Recruiting

Insulin

Sponsor:

Pennington Biomedical Research Center

Code:

NCT07265323

Conditions

Alzheimer s Disease

Alzheimer Blood Biomarkers

Insulin Sensitivity

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Physiological Insulin Intervention

Study Details

Brief 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

Study ID

NCT07265323

Start date

Dec, 2025

Status verified date

Nov, 2025

Completion date

May, 2027

Anticipated

Primary completion date

May, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

8 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

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.

Primary outcome measure

  • Cognition [ Time Frame: Over a six-month period ]
  • Cognition [ Time Frame: Over a six-month period ]
  • Insulin Sensitivity [ Time Frame: Over a six-month period ]

Central Contacts and Locations

Central contacts

Tim Gilbert, M.D.

2257632584Tim.Gilbert@pbrc.edu

Candida Rebello, Ph.D.

2257633159Candida.Rebello@pbrc.edu

Locations

Pennington Biomedical Research Center

Recruiting

Baton Rouge, Louisiana, United States, 70806

Contacts

Tim Gilbert, Dr

2257632584Tim.Gilbert@pbrc.edu

Candida Rebello, Ph.D.

candida.rebello@pbrc.edu

More Information

Sponsor

Pennington Biomedical Research Center

Last update posted

Dec 4, 2025

Last verified

Nov, 2025

Keywords

  • Alzheimer's disease
  • Insulin Sensitivity

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Pennington Biomedical Research Center on 2025-12-04.