NCT07200622Not yet recruitingPhase 2
Oral Semaglutide in Patients With Alzheimer's Disease
Evaluating the Effects of GLP-1 Analogue, Oral Semaglutide, in Patients With Alzheimer's Disease
Source: ClinicalTrials.gov · Last updated 1 Oct 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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 therapy (DMT) that may slow the disease progression, and prevent cognitive and functional deterioration, is yet to emerge. Glucagon-like peptide-1 (GLP-1) analogues are being studied to treat neurodegenerative diseases, due to evidence of their neuroprotective effects in mouse models of AD. This study investigates Semaglutide, a modified human GLP-1RA in Alzheimer's disease to understand the mechanism of the disease. The primary objective of this study is to evaluate the safety and tolerability of oral semaglutide in individuals with mild AD. Moreover, the secondary objective of the study is to evaluate the change in synaptic density using PET before and after treatment with semaglutide.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 18 Sept 2025
- Start date
- 25 Sept 2025
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Imperial College London
- Diseases
- Alzheimer disease
- NCT number
- NCT07200622
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 60
- From 25 Sept 2025 to the primary completion date, 31 Dec 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current use of narcotic medications which could affect cognition. Subjects on anticoagulants will be allowed, but will not have an arterial line inserted
Other illness
- 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
- History of alcohol or drug dependence within the last 2 years
- History of medullary thyroid cancer
Lab values
- Other clinically significant abnormality on physical, neurological or laboratory examination that could compromise the study or be detrimental to the subject
Other
- Any contraindications to the use of oral semaglutide
- 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.
- Patients diagnosed with T2DM who are unwilling to change their treatment to semaglutide.
Who the study is looking for
- 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
Age in the registry: 50 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.