FDA Modernizes Approach to Alzheimer’s Research

Alzheimer’s disease is a complicated disease that is difficult to treat symptoms of once it has progressed to later stages of the disease. Scientists have been working to create medication to treat the cognitive impairment symptoms of Alzheimer’s and since the 1990’s have been required by the FDA as part of the medication evaluation process to submit data that demonstrates the medication provides an improvement on the cognitive functions of the patient. This data is required for all clinical trials using the medication.    This FDA evaluation condition, however, is harming research not helping it to advance.   A drug that targets stage 1 Alzheimer’s will not show cognition improvement for there is no impairment at this time.

There are three stages of Alzheimer’s disease.

    • The first has no symptoms but has present biological markers.
    • The second stage has the biological markers as well as symptoms of cognitive impairment but not signs of function impairment.
    • The third has the biological markers as well as impairment of both cognitive and functional impairment.


The new FDA approach ties medication trials to a specific stage of Alzheimer’s.   This will allow the FDA a better evaluation of a drug’s potential.   Drugs and treatments will be evaluated on stopping disease progression.    This is a major change in the way scientists look at treatment of the disease and is reflected by scientists taking an important look at what stage of Alzheimer’s the patient is in before recommending further treatment.

Key Points:

  • 1The FDA is changing its approach to Alzheimer’s patients so that it addresses earlier stages of the disease.
  • 2Stopping the progression of Alzheimer’s is just as important as improving cognition in later stages of the disease.
  • 3Biomarkers have been found to be of great importance in the diagnosis of this disease at all three levels.

In the earlier stages of Alzheimer’s and sometimes even into the mid-stages of the disease, there is often no issue with daily function.

See the original at: https://www.alzheimers.net/fda-modernizes-approach-to-alzheimers-research/

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