Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06363487
Status:
RECRUITING
Last Update Posted:
2024-06-21
First Post:
2024-04-09
Brief Title:
Semaglutide and Cognition in Healthy Volunteers
Sponsor:
University of Oxford
Organization:
University of Oxford
Study Overview
Official Title:
Effects of Single-dose Semaglutide on Cognition and Energy in Healthy Volunteers
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OxSENSE
Brief Summary:
Semaglutide is a glucagon-like peptide 1 receptor agonist GLP-1RA It is a safe medication approved for use in type-2 diabetes mellitus T2DM and obesity Primarily it works by counteracting insulin-resistance and inducing weight loss It also acts on several other interconnected neurobiological immunological esp inflammatory endocrine-metabolic and gut-brain axis processes that play a role in depressive symptoms Its effects on cognition and energy are currently unknown In this study we are using semaglutide as an experimental tool to further investigate these relationships
Detailed Description:
Semaglutide is a novel GLP-1RA licensed for T2DM and obesity which mainly works by offsetting insulin-resistance and stimulating weight loss 1 It also acts on various neurobiological immunological endocrine-metabolic and gut-brain axis processes that play a role in depressive symptoms 2 Preliminary evidence suggests these drugs are safe from a neuropsychiatric perspective 3 and could be beneficial in unipolar 4 and bipolar depression 5 - an outcome possibly mediated by inflammatory pathways 6
The proposed study investigates the effects of semaglutide on cognition and energy which are currently unknown Work in our laboratory established that short-term use of conventional antidepressants in healthy volunteers shifts reward sensitivity and emotional cognition 7 - an important neuropsychological mechanism of antidepressant action 8 An experimental medicine trial that assesses the effects of semaglutide on reward sensitivity emotional cognition can validate its potential to be repurposed for treating depressive disorders 9 Moreover brain insulin resistance likely lessened by semaglutide is associated with deficit in impulse-control as well as non-emotional cognitive and energy impairment in people with depression 10 Finally defining the overall cognitive and energy profile of semaglutide is important for the many people already taking it for its licensed indications ie T2DM obesity
Therefore the primary objective of this study is to assess the effect of a single dose of semaglutide 05mg subcutaneous injection vs placebo on reward sensitivity tasks in healthy volunteers Secondary objectives include the investigation of the effects of semaglutide on other cognitive domains emotional processing impulsivity memory and energyactivity levels Psychological questionnaires are also measured as relevant covariates
The proposed study investigates the effects of semaglutide on cognition and energy which are currently unknown Work in our laboratory established that short-term use of conventional antidepressants in healthy volunteers shifts reward sensitivity and emotional cognition 7 - an important neuropsychological mechanism of antidepressant action 8 An experimental medicine trial that assesses the effects of semaglutide on reward sensitivity emotional cognition can validate its potential to be repurposed for treating depressive disorders 9 Moreover brain insulin resistance likely lessened by semaglutide is associated with deficit in impulse-control as well as non-emotional cognitive and energy impairment in people with depression 10 Finally defining the overall cognitive and energy profile of semaglutide is important for the many people already taking it for its licensed indications ie T2DM obesity
Therefore the primary objective of this study is to assess the effect of a single dose of semaglutide 05mg subcutaneous injection vs placebo on reward sensitivity tasks in healthy volunteers Secondary objectives include the investigation of the effects of semaglutide on other cognitive domains emotional processing impulsivity memory and energyactivity levels Psychological questionnaires are also measured as relevant covariates
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None