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DRINN

UnknownPhase 3

Long-acting Exenatide and Cognitive Decline in Dysglycemic Patients

Long-acting Exenatide: a Tool to Stop Cognitive Decline in Dysglycemic Patients With Mild Cognitive Impairment?

Lead sponsor

Azienda Ospedaliero-Universitaria di Parma

Asset

Exenatide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

estimated

Study population

Alzheimer's / cognition, Prediabetes / glucose intolerance

Key I/E criterion

•HbA1c 5.7-6.4%

Primary endpoint

•Improvement of ADAS-cog Alzheimer's Disease Assessment Scale

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT02847403

Org study ID2015-001850-13

Timeline

Milestones

Study first posted2016-07-28estimated

Last update posted2021-08-17actual

Study completion2021-10-31estimated

Study start2016-02 (month precision)

Primary completion2019-07actual (month precision)

Assets

Investigational agents

Exenatide

Study populations

Who this study enrolls

Alzheimer's / cognitionPrediabetes / glucose intolerance

Eligibility

Who can enroll

Minimum age51 Years

Maximum age79 Years

SexAll

Healthy volunteersNot accepted

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.

Endpoints (11)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other clinical outcomes

Patient-reported / QoL

1 endpoint

Secondary/protocol endpoint

Improvement of Geriatric Depression Scale (GDS) test at 16 (V2) and at 32 weeks (V3) compared to baseline

Time frame:16 and 32 weeks