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

Pennington Biomedical Research Center

Status: Enrolling

Conditions: Alzheimer s Disease; Alzheimer Blood Biomarkers; Insulin Sensitivity

Treatments: Other: Physiological Insulin Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT07265323

PBRC Foundation funds (Other Identifier)

2025-019-PBRC

Details and patient eligibility

About

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.

Enrollment: 8 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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8 participants in 1 patient group

Physiologic Insulin

Experimental group

Description:

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.

Treatment:

Other: Physiological Insulin Intervention