NCT07265323

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
12mo left

Started Dec 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress31%
Dec 2025May 2027

First Submitted

Initial submission to the registry

November 18, 2025

Completed
13 days until next milestone

Study Start

First participant enrolled

December 1, 2025

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 4, 2025

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Last Updated

December 4, 2025

Status Verified

November 1, 2025

Enrollment Period

1.4 years

First QC Date

November 18, 2025

Last Update Submit

December 2, 2025

Conditions

Alzheimer s DiseaseAlzheimer Blood BiomarkersInsulin Sensitivity

Keywords

Alzheimer's diseaseInsulin Sensitivity

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    Over a six-month period

  • Insulin Sensitivity

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

    Over a six-month period

Secondary Outcomes (1)

  • Brain Glucose Uptake

    Six months

Study Arms (1)

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.

Other: Physiological Insulin Intervention

Interventions

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.

Physiologic Insulin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Mini Mental State Examination (MMSE) score \< 25

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70806, United States

RECRUITING

MeSH Terms

Conditions

Insulin ResistanceAlzheimer Disease

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesDementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Tim Gilbert, M.D.

    Pennington Biomedical Research Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tim Gilbert, M.D.

CONTACT

2257632584Tim.Gilbert@pbrc.edu

Candida Rebello, Ph.D.

CONTACT

2257633159Candida.Rebello@pbrc.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 18, 2025

First Posted

December 4, 2025

Study Start

December 1, 2025

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 1, 2027

Last Updated

December 4, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)