Weekly physiologic insulin sessions to improve insulin sensitivity and memory in Alzheimer’s
Effect of Physiologic Insulin Intervention on Insulin Sensitivity and Cognition
This trial will test whether weekly short (up to two-hour) physiologic insulin sessions can improve how the body uses glucose and help thinking and memory in adults with Alzheimer’s disease.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 8 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Pennington Biomedical Research Center Academic / other |
| Locations | 1 site (Baton Rouge, Louisiana) |
| Trial ID | NCT07265323 on ClinicalTrials.gov |
What this trial studies
Adults with Alzheimer’s disease will receive a physiologic insulin intervention once a week for six months, with each session lasting up to two hours. Participants will have measures of insulin sensitivity, cognitive testing including the MoCA and the RMBPC, and brain glucose uptake measured by FDG-PET before and after the intervention. Adverse events and feasibility will be tracked throughout the study to determine safety and tolerability. The trial enrolls adults with MMSE scores below 25 and excludes those taking daily benzodiazepines, pregnant women, prisoners, and others judged unsuitable by the investigative team.
Who should consider this trial
Good fit: Ideal candidates are adults with Alzheimer’s disease who have an MMSE score below 25, can attend weekly visits at the Baton Rouge site, and are not pregnant or taking daily benzodiazepines.
Not a fit: People without impaired insulin sensitivity, those with severe medical conditions that prevent safe insulin administration, or those unable to attend weekly visits are unlikely to gain benefit from this intervention.
Why it matters
Potential benefit: If successful, this approach could improve insulin sensitivity and produce measurable gains in thinking and memory for some people with Alzheimer’s.
How similar studies have performed: Prior studies of insulin for cognition, including intranasal insulin trials, have shown mixed results and this specific weekly physiologic infusion approach is largely novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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).
Where this trial is running
Baton Rouge, Louisiana
- Pennington Biomedical Research Center — Baton Rouge, Louisiana, United States (Recruiting)
Study contacts
- Principal investigator: Tim Gilbert, M.D. — Pennington Biomedical Research Center
- Study coordinator: Tim Gilbert, M.D.
- Email: Tim.Gilbert@pbrc.edu
- Phone: 2257632584
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.