NCT07135245 · Phase 2 · NOT YET RECRUITING
Improved Treatment and Monitoring of Alzheimer's Disease
This trial is testing whether semaglutide (Rybelsus, the oral diabetes drug now being studied for brain effects) can slow cognitive decline in people already diagnosed with early Alzheimer's disease. It also tests semaglutide combined with other interventions including candesartan, a probiotic, and vitamins. This is a Phase 2 trial, meaning researchers are still working out whether it shows enough promise to move forward — it is not a proven or approved treatment.
You may qualify if
- Decreased cognitive abilities corresponding to 16-25 points in the Mini Mental State Examination (MMSE)
- The cognitive impairment must be supported by the presence of specific levels in cerebrospinal fluid (CSF) of β-Amyloid1-42 (≤1030 pg/ml) and Tau (total and phosphorylated, respectively over 300 pg/ml and 27 pg/ml)
- MRI scan of the brain with coronal sections showing substance loss (atrophy) of the medial part of the temporal lobe compatible with Alzheimer's disease
- PET scan of the brain (18F-FDG PET) with decreased regional glucose metabolism in the temporal and parietal regions and PiB (PiB-PET scan) with amyloid plaques in the brain compatible with Alzheimer's disease
You're excluded if
- Patients with active cancer, and in chemo- or radiation therapy
- Severe cardiovascular disease.
- Hepatic insufficiency with ASAT> 2 x upper limit of normal or renal insufficiency with serum creatinine > 200 micromol/l
- Severe epilepsy with frequent tonic-clonic (grand mal) seizures
- Insulin treatment (type 1 diabetes mellitus) and diabetic ketoacidosis
- Severe chronic disease (e.g., cirrhosis, AIDS, chronic kidney failure)
- Severe mental illness e.g., schizophrenia, or physical disabilities leading to inability to participate in intervention or tests, or to provide informed consent
- Evidence for other primary causes of neurodegeneration or dementia, e.g., significant cerebrovascular disease (whose primary cause of dementia was vascular in origin), Lewy Body disease, Parkinson's disease, Fronto-temporal dementia
- Significant ongoing psychiatric or substance abuse problems.
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2025-08-22