ApoE Testing
Inheritance of the ε4 allele of the Apolipoprotein (APO) E gene is the strongest genetic risk factor for late-onset AD.” 1
With the recent FDA approval of Kisunla2 and Leqembi,3 research into anti-amyloid antibodies is at an all-time high and requires an understanding of ApoE genotype. The Genomadix Cube ApoE Test (RUO) can help.
By 2060, the number of people age 65 and older with Alzheimer’s dementia is projected to reach 13.8 million, barring the development of medical breakthroughs to prevent, slow or cure Alzheimer’s disease.” 4
“In 2022, an estimated 6.5 million Americans age 65 and older are living with Alzheimer’s dementia and the total national cost of caring for people living with Alzheimer’s and other dementias is projected to reach $321 billion.” 5
“Patients treated with Leqembi who are homozygous for the ApoE ε4 allele have a higher incidence of ARIA, including symptomatic, serious and severe ARIA, compared to heterozygotes and noncarriers. The prescribing information states that testing for ApoE ε4 status should be performed before starting treatment with Leqembi to inform the risk of developing ARIA.”3
ApoE And It’s Role In AD
“Inheritance of the ε4 allele of the Apolipoprotein (APO) E gene is the strongest genetic risk factor for late-onset AD.” 1
“Alzheimer’s Disease is the only major cause of death without any effective pharmacological means to treat or slow progression.” 6
“Apolipoprotein E4 (ApoE 4), the most prevalent genetic risk factor of AD, is expressed in more than half of AD patients and is thus an important possible AD therapeutic target.” 7
“The ApoE ε4 allele remains the strongest genetic risk factor for sporadic Alzheimer’s disease … However, no therapies directed at ApoE are currently available.” 8
“AD diagnosis has shifted from syndromal, based on signs and symptoms, to a biomarker construct based on the pathological hallmarks of the disease: amyloid β deposition, pathologic tau, and neurodegeneration.” 6
“Researchers have long posited that pharmacologic treatments, or medications, aimed at slowing or stopping the progression of Alzheimer’s disease to dementia and preserving brain function are most effective when administered early in the disease process.” 9
“The road to the discovery of effective AD therapies has been marked by a long string of failures, at least in part, due to relatively few investigators directly targeting the critical role of ApoE in AD.” 1
55.8% of Alzheimer’s Disease patients in the US are carriers of ApoE E4.10
11.5% of Alzheimer’s Disease patients in the U.S. are homozygous ApoE E4/E4 genotype.10
Promising AD Therapeutic Target
“Despite the enormous amounts of resources and efforts for AD drug development during the last three decades, no effective treatments have been developed that can slow or halt the progression of the disease.” 11
“ApoE ε4 is a promising AD therapeutic target, that remains understudied. With recent studies are now paving the way for effective ApoE ε4-directed AD treatment approaches.” 7
“From a recent study by Alzheimer’s Org – in 2020 the number of Americans over the age of 65 with Alzheimer’s was 6.1 million and it is projected to increase to 11.2 million in 2040. ” 4
How Genomadix Can Help
- “Low participation in clinical trials is a major challenge to advancing clinical AD research and care.” 12
- “The success of randomized controlled trials (RCTs) relies on adequate and timely recruitment.” 12
Genomadix is developing the Cube ApoE genotyping test towards a full IVD (CE Mark and 510(k)). If you are interested in the Genomadix Cube ApoE Test (RUO), please contact us.
Alzheimer's Association -
Earlier Diagnosis
Alzheimer's Association - TrialMatch: Find Clinical Trials for Alzheimer's and Other Dementia
2024 Alzheimer's
Disease Facts and Figures
REFERENCES
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Wisniewski T, Drummond E. ApoE -amyloid interaction: Therapeutic targets. Neurobiol Dis. 2020 May;138:104784. doi: 10.1016/j.nbd.2020.104784. Epub 2020 Feb 4. PMID: 32027932; PMCID: PMC7118587.
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Eli Lilly and Company. 2024. Lilly’s Kisunla™ (donanemab-azbt) Approved by the FDA for the Treatment of Early Symptomatic Alzheimer’s Disease. [online] Available at: <https://investor.lilly.com/news-releases/news-release-details/lillys-kisunlatm-donanemab-azbt-approved-fda-treatment-early>[Accessed 10 September 2024]
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FDA. 2023. FDA Converts Novel Alzheimer’s Disease Treatment to Traditional Approval. [online] Available at: <https://www.fda.gov/news-events/press-announcements/fda-converts-novel-alzheimers-disease-treatment-traditional-approval>[Accessed 10 September 2024]
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Alz.org. 2023. 2023 Alzheimer’s Disease Facts and Figures. [online] Available at: <https://www.alz.org/media/Documents/alzheimers-facts-and-figures-2023.pdf> [Accessed 11 September 2024].
-
Alz.org. 2022. 2022 Alzheimer’s Disease Facts and Figures. [online] Available at: <https://www.alz.org/media/Documents/alzheimers-facts-and-figures-2022.pdf> [Accessed 27 July 2022].
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van Bokhoven, P., de Wilde, A., Vermunt, L. et al. The Alzheimer’s disease drug development landscape. Alz Res Therapy 13, 186 (2021). https://doi.org/10.1186/s13195-021-00927-z
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Safieh, M., Korczyn, A.D. & Michaelson, D.M. ApoE4: an emerging therapeutic target for Alzheimer’s disease. BMC Med 17, 64 (2019). https://doi.org/10.1186/s12916-019-1299-4
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Serrano-Pozo A, Das S, Hyman BT. ApoE and Alzheimer’s disease: advances in genetics, pathophysiology, and therapeutic approaches. Lancet Neurol. 2021 Jan;20(1):68-80. doi: 10.1016/S1474-4422(20)30412-9. Erratum in: Lancet Neurol. 2021 Feb;20(2):e2. PMID: 33340485; PMCID: PMC8096522.
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Alz.org. 2022. 2022 Alzheimer’s Disease Facts and Figures Special Report. [online] Available at: <https://www.alz.org/media/Documents/alzheimers-facts-and-figures-special-report-2022.pdf> [Accessed 11 September 2024]
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Ward et al. Prevalence of Apolipoprotein E4 Genotype and Homozygotes (ApoE e4/4) among Patients Diagnosed with Alzheimer’s Disease: A Systematic Review and Meta-Analysis Neuroepidemiology 2012;38:1–17 https://doi.org/10.1159/000334607
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Gong CX, Dai CL, Liu F, Iqbal K. Multi-Targets: An Unconventional Drug Development Strategy for Alzheimer’s Disease. Front Aging Neurosci. 2022 Feb 9;14:837649. doi: 10.3389/fnagi.2022.837649. PMID: 35222001; PMCID: PMC8864545.
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Clement C, Selman LE, Kehoe PG, Howden B, Lane JA, Horwood J. Challenges to and Facilitators of Recruitment to an Alzheimer’s Disease Clinical Trial: A Qualitative Interview Study. J Alzheimers Dis. 2019;69(4):1067-1075. doi:10.3233/JAD-190146
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Belloy ME, Napolioni V, Greicius MD. A Quarter Century of ApoE and Alzheimer’s Disease: Progress to Date and the Path Forward. Neuron. 2019 Mar 6;101(5):820-838. doi: 10.1016/j.neuron.2019.01.056. PMID: 30844401; PMCID: PMC6407643.
