The study is being conducted to understand how the medicine, semaglutide, affects the immune system and other biological processes in people with Alzheimer's disease. Semaglutide is a medicine that doctors can prescribe in some countries for the treatment of type 2 diabetes and excess body weight. This study will help us understand whether semaglutide can also be used for the treatment of Alzheimer's disease. The study will last for about 77 weeks. In the first 12 weeks of treatment, participants will either get semaglutide (active medicine) or placebo (inactive dummy medicine). Which treatment participants get is decided by chance. In the following 52 weeks of treatment, all participants taking part in the study will get semaglutide. Participants must have a study partner, who is willing to take part in the study. Participants will get study medicine in a pen injector. The study partner will need to inject the study medicine into the skin of participant's stomach, thigh or upper arm once every week.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
23
Semagllutide will be administered once weekly subcutaneously.
Placebo matched to semaglutide will be administered once weekly subcutaneously.
Banner Sun Health Research Institute
Sun City, Arizona, United States
Brain Matters Research
Delray Beach, Florida, United States
Ottawa Memory Clinic
Ottawa, Ontario, Canada
Memory Program
Toronto, Ontario, Canada
Rigshospitalet - afsnit 8015 Hukommelsesklinikken
København Ø, Denmark
Rigshospitalet - afsnit 8015
København Ø, Denmark
Azienda Ospedaliera Spedali Civili di Brescia
Brescia, Italy
Azienda Ospedaliera di Perugia;Ospedale S. Maria della Misericordia
Perugia, Italy
Azienda Ospedaliera di Perugia;Ospedale S. Maria della Miser
Perugia, Italy
Fondazione Santa Lucia IRCCS
Roma, Italy
...and 2 more locations
Change in Gene Expression Assessed by Single-cell Ribonucleic Acid Sequencing (scRNAseq) (Cells in Cerebrospinal Fluid [CSF])
Change in gene expression assessed by scRNAseq (cells in CSF) from baseline (week 0) to week 12 is presented. Change in gene expression is presented as the mean number of differentially expressed genes (DEG).
Time frame: Baseline (week 0), week 12
Change in Gene Expression Assessed by scRNAseq (Cells in Blood)
Change in gene expression assessed by scRNAseq (cells in blood) from baseline (week 0) to week 12 is presented. Change in gene expression is presented as the mean number of differentially expressed genes.
Time frame: Baseline (week 0), week 12
Number of Treatment Emergent Adverse Events (TEAEs)
An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant that is temporally associated with the use of investigational medicinal product (IMP), whether or not considered related to the IMP. All AEs mentioned here are treatment emergent adverse events (TEAE) defined as an event with onset during the on-treatment period.
Time frame: From baseline (week 0) to week 12
Number of TEAEs
Time frame: From baseline (week 0) to week 64
Weekly Average Semaglutide Concentration [Average Concentration (Cavg)] Based on Population Pharmacokinetics (PK) Analysis
Time frame: From week 4 to week 64
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