The Trial of My Life

For whatever reason, Lewy body dementia (LBD) clinical trials on new medications are rare. Those of us in the early stages need to embrace the opportunity to participate in trials so our families, our supporters and advocates, our medical community, and – perhaps most importantly – our fellow Lewy Body patients can get a more accurate understanding of the journey we face. We must ask ourselves “If not us, then whom?”
When a local clinic announced they were doing a new drug related study for Lewy body dementia, I immediately applied. The currently prescribed medications were first developed for other forms of dementia. While these medications slow the symptom progression, they do not offer a long term solution to the ravages of the disease.
My first research study visit was the screening to see if I qualified for the study. There were the usual battery of neuro-psychiatric testing, a thorough physical examination and a ream of paperwork. Thirty-six years in with the Army prepared me well for the task ahead of me. With a battle cry of “Onward bound”, I decided, “Let’s make this happen.”
Immediately I was informed that I passed the screening and a new excitement became my constant companion. With this journey, I am helping others with the possibility of a finding a drug specifically for LBD. Being early enough in the progression of symptoms was also a benefit. With more study participants in this stage, the better researchers could assess the progression of the symptoms.
The first appointment in the study consisted of a 30-page consent form. We all know that the federal government requires written consent for everything; each part separated. Then came a repeat of the cognitive assessment; a baseline measurement was established. Another physical examination included blood work, urinalysis, and an EKG. Saying that this was a complete and thorough first day would be an understatement.  
The researchers also provided the medicine in this double blind, placebo-controlled study. This meant the assignment of either a placebo or the new drug, Neither the doctor or I would know which of the two I received until the trial is over.
The next few visits would be a repeat of the above. This allowed me to see how the disease was progressing and what in my capacities was stable. In my case, word recognition and memory measured lower each visit. The pills left in each respective bottles were counted each time to make sure compliance was maintained.
My daughter, who is my caregiver, was interviewed at each session. The study personnel would not disclose what was discussed in these interviews. Rest assure that it was the issues she observed and the progression that occurred between each interview. In a strange twist of irony, my child and I were now in a role reversal; I always thought of caregiving was a parental responsibility. She continues to be a “rock” in supporting me. This is extremely comforting since my wife and my “shoulder to lean on” passed away four months ago.
As of this writing there are three months left in the initial study followed by an eight month “open-label” study when all participants will take the experimental drug.  A full written report of this study will be constructed and released shortly after the next phase. Until that time, all participants will wait with full anticipation for the results.
So ask yourself: “If not me, then whom?”. There are unique parallels between John F. Kennedy’s Inaugural Address and this study. On that historic moment in time, he asked the following: “… and so my fellow Americans, ask not what your country can do for you. Ask what you can do for your country.” As people living with LBD, if we are to find a cure, we should be asking ourselves a variation on this very important question.

Alan Silberstein

Feb 21, 2017