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 @ 7:22 PM
Ignite Modification Date:
2025-12-24 @ 7:22 PM
NCT ID:
NCT02847403
Eligibility Criteria:
Inclusion Criteria:
* patients capable of giving informed consent
* dysglycemia/prediabetes defined as fasting plasma glucose between 100 and 125 mg/dl and/or 2-hour plasma glucose between 140 and 199 mg/dl after a 75 g OGTT and/or a HbA1c value between 5.7 and 6.4%
* diagnosis of MCI according to the Petersen clinical criteria (the expected corrected scores at the MMSE are from 24 to 27)
* age \>50\<80 yrs
* stable medication for the past 3 months
* Caucasian ethnicity
Exclusion Criteria:
* age \<50\>80 yrs
* incapability to give informed consent
* diabetes defined according to American Diabetes Association (ADA) criteria
* clinically significant liver or kidney dysfunction defined as s-ALT \> 2 times upper reference or estimated creatinine-clearance (eGFR) \< 60 mL / min/1.73m2, assessed by with CKD-EPI formula
* endocrinological diseases other than well controlled hypothyroidism, personal or family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia (MEN) syndrome, severe gastro-intestinal diseases (i.e gastroparesis, dumping syndromes), current or history of chronic or acute pancreatitis
* any contraindication to the use of exenatide as per the Summary of Product Characteristics
* known abuse of alcohol or drugs
* ferro-magnetic prosthesis, pacemaker or other metals incorporated in the body
* significant neurologic disease other than MCI (i.e. Parkinson's disease, multiple system atrophy, normal pressure hydrocephalus, progressive supranuclear palsy, subarachnoid hemorrhage, brain neoplasms, Huntington disease, epilepsy or head trauma)
* BMI ≤22 Kg/m2 in subject ≥ 70 yrs
* MRI/CT showing unambiguous etiological evidence of cerebrovascular disease with regard to MCI
* severe sensory defects; current presence of clinically significant psychiatric disorder
* warfarin treatment, clinically significant systemic condition
* history of cancer within the last 5 yrs
* known allergy to exenatide or any of the other components.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
51 Years
Maximum Age:
79 Years
Study:
NCT02847403
Study Brief:
Protocol Section:
NCT02847403