NCT07265323

Effect of Physiologic Insulin Administration on Insulin Sensitivity and Cognition

Effect of Physiologic Insulin Intervention on Insulin Sensitivity and Cognition

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 8 (estimated)
• Sponsor: Pennington Biomedical Research Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to determine if a weekly delivery of insulin at short intervals lasting up to 2 hours can improve insulin sensitivity and cognition in adults with Alzheimer's Disease. It will also provide information about the safety and feasibility of this intervention. The main questions it aims to answer are: Does the intervention improve insulin sensitivity (how the body uses glucose)? Does the intervention improve cognition, measured by the Montreal Cognitive Assessment (MoCA) and the Revised Memory and Behavior Problems Checklist (RMBPC)? What changes occur in brain glucose uptake (FDG-PET)? Participants will: Receive the intervention once a week for 6 months, with each session lasting up to 2 hours Complete cognitive assessments. Adverse events will be assessed throughout the study.

Conditions

• Alzheimer s Disease
• Alzheimer Blood Biomarkers
• Insulin Sensitivity

Interventions

Type	Name	Description
OTHER	Physiological Insulin Intervention	Insulin infusion every five minutes over approximately two hours for six months. Initially infusion will be weekly and then frequency will reduce based on participants' response.

Timeline

• Start date: 2025-12-01
• Primary completion: 2027-05-01
• Completion: 2027-05-01
• First posted: 2025-12-04
• Last updated: 2025-12-04

Locations

1 site across 1 country: United States