Long-acting Exenatide and Cognitive Decline in Dysglycemic Patients

What Was Tested

The trial (phase 3) is built around Exenatide.

It had two arms (groups): exenatide (experimental) and placebo (placebo comparator).

No drug assigned.

The registry classes the interventions as drug and other.

More on the Plan

Impaired insulin signaling is critically involved in the natural history of both T2DM and AD and it may represent a common mechanistic link ("common soil") between dysglycemic/prediabetic states and AD development and progression.

All eligible patients at V0 will undergo baseline assessments (V1) and will be allocated according to the procedure of randomization to one of the study arms.

Follow-up (FU) visits for all subjects will be at 16 (V2) and at 32 weeks (V3) after randomization.

Additionally, subjects on active treatment will be admitted weekly to the Outpatient Diabetes Unit of the AOUPR for GLP-1 subcutaneous injections and to check for possible side effects.

Who Took Part

40 planned participants were the target.

It was open to people of any sex aged from 51 years up to 79 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Patients capable of giving informed consent. 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.

The full record lists 6 inclusion and 15 exclusion criteria; among the exclusions: age \<50\>80 yrs; incapability to give informed consent; diabetes defined according to american diabetes association (ada) criteria.

How the Study Was Run

Design: randomized, parallel-group and open-label.

Random assignment meant chance, not the researchers, decided who got Exenatide and who got the comparison, which limits bias.

The Exenatide group and the comparison group ran side by side rather than switching.

Being open-label, the Exenatide study did not mask who received what.

It started in 2016-02 with completion listed for 2019-07.

It ran at 2 sites in Italy (2).

Its stated primary purpose is treatment.

What Was Measured

It also tracked 10 secondary outcomes, for example changes in structural and functional connectivity of neural networks as assessed by functional MRI (fMRI) at 16 (V2) and at 32 weeks (V3).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Exenatide in 40 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Exenatide compound page, all human trials.