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    Home > Active Ingredient News > Study of Nervous System > Express Can Alzheimer's disease be treated without taking medicine? The innovative therapy has been recognized by the US FDA and will start key clinical trials next year

    Express Can Alzheimer's disease be treated without taking medicine? The innovative therapy has been recognized by the US FDA and will start key clinical trials next year

    • Last Update: 2022-10-25
    • Source: Internet
    • Author: User
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    ▎WuXi AppTec content team editor

    Sinaptica Therapeutics today announced that the U.
    S.
    FDA has granted its SinaptiStim – AD System Breakthrough Medical Device Designation (BDD) for the treatment of cognitive and functional decline
    in Alzheimer's patients.
    This innovative electromagnetic wave therapy, which combines neurostimulation, brain wave detection, artificial intelligence and other technologies, has the potential to revolutionize the treatment of Alzheimer's disease, allowing patients to improve
    their dementia symptoms without taking medication.
    Sinaptica expects to initiate pivotal clinical trials
    next year.



    Alzheimer's disease is a neurodegenerative disease
    primarily associated with aging.
    It is estimated that by the age of 80, one in three people will be diagnosed with Alzheimer's disease
    .
    Alzheimer's disease progresses to changes in thinking, memory and behavior, and the disease eventually progresses to dementia within a few years
    .
    There are many causes of Alzheimer's disease, but Alzheimer's disease is the most common
    .
    Alzheimer's disease is not a normal aging process, and complex changes occur in the patient's brain 20 years before symptoms begin, eventually leading to brain cell death or loss
    of bonds.
    There are currently about 50 million Alzheimer's patients worldwide, and as the world's population ages, it is estimated that the number of Alzheimer's patients will almost triple to 140 million by 2060
    .
    Genetic and environmental factors influence the development and progression
    of the disease.



    Synaptic plasticity, the adjustable strength of connections between nerve cells, is the basis for learning and memory, and its variation is a common brain neuropathy
    in Alzheimer's patients.
    Many pathological variants of Alzheimer's disease eventually lead to synaptic incapacitation and destruction
    .
    In addition, many patients also have brain network disorders, such as frequent variations
    in the brain's default mode network (DMN) responsible for episodic memory.
    In early Alzheimer's disease, synaptic incapacitation and DMN disconnection mostly evolve into local brain atrophy and accumulation of amyloid oligomers, resulting in dementia symptoms
    .


    Image source: 123RF


    The SinaptiStim-AD system developed by Sinaptica combines neurostimulation devices, brainwave monitoring technology, and the company's proprietary artificial intelligence personalization engine to personalize the patient's brain with electromagnetic waves, a precise, non-invasive treatment that can improve synaptic plasticity and stabilize the connections between brain networks, thereby improving the symptoms
    of dementia in Alzheimer's patients.


    "We are excited about the FDA granting SinaptiStim – AD System breakthrough medical device designation," said Mr.
    Rich Macary, President of Sinaptica, "This certification helps us establish the regulatory pathway for the SinaptiStim – AD System to be approved by the FDA, which is an important milestone
    for the company.
    " We look forward to working with the FDA to develop an innovative, safe, effective, non-invasive and personalized electromagnetic wave therapy
    for Alzheimer's patients.
    " We expect it next year
    Started pivotal clinical trials and continued to move forward
    in the field of electromagnetic wave therapy.


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