Skip to main content

Table 3 Exploratory biomarker endpoints in the evoke and evoke+ trials

From: evoke and evoke+: design of two large-scale, double-blind, placebo-controlled, phase 3 studies evaluating efficacy, safety, and tolerability of semaglutide in early-stage symptomatic Alzheimer’s disease

Study

Sample type

Exploratory endpoints

Biomarker information

Time frame

Main study

Blood

Change in NfL level

Neuroaxonal damage

Baseline to week 104

Change in GFAP level

Astrogliosis

Change in p-tau181 level

Amyloid burden

CSF sub-study

CSF

Change in sTREM2 level

Neuroinflammation

Baseline to week 78

Change in MCP1/CCL2 levela

Change in YKL-40 level

Change in GFAP level

Change in IL-8 levela

Change in IL-6 levela

Change in SMOC1 levela

Change in osteopontin levela

Change in IL-1β levela

Change in IP-10/CXCL10 level

Change in IL-1 receptor antagonist levela

Change in IL-18 levela

Change in NfL level

Neurodegeneration

Change in neurogranin level

Change in total tau level

Change in amyloid β 42/40 level

Alzheimer’s disease

Change in p-tau181 level

Change in sPDGFRβ levela

Change in CSF/serum albumin ratiob

Vascular health/blood–brain barrier integrity

Change in isoprostanes levela

Change in 8-OHdG levela

Oxidative stress

Change in complement factor 3 levela

Change in complement factor 4 levela

Complement system

Semaglutide concentration in CSFa

Other

Week 78

  1. a Analysis will be performed only if a validated reliable assay is available at the end of study
  2. b Albumin will be analyzed from biochemistry samples collected for the trial
  3. 8-OHdG, 8-hydroxy-2’-deoxyguanosine; CCL2, chemokine (C-C motif) ligand 2; CSF, cerebrospinal fluid; CXCL10, C-X-C motif chemokine ligand 10; GFAP, glial fibrillary acidic protein; IL, interleukin; IP-10, interferon gamma–inducible protein-10; MCP1, monocyte chemoattractant protein 1; NfL, neurofilament light chain; p-tau181, phosphorylated tau at threonine 181; SMOC1, secreted modular calcium-binding protein 1; sPDGFRβ, soluble platelet-derived growth factor receptor beta; sTREM2, soluble triggering receptor expressed on myeloid cells 2; YKL-40, chitinase-3-like protein 1