ClinicalTrials.gov recorded primary completion on 2024-08-19 for a completed phase 3 study of semaglutide in people with Alzheimer’s disease. The trial enrolled 23 participants and compared semaglutide with placebo, reporting gene-expression measurements in cerebrospinal-fluid and blood cells, along with treatment-emergent adverse events.
Background
The study examined whether semaglutide could affect the immune system and other biological processes in people with Alzheimer’s disease. The trial record describes semaglutide as a medicine that doctors can prescribe in some countries for type 2 diabetes and excess body weight. The study was intended to help assess whether semaglutide could also be used for Alzheimer’s disease.
Trial design
This was a completed phase 3 study listed under Alzheimer’s disease. It enrolled 23 participants and included semaglutide and placebo intervention groups. The study was planned to last about 77 weeks, with participants receiving semaglutide or placebo during the first 12 weeks of treatment. The supplied record listed no primary outcome measurements.
Key results
For change in gene expression measured by single-cell RNA sequencing in cerebrospinal-fluid cells, the semaglutide group had a mean of 41.25 differentially expressed genes, with a standard deviation of 29.68. The placebo group had a mean of 21.00 differentially expressed genes, with a standard deviation of 25.70.
For change in gene expression measured in blood cells, the semaglutide group had a mean of 10.00 differentially expressed genes and a standard deviation of 5.97. The placebo group had a mean of 16.50 differentially expressed genes and a standard deviation of 15.86.
The record reported 31 treatment-emergent adverse events in the semaglutide group and 8 events in the placebo group. No p-values, confidence intervals, or adverse-event summary were supplied in the data.
What this means
The completed study provides group-level measurements on gene-expression changes in cerebrospinal-fluid and blood cells, plus counts of treatment-emergent adverse events. The cerebrospinal-fluid measurement was higher with semaglutide than placebo, while the blood-cell measurement was lower. These posted data do not establish comparative efficacy or safety because no primary outcome results, statistical analyses, p-values, or confidence intervals were provided.
Source
This article is based on results posted by ClinicalTrials.gov on 2024-08-19. The source document is the ClinicalTrials.gov study record for NCT05891496, available at clinicaltrials.gov.