This is an interesting, long article in Politico, of all places, on Alzheimer’s (and diabetes) drug development. One focus of the article is on developing biomarkers. Biomarkers are “biological indicators in patients that can be easily measured, and that provide early indicators of whether an experimental drug is actually doing something that’s likely to help the patient. ” Of course we need biomarkers for all neurological diseases, not just Alzheimer’s.
Here are some excerpts from the article:
The effort largely revolves around finding better biomarkers for…diseases—that is, biological indicators in patients that can be easily measured, and that provide early indicators of whether an experimental drug is actually doing something that’s likely to help the patient. A good biomarker can drastically cut the need for massive, long-running, superexpensive trials, by giving researchers a fast, easily measured and reliable answer to the basic question, “Does this drug work?” It can also give basic researchers clues as to which research avenues are most likely to pay off, avoiding dead ends and speeding the early stages of development.
In Alzheimer’s, researchers have tried to judge the effectiveness of experimental drugs by assessing how the drug affects cognitive decline in patients—by giving patients memory tests, for example. The problem is that most experts now believe that by the time cognitive decline has advanced enough to be clearly detected through memory tests, any window for hitting the brain with a drug capable of staving off the disease has long since closed, possibly for two or more decades. Researchers can give people the drug earlier on in life, before symptoms show—but they might have to wait 20 or 30 years to find out if the drug worked, or even if a test subject had Alzheimer’s in the first place. What researchers need is a biological signal that can indicate a patient is developing Alzheimer’s years before cognitive decline shows up, and that can quickly measure whether a drug is slowing the progress of the disease. Though drugs that attack the brain plaques and tangled proteins that characterize Alzheimer’s haven’t worked so far in patients with cognitive decline, notes Lilly’s Skovronsky, plaques and tangles may in fact be the right biomarkers if they can be assessed in pre-cognitive-decline patients. That’s been hard to do in real time because the full extent of damage until recently could be clearly seen only in brain samples taken after the patient’s death.
Here’s a link to the full article:
The missing Alzheimer’s pill
When it comes to some of the biggest diseases America faces in the future, our drug system is set up to fail. What needs to happen?
By David H. Freedman
12/13/2017 05:19 AM EST