Lumipulse^® G ADxPLORER^® Neurogranin

Synaptic damage is an early and essential characteristic of Alzheimer’s disease (AD)¹ and is directly related to cognitive impairment. Studies show the potential of cerebrospinal fluid (CSF) neurogranin as an AD biomarker and demonstrate a correlation between neurogranin levels and cognitive decline^2,3. In addition, several studies on amyloid immunotherapy suggest that neurogranin may have potential as an early target engagement marker^4,5,6. However, its clinical utility remains to be further established.

The Lumipulse® G ADxPLORER® Neurogranin assay was developed using two proprietary monoclonal antibodies. The ADx403 mAb (90577), which binds to a C-terminal internal epitope, is combined with an alkaline phosphatase-conjugated Fab fragment derived from the ADx451 mAb (90589), which targets specifically neurogranin truncated at P75. A synthetic peptide is used as a calibrator. C-terminally truncated neurogranin species are present in both blood and CSF. A comparative assay study in CSF suggests that three commonly used neurogranin assays provide similar diagnostic information⁷.
 

References:

1. Selkoe DJ. Alzheimer's disease is a synaptic failure. Science. 2002 Oct 25;298(5594):789-91.
2. Schipke et al. Neurogranin and BACE1 in CSF as Potential Biomarkers Differentiating Depression with Cognitive Deficits from Early Alzheimer's Disease: A Pilot Study. Dement Geriatr Cogn Dis Extra. 2018 Aug 6;8(2):277-289.
3. Kvartsberg et al. Cerebrospinal fluid levels of the synaptic protein neurogranin correlates with cognitive decline in prodromal Alzheimer's disease. Alzheimers Dement. 2015 Oct;11(10):1180-90.
4. Ostrowitzki et al. A phase III randomized trial of gantenerumab in prodromal Alzheimer's disease. Alzheimers Res Ther. 2017 Dec 8;9(1):95. doi: 10.1186/s13195-017-0318-y. Erratum in: Alzheimers Res Ther. 2018 Sep 27;10(1):99.
5. Wagemann et al. Dominantly Inherited Alzheimer Network–Trials Unit. Downstream Biomarker Effects of Gantenerumab or Solanezumab in Dominantly Inherited Alzheimer Disease: The DIAN-TU-001 Randomized Clinical Trial. JAMA Neurol. 2024 Jun 1;81(6):582-593.
6. Cline et al. Biofluid biomarker changes following treatment with sabirnetug (ACU193) in INTERCEPT-AD, a phase 1 trial in early Alzheimer's disease. J Prev Alzheimers Dis. 2025 Apr;12(4):100082. doi: 10.1016/j.tjpad.2025.100082. Epub 2025 Feb 17. Erratum in: J Prev Alzheimers Dis. 2025 Aug;12(7):100217.
7. Willemse et al. Neurogranin as Cerebrospinal Fluid Biomarker for Alzheimer Disease: An Assay Comparison Study. Clin Chem. 2018 Jun;64(6):927-937.

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ADxPLORER is a registered trademark of Fujirebio Europe NV.