Medical Studies Update – October 2022

C-Diff Study

I was contacted to consider participation in this study while in the hospital in January 2018. This was looking at the efficacy of a new drug to prevent the occurrence of C-diff. You can read more about it at https://clinicaltrials.gov/ct2/show/study/NCT03090191. Over the next several months I had three doses of either the vaccine or a placebo. My participation ended in 2020, but no results had been posted at that time.

Earlier this year, Pfizer reported the results of the study (see here). While the study did not meet its primary endpoint of eliminating C-diff (there were 17 cases of C-diff among those receiving the drug and 25 cases among those receiving the placebo), there were some promising results. These included:

·         None of those who received the drug required hospitalization compared to 11 of those who received the placebo.

·         The median episode length of those who received the drug was 1 day vs 4 days for those who received the placebo.

·         The mean episode length of those who received the drug was 3 days vs 16 days for those who received the placebo.

Pfizer is currently evaluating what are the next steps to take.

Just a few weeks ago I received a phone call informing me that I had only received the placebo and not the drug being studied. This reveal was so that I did not need to be concerned about having to reveal my participation in this drug study for any future medical studies or hospitalizations. I’m happy to have participated and hope that the information received from this study will assist in the reduction of the impact of C-diff in the future.

[Injection]

 

 

Alzheimer’s non-drug studies

As I noted last year (see here), I am enrolled in three separate studies – known as ABC (Aging Brain Cohort), APT (Alzheimer’s Prevention Trials), and MTL (Medial-Temporal Lobe). The first two have no end date, the last is a 4-year study. I had my annual ABC and MTL visit last week.

Nothing of interest to report. However, I did find out that if I am accepted into the AHEAD study (see below), that my eligibility for the ABC study will end. I suspect that will be true for the APT and MTL studies as well. For now, I’ll continue on and see where things go with the AHEAD study.

 

Alzheimer’s drug study

Two weeks ago I had the memory testing for the AHEAD study that I had mentioned earlier (see here). Talk about comprehensive testing! It was essentially composed of the full ABC test (except tablet-based instead of paper-based), AND the full MTL test, AND the complete “Cogstate” test from the APT study. You name the type of Alzheimer’s test, I had it all on the same day. In addition, the day included a full suite of physical and neurological tests (blood pressure, ECG, visual and hearing acuity, “touch your nose, touch my finger”, walk to the end of the hall and back (looking for any gait issues or difference in left/right ability). Again, all the different ways that they try to detect if you have any symptoms of Alzheimer’s. Since they are looking for individuals who have no symptoms but who have a genetic predisposition and who have some level of amyloid plaque (my PET scan is next), this all makes sense. But it is pretty intense.

The AHEAD study is only looking for 1400 people at a number of test sites worldwide (compared to the C-diff study which has over 17,000 people). I asked how many were enrolled so far at UPenn. The answer was TWO – one in each arm of the study. There are a half-dozen at various phases of screening (which is where I am as well). But it’s evidently not that easy to find people who have no cognitive issues but who are disposed to Alzheimer’s (from their genetics and the presence of amyloid plaques).

Something else I learned for the first time. If I’m accepted into this study, then I will have to stop my practice of donating blood every eight weeks – because of the regular infusions that I’ll be having for four years. That’s a little bit of a bummer since I’ve been doing so regularly for several years now. The person who coordinates the blood drive at church will be disappointed, so I’ll wait until I’m actually accepted into the study before telling her (assuming that I keep passing the screening criteria).

So, are there weekly/bi-weekly infusions in my future? Time will tell…..

[infusion]