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NCT Number: NCT07265323

Effect of Physiologic Insulin Administration 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.

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Key information

Conditions

Alzheimer s Disease Alzheimer Blood Biomarkers Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Insulin Sensitivity Mental Disorders Metabolic Diseases Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Nutritional and Metabolic Diseases Tauopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70806, United States

Location status: Recruiting

Location contact

Candida Rebello, Ph.D.

CONTACT

[email protected]

Tim Gilbert, Dr

CONTACT

[email protected]

2257632584

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Physiological Insulin Intervention

Other

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.

Primary outcomes

  1. 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.

  2. 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.

  3. Insulin Sensitivity

    Time frame: Over a six-month period

    Insulin sensitivity (glucose disposal rate measured during a hyperinsulinemic euglycemic clamp)

Secondary outcomes

  1. Brain Glucose Uptake

    Time frame: Six months

    We will measure brain glucose uptake using FDG-PET.

Study contacts

Contact information is provided by the study sponsor or research team.

Candida Rebello, Ph.D.

CONTACT

[email protected]

2257633159

Tim Gilbert, M.D.

CONTACT

[email protected]

2257632584

Sponsors and collaborators

Lead sponsor

Pennington Biomedical Research Center

Other

Registry information

Official study title

Effect of Physiologic Insulin Intervention on Insulin Sensitivity and Cognition

Acronym: MIND-IT

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Dec 4, 2025
Registry last updated
Dec 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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