PD-MCI, Level I criteria
* Duration of cognitive impairment of at least 3 months (to distinguish from mild delirium)
Exclusion Criteria:
* Insufficient fluency in English or local language to complete assessments
* Severe visual or auditory impairment that may interfere with participant's ability to complete assessments
* Unable to provide informed consent at screening visit
* Participation in a clinical study involving an investigational drug within 4 months prior to screening
* Smoking (cigarettes, pipes, cigars, e-cigarettes etc.) or use of smokeless tobacco products (chewing / dipping tobacco, snuff etc.) or anti-smoking nicotine containing products (patches/gum/sprays etc.), within the last 12 weeks
* HADS depression subscale score ≥ 11
* History of deep brain stimulation or other neurosurgical procedure
* Diagnosis of dementia, including Parkinson's disease dementia (PDD) or Dementia with Lewy Bodies (DLB).
* Diagnosis of schizophrenia, bipolar disorder or other psychotic disorder
* Malignant neoplasms within 3 years of screening (except for basal or squamous cell carcinoma of the skin); or had curative surgery/treatment and has been free of malignancy for at least 12 months)
* Any medical condition that in the opinion of the investigator may be contributing to cognitive impairment, above and beyond that caused by the participant's PD,
* Current evidence of any other medical condition not stably or adequately controlled, and which in the opinion of the investigator may affect participant safety or study participation
* Using any prohibited medications or permitted medications that do not meet stable dosing regimen requirements, as specified in section 5.7
* Clinically significant vital sign or ECG measure at screening or baseline visit, that in the opinion of the investigator would prevent participant from safely participating in this study
* Clinically significant clinical laboratory result from screening visit, that in the opinion of the investigator would prevent participant from safely participating in this study
* Significant renal function impairment as indicated by estimated glomerular filtration rate (eGFR) \< 45ml/min); Note: The eGFR is calculated using a formula derived from the Modification of Diet in Renal Disease Study (MDRD formula): eGFR= \[186.3 x (Creatinine/88.4)-1.154 x (Age)-0.203\] x \[0.742 if female\] x \[1.210 if black\]
* Unable to complete computerised cognitive test battery
* Marked cerebrovascular disease from MRI or CT scan within last 12 months (defined as Fazekas scale ≥ grade 3)
* Females who are breast-feeding
* Female participants assessed as being of child-bearing potential that have a positive pregnancy test at screening or baseline
* The participant does not understand or agree to comply with the contraception or reproductive requirements of the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
80 Years
Study:
NCT04810104
Study Brief:
Protocol Section:
NCT04810104