How do we prove to the FDA that MSF Works?
This was a pretty crucial question to answer. Without having a good idea of how to show quantitative memory improvement, an Alzheimer’s treatment would be dead in the water, and while Dr. Moss had designed numerous experiments as well as run a clinical trial for efficacy, all of these were with small samples. The testing for memory improvement needed to be streamlined so that we could easily collect data on as many as two hundred subjects through quick and easy tasks that wouldn’t put too much strain on either the Alzheimer’s patient or their caretaker. One of the big concerns when running large scale trials is that if your tests are too onerous, you’ll have a large dropout rate and may end up with an insufficiently representative sample to satisfy a regulatory body like the FDA.
With this in mind we contacted Dr.Edward Awh and Dr. Edward Vogel at the University of Oregon. Both Eds have existing labs that study visual working memory and attention, two major faculties damaged by the progression of Alzheimer’s disease. They accepted the task of putting together FDA compliant tasks that could demonstrate a change in a person’s basic physiological ability to remember things, even after repeated exposure to the same procedure (ie, they can account for the learning effect).
Excerpted from an email to me by Dr. Vogel:
The plan for assessing the efficacy of MSF by testing memory functioning in Alzheimer’s patients.
Our general plan for doing this involves two basic components:
1. Clinician-administered tests (once every 3-4 weeks during the study) which will include the ADAS-Cog (a battery of cognitive tests for alzheimer’s that has been the standard measure in nearly all clinical trials of cholinesterase inhibitors); and one or two questionnaires regarding Daily living activities and function to be filled out by the patient and caregiver. These tests should take approximately 45mins to 1 hr to complete.
2. Remotely-administered tests via computer (once per week during the study) of memory and cognition which will include assessment of picture memory, paired-association with words, delayed free recall of words, and the COWAT (Controlled Oral Word Association Test) which measures the individual’s ability to fluently generate words of a particular type (e.g., say all the words you can think of that start with the letter “F”). Together, these tests will take approximately 20mins to complete.
He ended the email suggesting that they should be finished with the test development process by the end of March, putting us well on schedule to proceed as soon as the long term, FDA compliant toxicity studies are completed.
I’ll admit I’m kind of curious to take one of these memory tests myself. I’ll probably keep the results confidential though.