Company: APM
Filing Date: 2025-07-15
Form Type: DRS
Source: 0001213900-25-063899
Chunk: 288

Company: Aptorum Group Ltd
Filing Date: 2025-07-15
Form: DRS
Chunk 288
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 brain-enriched
microRNAs as biomarkers for Rett Syndrome.

The goal of this study was to assess brain-enriched
microRNA biomarkers in plasma samples of Mecp2 deficient male and female mice and controls.

NIH/NIA SBIR Phase I Grant Number 1R43AG044860-01
07/01/2013-12/31/2013

Title: Early detection of Alzheimer’s disease
at MCI stage by analysis of cell-free miRNA in plasma.

The goal of this study was to assess feasibility
of detecting MCI patients who would progress to AD dementia and to identify microRNA biomarker candidates for differentiating Alzheimer’s
disease from Parkinson’s disease.

The Michael J. Fox Foundation for Parkinson’s
Research Grant Number 9477 2014

Title: Analysis of circulating brain-enriched
microRNAs as biomarkers for Parkinson’s disease.

The goal of this study was to test microRNA biomarker
candidates using plasma samples collected from Parkinson’s disease patients and age-matched controls from the BioFIND clinical study.

IRS-QTDP 2011

Title: Development of ADmiR, molecular test for
early detection and monitoring of Alzheimer’s Disease.

Early studies towards identification of microRNA
biomarker candidates for Alzheimer’s Disease.

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Research & Development Strategy

DiamiR intends to conduct clinical development
and launch CogniMIR as a Laboratory Developed Test (LDT) using its CLIA-certified, CAP accredited laboratory based in
New Haven CT.

According to the FDA’s guidance, “a
laboratory developed test (LDT) is a type of in vitro diagnostic test that is designed, manufactured and used within a single laboratory.
LDTs can be used to measure or detect a wide variety of analytes (substances such as proteins, chemical compounds like glucose or cholesterol,
or DNA), in a sample taken from a human body. Some LDTs are relatively simple tests that measure single analytes, such as a test that
measures the level of sodium. Other LDTs are complex and may measure or detect one or more analytes. For example, some tests can detect
many DNA variations from a single blood sample, which can be used to help diagnose a genetic disease. Various levels of chemicals can
be measured to help diagnose a patient’s state of health, such as levels of cholesterol or sodium. While the uses of an L