2020 Clinical trial … phase two testing of MCC950

PERHAPS I can have an opportunity to participate in this one, too???

“The progress of MCC950 to market appears to be happening rather quickly. Both the Michael J Fox Foundation for Parkinson’s Research and the Ireland-based drug company Inflazome are keen for human trials to start as soon as possible.

Dr Woodruff said much of the preclinical work was already completed.

The biggest hurdle, apart from funding, is that MCC950 came off a patent. This means the researchers have had to develop variations of the original drug for intellectual property reasons. Those new drugs are currently being tested and, according to Dr Woodruff, proving to be even more effective.

There are 10 million people with Parkinson’s disease worldwide. They still have a few years to wait and see if the magic in the lab can be replicated in people.

The phase-one tests next year will determine whether or not the drug is safe in healthy people. All going well, volunteers with Parkinson’s will be recruited for phase-two testing in 2020.

Whether Michael J Fox himself will be one of those volunteers is not yet known.”

 

Alpha-Synuclein updates

I am posting this just prior to the four strategies for gut health… You should see why. 🙂

You may recall from an earlier post: STUDY PURPOSE: The most urgent unmet medical need in Parkinson’s disease is a treatment targeting the underlying disease mechanism and thus prevent the disease from progressing rather than only controlling symptoms. The study drug tested in this study is a new chemical compound called UCB0599, which could have such effects by preventing the aggregation of alpha-synuclein in the brain, which is thought to be the main driver of the disease progression.

Since the alpha-synuclein is the focus of our current clinical trial… I found the following to be of great interest.

Notes from the convention as passed on by Laura Kennedy Gould’s Blog : THE MAGIC TRICK-Life With Parkinson’s

Alpha-Synuclein in your gut

I attended a technical lecture about alpha synuclein (A-syn).  Since the last congress three years ago, A-syn has been found in the appendix.  Apparently, a-syn spreads from the appendix to the gut and by the vagus nerve to the brain.   Different shapes of a-syn aggregation have been identified with each representing a different disease – i.e. PD (spaghetti), ALS (ribbon fibril) or MSA (linguine).  These aggregates form Lewy bodies.  The scientists have discovered that a-syn connects with 178 proteins; however it is not yet known if any of these cause PD or are a result of it.  What I gather from this is that the researchers have learnt a lot but are no closer to finding a cure.  Additional testing and research is needed to further define the role of a-syn and Lewy bodies in relation to PD.

Strange Happenings

I want to tell you about our sleeping quarters at the clinic where the Parkinson’s clinical trial is being conducted. There are 9 beds in the ward that John & I were assigned to. We could have our choice of beds. Wouldn’t you know… I picked a bed with a mind of its own?

We have individual curtains which could be pulled around for privacy, but no need. There are currently only 6 people here and with three wards, we have ours to ourselves. We are free to stay in our room, or sit in the dining room, or one of the two other rooms designated for TV watching, game playing, etc,

There is no specific time for waking up or retiring for the night. On the free days when there are only vital signs and pills to be taken, each participant has a few guidelines. For me, I am not to eat anything for three hours before they give me my dose (capsule) and I am not to eat anything for at least half-an-hour after dosing. I get my meds at 8:25 a.m [so breakfast is served at 8:55] Then the evening meal is served at 5:00 pm {I need to be through eating by 5:25} And my evening dose is 8:25.

I have read 3 novels & John is working on his third jigsaw puzzle. This is day 12 of the 30 day study.

On our first night here, I was pretty soundly asleep, when I heard the motor on the bed and it elevated my head slightly, and stopped. Due to my sleepiness, I didn’t rouse much. After the bed’s bizarre behavior had happened twice more, I had awakened sufficiently to recognize the need to trot to the little girl ‘s room. “What the?” When I returned and started to get into bed, the top half of the bed was all the way up! Perpendicular! As if sitting up straight!

The bed’s shenanigans had aroused John enough, that he thought I was having a hard time sleeping, not realizing I wasn’t in the bed, till I returned from the bathroom. We unplugged the bed, after coaxing it to lay back down.

When we reported the malfunction to the medic, Doug, in the morning, he related what had transpired, the last time the dorm had been used. The clinic had had a larger study going on and the room had been full of ladies. They had come running out of the room declaring one of the beds was possessed. He thought they were just messing with him, talking about poltergeist. The bed never acted out when he was in the room.

Doug had a good laugh, when John told him, ‘When he’d plugged the bed in, he’d noticed that the grounding prong was missing. So we’d figured that must account for the strange happenings.’

 

Progress Report

I am pleased to report, things look like I am accepted for the study. I have the option to drop out at any point in time. They have received records from my primary care and were happy to see the MRI was current enough, another did not need to be scheduled. After reviewing what supplements I have been taking, I was asked to discontinue all herbals for the duration.

We return for a follow up interview and a thorough physical this coming Monday… which is anticipated to take around 3 1/2 hours. At that time, I anticipate being able to tour the 27 bed facility and ask all my questions, prior to officially signing on for the clinical trial.

All study participants are provided scrubs, so packing for me will be light. John will be provided sleeping accommodations and meals, but will also be free to leave to attend the temple, church, or whatever he chooses.

Any questions you think I should be sure to ask?

I may participate

I had a phone interview this morning. I passed the pre-qualifications and have an appointment tomorrow morning, at the clinic site in DeLand, to learn if I am accepted to participate in a study.

The study intrigues me, because …as I posted before, I have been taking an enzyme I found referenced to as beneficial in breaking down the build up of alpha-synuclein.

………………………….Serropeptase & Parkinson’s
12/29/18 Dr. Berg recommended … Serropeptase  3 x’s a day on empty stomach  suggesting enzyme may break down or dissolve build-up of protein (alpha synuclein) in the brain.

I found this additional insight on ‘MyParkinsonTeam.com’: “Now known as Lewy bodies, these deposits of alpha-synuclein (aS) protein are understood to be one of the most common causes of dementia in people with parkinsonism.”

…………….I expect they will require that I discontinue taking the enzyme, for the duration of the trial… but that is ok.

STUDY PURPOSE: The most urgent unmet medical need in Parkinson’s disease is a treatment targeting the underlying disease mechanism and thus prevent the disease from progressing rather than only controlling symptoms. The study drug tested in this study is a new chemical compound called UCB0599, which could have such effects by preventing the aggregation of alpha-synuclein in the brain, which is thought to be the main driver of the disease progression. This is strongly supported by studies in animals but it is still unknown if UCB0599 will provide real benefit to humans. The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of multiple doses of UCB0599. Pharmacokinetics means measuring the amount of the study drug in the blood and how long it stays in the body. For this purpose, Study Participants will be randomly (by chance) assigned to receive either the study drug or a placebo, both provides as capsules. A placebo is a “dummy” capsule without UCB0599. Participation in this research will require participants to stay in a clinic or trial unit for 30 days (28 days of treatment and 2 days for safety follow-up). The study drug differs from purely symptomatic drugs currently available and may improve the medical care of patients who do not respond to, or cannot tolerate current drug treatments for Parkinson’s disease. The drug also has the potential to have a positive effect on a much broader range of symptoms of PD, including non-motor ones (like cognitive issues). The study is expected to provide critical safety and PK data required for a larger study to test if the drug works in PD patients.”

I will send updates to confirm if I am accepted.