Long-acting Exenatide and Cognitive Decline in Dysglycemic Patients

• Status: Active, not recruiting
• Trial end date: 2021-10-31
• Target enrollment: 0
• Participant gender: All

Summary

The overall objective of the study is to assess the potential effects of the long-acting GLP-1 analogue exenatide in preventing/slowing the progression of cognitive dysfunction and related biomarkers in dysglycemic/prediabetic patients with mild cognitive impairment (MCI).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Azienda Ospedaliero-Universitaria di Parma
• Treatments: Exenatide

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.