Alzheimer s DiseaseMIND-ITNCT07265323
Effect of Physiologic Insulin Administration on Insulin Sensitivity and Cognition
A study testing Physiological Insulin Intervention in people with Alzheimer s Disease and Alzheimer Blood Biomarkers, run by Pennington Biomedical Research Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alzheimer s Disease, Alzheimer Blood Biomarkers, Insulin Sensitivity
- What is being tested?
- Physiological Insulin Intervention
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2025to May 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Mini Mental State Examination (MMSE) score < 25
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70806
Tim Gilbert, Dr, 2257632584, Tim.Gilbert@pbrc.edu
Candida Rebello, Ph.D., candida.rebello@pbrc.edu
About this study
Official title: 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:
Read more
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.
- Being tested
- Physiological Insulin Intervention
- Keywords
- Alzheimer's disease, Insulin Sensitivity
- Medical subject headings
- Insulin Resistance, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physiological Insulin InterventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Physiologic Insulin | Experimental | 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. Receives: Other: Physiological Insulin Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognition
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.
Measured: Over a six-month period
Cognition
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.
Measured: Over a six-month period
Insulin Sensitivity
Insulin sensitivity (glucose disposal rate measured during a hyperinsulinemic euglycemic clamp)
Measured: Over a six-month period
Secondary outcomes (1)
Brain Glucose Uptake
We will measure brain glucose uptake using FDG-PET.
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2025
- Study startDec 2025 (estimated)
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer s DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pennington Biomedical Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tim Gilbert, Pennington Biomedical Research Center
- Investigators
- Tim Gilbert, M.D., Principal investigator, Pennington Biomedical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07265323
- Sponsor's protocol ID
- 2025-019-PBRC
- Other IDs
- PBRC Foundation funds
- Acronym
- MIND-IT
- Status last verified
- Nov 2025
- First submitted
- 18 Nov 2025
- Last updated
- 4 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No