LivingGLP1
Study S000766

Combination of Intranasal Insulin With Oral Semaglutide to Improve Cognition and Cerebral Blood Flow: a Feasibility Study

ClinicalTrials.gov record

Registration

Registration
NCT06072963
Study type
INTERVENTIONAL
Allocation
RANDOMIZED
Phase
PHASE2
Masking
QUADRUPLE
Status
RECRUITING
Enrollment
80
Start
2024-01-30
Primary completion
2027-12-01
Lead sponsor
Rutgers, The State University of New Jersey
Conditions
Alzheimer Disease; Mild Cognitive Impairment; Metabolic Syndrome
Interventions
DRUG:Semaglutide; DRUG:Intranasal insulin; OTHER:Semaglutide placebo; OTHER:Intranasal insulin placebo
Results posted
FALSE
Individual participant data sharing
NO

Registered primary outcomes

  • Cognitive change - The effect of the combination of Semaglutide and intranasal insulin on cognitive functioning. [12 months]
  • Neuroimaging outcome -- The effect of the combination of Semaglutide and intranasal insulin on cerebral blood flow (CBF). [6 months]
  • Neuroimaging outcome -- The effect of the combination of Semaglutide and intranasal insulin on brain glucose intake. [6 months]

Linked records (11)

Automatic links, confirmed or rejected during screening. A record citing this registration may be a secondary analysis, a commentary or a review that mentions the trial.
RecordTitleYearDesignIdentifiersLink basis
R0015557Efficacy and safety of oral semaglutide in type 2 diabetes mellitus: A systematic review and meta-analysis.
Li A, Diabetes research and clinical practice
2023Systematic reviewPMID 36871874DOIregistry reference BACKGROUND:36871874
R0007621Safety of Semaglutide.
Smits MM, Frontiers in endocrinology
2021Nonrandomized studyPMID 34305810DOIregistry reference BACKGROUND:34305810
R0019259Semaglutide-mediated protection against Aβ correlated with enhancement of autophagy and inhibition of apotosis.
Chang YF, Journal of clinical neuroscience : official journal of the Neurosurgical Society of Australasia
2020Other trialPMID 33222922DOIregistry reference BACKGROUND:33222922
R0020309Effect of dulaglutide on cognitive impairment in type 2 diabetes: an exploratory analysis of the REWIND trial.
Cukierman-Yaffe T, The Lancet. Neurology
2020Randomized trialPMID 32562683DOIregistry reference BACKGROUND:32562683
R0021071The effect of dulaglutide on stroke: an exploratory analysis of the REWIND trial.
Gerstein HC, The lancet. Diabetes & endocrinology
2020Randomized trialPMID 31924562DOIregistry reference BACKGROUND:31924562
R0017419Evaluating the effects of the novel GLP-1 analogue liraglutide in Alzheimer's disease: study protocol for a randomised controlled trial (ELAD study).
Femminella GD, Trials
2019ProtocolPMID 30944040DOIregistry reference BACKGROUND:30944040
R0017546Combination of Insulin with a GLP1 Agonist Is Associated with Better Memory and Normal Expression of Insulin Receptor Pathway Genes in a Mouse Model of Alzheimer's Disease.
Robinson A, Journal of molecular neuroscience : MN
2019PreclinicalPMID 30635783DOIregistry reference BACKGROUND:30635783
R0018537Dulaglutide and cardiovascular outcomes in type 2 diabetes (REWIND): a double-blind, randomised placebo-controlled trial.
Gerstein HC, Lancet (London, England)
2019Randomized trialPMID 31189511DOIregistry reference BACKGROUND:31189511
R0022511Semaglutide as a therapeutic option for elderly patients with type 2 diabetes: Pooled analysis of the SUSTAIN 1-5 trials.
Warren M, Diabetes, obesity & metabolism
2018Randomized trialPMID 29687620DOIregistry reference BACKGROUND:29687620
R0021844Glucagon-like peptide 1 (GLP-1) analogue combined with insulin reduces HbA1c and weight with low risk of hypoglycemia and high treatment satisfaction.
Lind M, Primary care diabetes
2012OtherPMID 22015237DOIregistry reference BACKGROUND:22015237
R0025044Distribution of GLP-1 binding sites in the rat brain: evidence that exendin-4 is a ligand of brain GLP-1 binding sites.
Göke R, The European journal of neuroscience
1995PreclinicalPMID 8563978DOIregistry reference BACKGROUND:8563978