Health TrialsbyHealthPanel

Effect of Physiologic Insulin Administration on Insulin Sensitivity and Cognition

ConditionsAlzheimer s DiseaseAlzheimer Blood BiomarkersInsulin Sensitivity
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorPennington Biomedical Research Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Mini Mental State Examination (MMSE) score < 25

Disqualifiers

On daily medication for the specific treatment of anxiety including benzodiazepines.

An infant, child, or teenager

A pregnant woman

A prisoner

Trial design

Design model

Single group

Treatments tested in this trial

  • Physiological Insulin Intervention

    Other 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.

Treatment groups

8 Participants
are divided into 1 treatment group
Group A: Physiologic InsulinExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Over a six-month period
2

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.

Time frame
Over a six-month period
3

Insulin Sensitivity

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

Time frame
Over a six-month period

Secondary outcomes

1

Brain Glucose Uptake

We will measure brain glucose uptake using FDG-PET.

Time frame
Six months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Pennington Biomedical Research Center

Lead sponsor

Source ClinicalTrials.gov
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