Company: APM
Filing Date: 2025-12-05
Form Type: 424B5
Source: 0001213900-25-118752
Chunk: 298

Company: Aptorum Group Ltd
Filing Date: 2025-12-05
Form: 424B5
Chunk 298
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 evaluated for Alzheimer’s disease and other causes of cognitive decline. The test, intended for use in adult patients aged 50 years and older presenting at a specialized care setting with signs and symptoms of cognitive decline, is the first FDA cleared blood-based IVD test in the U.S. to aid to identify patients with amyloid pathology associated with AD.

Currently it is accepted that
AD dementia is preceded by 10-20 years of the disease development, initially without clinical symptoms (pre-symptomatic AD),
and then eventually manifested as MCI, followed by onset of dementia and clinical AD symptoms. Notably, detailed analyses of failed clinical
trials suggest a therapeutic benefit in the sub-groups of patients with mild and moderate AD, a thesis validated by the lecanemab approval.
Thus, there is a significant need for the development of new methods for early AD detection.

The urgent need to address
AD epidemics has been recognized by the US Congress. “National Alzheimer’s Project Act” (NAPA) has been signed into
law in 2011. As the result of the increased congressional funding, NIH spending on Alzheimer’s and related dementias research rose
more than six-fold since 2015, reaching $3.87 billion requested for FY2024 ($321 million increase over previous year).

Current NIH budget proposal
(nia.nih.gov/research/blog/2022/07/looking-forward-nihs-alzheimers-disease-and-related-dementias-fy-2024-bypass) describes prospective
research opportunities organized in six broad categories, including: Diagnosis, Assessment, & Disease Monitoring: developing
the next generation of biomarkers to enable detection and diagnosis even earlier than is now possible and to distinguish different forms
of dementia from one another, as well as to leverage technologies that enable characterization of individual cells to advance dementia
research.

Since cognitive testing cannot
reliably identify patients in pre-symptomatic stages of AD, effective biomarkers are necessary for successful patient enrollment and treatment
monitoring.

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The pathology of AD is characterized
by neuronal death in several specific regions of the brain, including the hippocampus and cortex. However, the neuronal loss is a relatively
late event in the disease progression and is typically preceded by metabolic changes, including formation of beta-amyloid plaques and
tau protein tangles, synaptic dysfunction, synaptic loss, neurite retraction, and the appearance of other abnormalities, such as axonal
transport defects. Figure