Status:
NOT_YET_RECRUITING
Oral Semaglutide in Patients With Alzheimer's Disease
Lead Sponsor:
Imperial College London
Conditions:
Alzheimer Disease
Eligibility:
All Genders
50+ years
Phase:
PHASE2
Brief Summary
Alzheimer's disease (AD) is a progressive neurodegenerative disease and a major global healthcare burden. Currently, the disease is only treated symptomatically and an effective disease-modifying ther...
Eligibility Criteria
Inclusion
- Capable of giving and capacity to give informed consent.
- An individual who can act as a reliable study partner with regular contact
- Diagnosis of Alzheimer's disease according to the revised NIA-AA criteria
- Age from 50 years
- Mini-Mental State Examination (MMSE) score of ≥18; likely complete all the assessments
- Rosen Modified Hachinski Ischemic score ≤4
- On stable medication for 2 months before the screening visit; on or off cholinesterase inhibitors
- Fluency in English and evidence of adequate premorbid intellectual functioning
- Likely to be able to participate in all scheduled evaluations and complete all required tests
Exclusion
- Any contraindications to the use of oral semaglutide
- Significant neurological disease other than AD that may affect cognition
- MRI/CT showing unambiguous aetiological evidence of cerebrovascular disease with regard to their dementia or vascular dementia fulfilling NINCDSAIREN criteria
- Current presence of a clinically significant major psychiatric disorder
- Current clinically significant systemic illness that is likely to result in deterioration of the subject's condition or affect the subject's safety during the study
- Myocardial infarction within the last 1 year
- Other clinically significant abnormality on physical, neurological or laboratory examination that could compromise the study or be detrimental to the subject
- History of alcohol or drug dependence within the last 2 years
- Current use of narcotic medications which could affect cognition. Subjects on anticoagulants will be allowed, but will not have an arterial line inserted
- Women of childbearing potential. Women who could become pregnant will be required to use adequate contraception throughout the trial. Please see appendix A for more information. All women of childbearing potential will take a pregnancy test before the PET scan.
- Any contraindications to MRI scanning
- Any historical evidence of pancreatitis or gallstones as proven by ultrasound or medical admission.
- History of medullary thyroid cancer
- Patients diagnosed with T2DM who are unwilling to change their treatment to semaglutide.
Key Trial Info
Start Date :
September 25 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2028
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT07200622
Start Date
September 25 2025
End Date
December 31 2028
Last Update
October 1 2025
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