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| ID | Type | Description | Link |
|---|---|---|---|
| PBRC Foundation funds | Other Identifier | Pennington Biomedical Research Foundation |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Physiological Insulin Intervention | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Brain Glucose Uptake | We will measure brain glucose uptake using FDG-PET. | Six months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tim Gilbert, M.D. | Contact | 2257632584 | Tim.Gilbert@pbrc.edu | |
| Candida Rebello, Ph.D. | Contact | 2257633159 | Candida.Rebello@pbrc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Tim Gilbert, M.D. | Pennington Biomedical Research Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pennington Biomedical Research Center | Recruiting | Baton Rouge | Louisiana | 70806 | United States |
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| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |