This phase II trial tests the impact of liraglutide on cognitive performance in obese patients with multiple sclerosis, acute leukemia or long-COVID that have cognitive and mental performance problems. Liraglutide, a weight loss drug, belongs to a class of medications called glucagon‐like peptide‐1 (GLP‐1) receptor agonists and may help regulate brain-derived neurotrophic factor (BDNF) levels, which can be linked to issues with cognitive and mental performance. Liraglutide may improve cognitive performance in obese patients with multiple sclerosis, acute leukemia or long-COVID.
Additional locations may be listed on ClinicalTrials.gov for NCT06171152.
Locations matching your search criteria
United States
Illinois
Chicago
University of Chicago Comprehensive Cancer CenterStatus: Active
Contact: Adam DuVall
Phone: 773-702-8951
PRIMARY OBJECTIVE:
I. Change from baseline in serum brain derived neurotrophic factor (BDNF) levels after reaching the goal dose of GLP-1 agonist (8 weeks).
SECONDARY OBJECTIVE:
I. Change from baseline in serum BDNF levels at 4 weeks, 12 weeks, and after discontinuing study drug.
EXPLORATORY OBJECTIVES:
I. Change in National Institutes of Health (NIH) Toolbox functional cognitive tests over time.
II. Change in Patient-Reported Outcomes Measurement Information System 29-item Profile (PROMIS-29) over time.
III. Change in Quality of Life in Neurological Disorders (Neuro-QoL) cognitive measurements over time.
IV. Examine the inflammatory milieu at baseline in each individual over time using an established inflammatory and neurotrophic factor multiplex assay with 76 targets curated for inflammatory and neurodegenerative disease.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive regimen A liraglutide subcutaneously (SC) once daily (QD) on days 1-7 weekly for up to 12 weeks in the absence of unacceptable toxicity. Patients also undergo blood sample collection on study.
ARM II: Patients receive regimen B liraglutide SC QD on days 1-7 weekly for up to 12 weeks in the absence of unacceptable toxicity. Patients also undergo blood sample collection on study.
After completion of study treatment, patients are followed up for up to 8 weeks.
Lead OrganizationUniversity of Chicago Comprehensive Cancer Center
Principal InvestigatorAdam DuVall