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

Status: Recruiting
Location: See location...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

The investigators propose a proof of concept RCT (randomized clinical trial), testing the efficacy of intranasal insulin (INI) with semaglutide, a combination therapy with strong biological plausibility to benefit impaired cognition through vascular mechanisms, in older adults with MetS (metabolic syndrome) and MCI (Mild Cognitive Impairment), who are enriched for cerebrovascular disease and at high dementia risk. The study will focus on cognitive and biological outcomes, allowing identification of relevant mechanisms.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 60
Maximum Age: 90
Healthy Volunteers: f
View:

• Diagnosis of MCI (based on a MOCA \<27 and a clinical dementia rating scale \[CDR\] score of 0.5 representing questionable dementia).

• Diagnosis of MetS -requiring a) abdominal obesity (waist circumference \>102cm for men and \>88cm for women), and b) glucose intolerance (fasting glucose\>110 mg/dL) and at least one of the following-c) dyslipidemia (high triglycerides \[\>150 mg/dL\] and low HDL \[\<40mg/dL for men and \<50 mg/dL for women\]), or d) elevated blood pressure (\>130/\>85 mmHg).

• Fluent in Hebrew

• The study requires an active study partner

Locations
Other Locations
Israel
Joseph Sagol Neuroscience center, Sheba Medical Center
RECRUITING
Ramat Gan
Contact Information
Primary
Iscka Yore
Iscka.Yore@sheba.health.gov.il
+972-35307262
Backup
Tal Niv
Tal.Niv@sheba.health.gov.il
+972-35305406
Time Frame
Start Date: 2024-01-30
Estimated Completion Date: 2028-12-01
Participants
Target number of participants: 80
Treatments
Experimental: Group 1
Will receive intranasal insulin therapy as well as Oral Semaglutide.
Sham_comparator: Group 2
Will receive active intranasal insulin therapy and placebo Oral Semaglutide.
Sham_comparator: Group 3
Will receive intranasal insulin placebo and active Oral Semaglutide .
Placebo_comparator: Group 4
Will receive intranasal insulin placebo and Oral Semaglutide placebo.
Sponsors
Collaborators: Alzheimer's Association
Leads: Rutgers, The State University of New Jersey

This content was sourced from clinicaltrials.gov