Improved Treatment and Monitoring of Alzheimer's Disease
- Status
- Not yet recruitingResults none
- Why it is watched
- non-weight indication: cognition, alzheimers
- Who it enrolls
- excludes diabetes; no BMI minimum stated; conditions: Alzheimer Disease (AD)
- Interventions
- Semaglutide (Rybelsus®) combined with other interventions; Placebo; Semaglutide (Rybelsus®)
- Conditions
- Alzheimer Disease (AD)
- Phase and size
- Phase 2 · 180 participants
- Dates
- Start 2026-01-01
Primary completion 2030-09-30 - Sponsor
- Rune Skovgaard Rasmussen (Other)
- Last checked
- Sep 13, 2026
01Endpoints
What the trial will measure
- The Montreal Cognitive AssessmentAt inclusion, and 52 and 78 weeks.
02Eligibility
Who can take part
Inclusion Criteria: * 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 Exclusion Criteria: * 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.
03Change log
Registry changes
No changes recorded since the trial was added.