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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Physiologic Insulin Intervention on Insulin Sensitivity and Cognition
- ClinicalTrials.gov ID
- NCT07265323
- Acronym / sponsor ID
- MIND-IT / 2025-019-PBRC
- Keywords
- Alzheimer's disease, Insulin Sensitivity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- Pennington Biomedical Research CenterUniversity, hospital or other
- Study start
- Dec 2025 (estimated)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 4 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Physiologic Insulin | Experimental | Other: Physiological Insulin InterventionInsulin 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Mini Mental State Examination (MMSE) score < 25
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physiological Insulin InterventionInsulin 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. | Other | Physiologic Insulin |
Primary outcome
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.
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.
Insulin Sensitivity
Time frame: Over a six-month period
Insulin sensitivity (glucose disposal rate measured during a hyperinsulinemic euglycemic clamp)
1 secondary outcome
Brain Glucose Uptake
Time frame: Six months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tim Gilbert, M.D. principal investigator
Pennington Biomedical Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tim Gilbert, M.D. (2257632584, Tim.Gilbert@pbrc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognition (time frame: Over a six-month period). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2025.