Outcome of a Pilot Clinical Trial of the Supplement Formula #12
to Address Quality of Life Issue for Parkinson’s Patients
Steven Evans
Trial Administrator and Senior Research Scientist
Therapeutics Research Institute
Omaha, Nebraska
Design
We reserved enough clinical positions for up to 30 individuals. Our minimum goal was to have 20 active participants. During the enrollment time frame in which we worked, once we received 20 acceptances, we closed enrollment at that point since we anticipated this would yield sufficient informative data regarding the supplement.
Data Outcomes
The summary of the experience of each participant on Formula #12 is given below:
Participant #1: On trial 17 weeks, with improvement seen in all of his listed 13 symptoms. Counted as a responder.
Participant #2: After 4 weeks, there were limited responses in 2 of 8 symptoms and so was counted as a non-responder.
Participant #3: There were no responses after 4 weeks and so was counted as a non-responder.
Participant #4: After 7 weeks, only one symptom showed improvement of 9 and is counted as a non-responder.
Participant #5: Showed improvement in all 6 of his symptoms over his entire 11 week period. Counted as a responder.
Participant #6: Showed improvement in 7 of 15 symptoms in the first week, and 12 of 15 symptoms by the 4 week. Counted as a responder.
Participant #7: All nine of 9 symptoms responding by the second week. A strong responder.
Participant #8: Five of 11 symptoms helped by the first week, six by the sixth week, and 7 by the eighth week. A responder.
Participant #9: Of 12 symptoms, 6 were helped by the first week, 8 improved by the second week, and all 12 improved by the third week. A responder.
Participant #10: Of a total of 11 symptoms, 3 were helped by the third week, and 4 were improved by the fourth week. A responder.
Participant #11: Of 11 symptoms, none were improved by the third week. A non-responder.
Participant #12: Of 6 symptoms, none improved by the third week. A non-responder.
Participant #13: Of 4 symptoms, one improved the first week, but even after 16 more weeks, the overall picture did not improve. A non-responder.
Participant #14: Of 12 symptoms, 2 were helped by the third week, but by the fourth week, there appeared to be no net improvements. A non-responder.
The following 6 participants either withdrew immediately or never even began the trial
Participant #15: This participant had no improvement in the first week and apparently decided to quit. This unfortunately does not allow us to ascertain if he would have benefited since in other case studies we found that it usually took three weeks for some responders to materialize.
Participant #16: This participant decided not to begin after all.
Participant #17: This participant did not like the non-capsule form and terminated immediately.
Participant #18: This participant did not send in any forms and did not respond to repeated inquiries and emails.
Participant #19: This participant felt Formula #12 was unsettling to the stomach and quit promptly.
Participant #20: This participant decided not to begin after all.
Data Summary
Overall, there were in total seven positive responders, seven negative responders, and six who elected not to participate after all, after receiving their supplements or did not participate after a several days. The overall outcome was a 50% response rate among those who actually completed the minimum of three weeks of the trial. Some participants were on trial as long as 17 weeks. Six of the seven responders showed improvement over a substantial majority of all their symptoms. The non-responders were the opposite with either no improvements or improvements over just one or two symptoms. Clearly individuals either definitely benefited — or definitely did not.
Discussion
It is quite remarkable to achieve a 50% impact rate. What this tells us is that if alpha lipoic acid can be delivered inside the cells as the Formula #12 uniquely did, then patient symptomatology is markedly reduced in something on the order of half the Parkinson’s patients. This might also imply that half the Parkinson’s diagnoses are in fact deeply different from the others. This other half are displaying the same set of symptoms but the underlying etiology might be markedly different. This would be an interesting area for further research.
From our experience both with this trial and with limited prior case studies, I would speculate that one possible difference among Parkinson’s patients is the nature of the toxic build-up that has accrued in their cells. Where the build-up is primarily related to hydrogen peroxide build-up, Formula #12 may be very instrumental. Where the build-up may be primarily a function of heavy metals such as mercury and lead, although there still is likely to be some of the hydrogen peroxide build-up, what is needed is a chelation agent — that is, an agent that will substantially leech out the dangerous heavy metals in order to clear the cells so that they may potentially create the dopamine needed.
Trial Directions
A preliminary version of the data was presented to key national-level Parkinson-interested associations in the hopes that they may fund from several hundreds to even several thousand additional patients. Unfortunately both indicated a lack of interest unless we already accrued and undertook a trial of perhaps several hundred patients, and ideally, several thousand. Since this was what we were seeking funding to do, as a result, there is no further progress on this trial since the researchers were committed to providing product without charge to participants at all stages of all the trial efforts. After this mini-trial, such a strategy of a larger trial depended on finding additional outside funding. Recall that neither the trial sponsor (TRI) nor the manufacturer was pursuing any “product for sale” model, so without further expanded funded trial prospects, there is no follow-up to this effort, other than the limited insights that might be gleaned from the effort.
