Effect of Physiologic Insulin Administration on Insulin Sensitivity and Cognition (MIND-IT)

December 2, 2025 updated by: Tim Gilbert, Pennington Biomedical Research Center

Effect of Physiologic Insulin Intervention on Insulin Sensitivity and Cognition

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

8

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Mini Mental State Examination (MMSE) score < 25

Exclusion Criteria:

  • On daily medication for the specific treatment of anxiety including benzodiazepines.
  • An infant, child, or teenager
  • A pregnant woman
  • A prisoner
  • Having any condition that impedes testing of the study hypothesis or are otherwise deemed to be unsuitable (determined by the investigative team).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Physiologic Insulin
Insulin infusion at five-minute intervals over approximately two hours weekly for six months. Initially infusion will be weekly and then frequency will reduce based on participants' response.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cognition
Time Frame: Over a six-month period
Cognition will be assessed using Montreal Cognitive Assessment (MoCA). The MoCA test scores range from 0 to 30, with a higher score indicating a better outcome.
Over a six-month period
Cognition
Time Frame: Over a six-month period
Cognition will be assessed using the Revised Memory and Behavior Problems Checklist (RMBPC). The two subscales are frequency and reaction. The score for each subscale ranges from 0 to 96. A lower score indicates a better outcome.
Over a six-month period
Insulin Sensitivity
Time Frame: Over a six-month period
Insulin sensitivity (glucose disposal rate measured during a hyperinsulinemic euglycemic clamp)
Over a six-month period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Brain Glucose Uptake
Time Frame: Six months
We will measure brain glucose uptake using FDG-PET.
Six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pennington Biomedical Research Center

Investigators

  • Principal Investigator: Tim Gilbert, M.D., Pennington Biomedical Research Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2025

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 1, 2027

Study Registration Dates

First Submitted

November 18, 2025

First Submitted That Met QC Criteria

December 2, 2025

First Posted (Estimated)

December 4, 2025

Study Record Updates

Last Update Posted (Estimated)

December 4, 2025

Last Update Submitted That Met QC Criteria

December 2, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-019-PBRC
  • PBRC Foundation funds (Other Identifier: Pennington Biomedical Research Foundation)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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