Alzheimer Blood Biomarkers, Alzheimer s Disease, Insulin Sensitivity
Conditions
Keywords
Alzheimer's disease, Insulin Sensitivity
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.
Interventions
OTHERPhysiological 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.
Sponsors
Pennington Biomedical Research Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cognition | 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. |
| Insulin Sensitivity | Over a six-month period | Insulin sensitivity (glucose disposal rate measured during a hyperinsulinemic euglycemic clamp) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Brain Glucose Uptake | Six months | We will measure brain glucose uptake using FDG-PET. |
Countries
United States
Contacts
Primary ContactTim Gilbert, M.D.
Backup ContactCandida Rebello, Ph.D.
Outcome results
None listed