LivingGLP1
Study S002335

A Randomised Double-blind Placebo-controlled Clinical Study Investigating the Effects of Semaglutide s.c. Once-weekly Versus Placebo on Central and Peripheral Inflammation in Participants With Alzheimer's Disease

ClinicalTrials.gov recordStudy Protocol (PDF)Statistical Analysis Plan (PDF)

Registration

Registration
NCT05891496
Study type
INTERVENTIONAL
Allocation
RANDOMIZED
Phase
PHASE3
Masking
QUADRUPLE
Status
COMPLETED
Enrollment
23
Start
2023-06-20
Primary completion
2024-08-19
Lead sponsor
Novo Nordisk A/S
Conditions
Alzheimers Disease
Interventions
DRUG:Semaglutide; DRUG:Placebo
Results posted
TRUE
Individual participant data sharing
YES
Secondary identifiers
OTHER:U1111-1283-8743; EUDRACT_NUMBER:2022-003384-24; OTHER:2023-506825-13; NIH:2023

Registered primary outcomes

  • Change in Gene Expression Assessed by Single-cell Ribonucleic Acid Sequencing (scRNAseq) (Cells in Cerebrospinal Fluid [CSF]) [Baseline (week 0), week 12]
  • Change in Gene Expression Assessed by scRNAseq (Cells in Blood) [Baseline (week 0), week 12]

Linked records (1)

Automatic links, confirmed or rejected during screening. A record citing this registration may be a secondary analysis, a commentary or a review that mentions the trial.
RecordTitleYearDesignIdentifiersLink basis
R0018118Investigating the effects of semaglutide in early Alzheimer’s disease using single‐cell transcriptomics and proteomics – rationale and design
Johannsen P, Alzheimer's & dementia : the journal of the Alzheimer's Association
2024ProtocolDOIcites ClinicalTrials.gov:NCT05891496