Today, I am at Advanced Memory Research Institute of NJ for my 18th EMBARK infusion. On this coming Monday, June 7th, the U.S. Food and Drug Administration makes what I believe will be it’s final decision on whether or not to approve the Biogen Aducanumab medication. I’ve prepared myself for either outcome, however I’m praying for a positive outcome. It’s been a long road to get to this point. There has been a lot of controversy surrounding Aducanumab for various reasons. I’m focused on my own positive personal experience, the medication will provide me with more time. I’m asking all of you to consider praying for guidance for the FDA committee members to approve Aducanumab.
#ENDALZ #aducanumab #EMBARK

EMBARK Infusion No. 16

Today I’m at Advanced Memory Research Institute of NJ for my EMBARK (Aducanumab) infusion. I haven’t posted since November as my wife Kimberly and I have been in the process of downsizing and moved into a 55+ active adult community. It was a lot of work but we’re comfortably settled in and I’m beginning to re-engage with my advocacy work. Yesterday I met with many Alzheimer’s Association executive and chapter board members to discuss the U.S. Food and Drug Administration’s review of EMBARK that will be held in June. Our position is that Aducanumab should be approved by the FDA.  This medication is about #MoreTime. Please go to this link and say YES to more time. https://www.alz.org/moretime #ENDALZ #Aducanumab

EMBARK Infusion No. 10

As many of you may know, on November 6th, the FDA advisory committee voted unanimously against the approval of the Alzheimer’s medication Aducanumab. You can hear and read the details here and here. Today I am at Advanced Memory Research Institute of NJ (AMRI) for my 10th EMBARK infusion and I continue to believe based on my testimony to the FDA that Aducanumab is working to extend my quality of life. I was concerned after the FDA hearing the trial would once again be ended but as of now the EMBARK Aducanumab trial will continue and there will hopefully be another placebo-controlled double-blind study forthcoming. In the meanwhile, I’ll be at AMRI monthly for my infusions, coffee, and good conversation with two of my favorite people, Anna and Lauren.

This month I was a little nervous as I prepared my statement to the FDA regarding my clinical trial participation. I felt as if the last four years of my inclusion in the trial were riding on the three-minute statement I was asked to deliver to the FDA and the scientific advisors. Of course, there were many other important things that keep me busy including my Walk to End Alzheimer’s fundraising that we’re still collecting for through December 31st.

Erin’s Wedding

This month was extremely busy, with an amazing wedding day for my daughter, I was able to check a very important item off my bucket list.  Also, this month it was my great honor to have served on the U.S. Department of Defense (DoD) Congressionally Directed Medical Research Programs – CDMRP Peer Reviewed Alzheimer’s Disease Research Program (PRARP) The press release can be seen here.

I’ve spent a lot of time working with Biogen as they prepare Aducanumab for FDA approval.  And, I’ve been working with the NIH/NIA Advisory Group on Risk Evidence Education for Dementia (AGREED) Patient/Community Stakeholder Subcommittee to prepare for some upcoming 2010 projects and doing a few podcasts.

EMBARK Infusion No. 7

Sportin’ my #Walk2EndAlz baseball cap, today I went for my seventh infusion and increased to 10 mg per kilograms per body weight.  This is the maximum level and I’ll be on this dosage for the remainder of my trial. It’s been a journey to get to this point and I’m very excited. I’m doing well and continue to encourage others to participate in Alzheimer’s research trials. Even though my trial, the Biogen Aducanumab EMBARK study is closed to enrollment, there are several other studies active and enrolling at my trial center, Advanced Memory Research Institute of New Jersey (AMRI). They have oralOral administration is a route of administration where a substance is taken through the mouth., subcutaneous injectionThe act of putting a liquid, especially a drug, into a person's body using a needle and a syringe., and infusionA controlled method of intravenous administration of drugs, fluids, or nutrients given without interruption, instead of by bolus. clinical trials like CASSAVA PTI-125-02, Graduate-WN29922, BAN2401-G000-301, GN40040, and there are more trials in the pipe line at AMRI.

Tony, my friend, and driver.

This past month we were busy preparing for all the content that would be available from AAIC20.  I got the chance to virtually join some of the most interesting sessions about new developments in scientific research, and clinical trials.  The technology sessions were particularly interesting.  I got a glimpse at some cutting edge tech for cognitive diagnostic testing.  In this photo, I have the pleasure of introducing my friend Tony.  Tony has been my friend and driver to and from my infusion since the very beginning.  We’ve become close friends.

EMBARK Infusion No. 6

On this day I decided to wear my authentic Amish straw hat.  Kim and I visit the Landcaster PA Amish county side each year for a little R&R.  It’s beautiful in the fall.  My visits to the center are always fun and there is plenty of time to joke and laugh with the staff.

The month I also had the opportunity to meet with some of my friends from Biogen to be interviewed and featured for there forthcoming Biogen Aducanumab insider newsletter.  The newsletter will be distributed to trial centers around the county and wherever the EMBARK Aducanumab clinical trial is held.

EMBARK Infusion No. 5

Today was a milestone for me and AMRI, we increased my Aducanumab medication from 3mg to 6mg per kg body weight.  All went well.  Prior to the increase in the medication, I went for an MRI to make sure there was no sign of what’s called brain  Amyloid Related Imaging Abnormalities (ARIA).  So far in all cases, this has not been an issue for me while on the original EMERGE protocol or the new EMBARK protocol.

Great news came out after this infusion. Biogen submitted Aducanumab for FDA Approval.

EMBARK Infusion No. 4

Infusion #4 at AMRI was a fun morning Lauren (l) and Julia (r) helped me make a quick video for the Alzheimer’s Association Greater NJ Chapter “We’re All In This Together” campaign.  This campaign is meant to show how the community of people living with Alzheimer’s Disease and Related Dementia and our care partners/givers support all the first responders and essential health care workers helping to fight the COVID-19 pandemic.

EMBARK Infusion No. 3

I’m happy to report that even though we’re still social distancing I was able to attend ARMI for my 3rd EMBARK infusion.  Masks, temperature, and many other necessary precautions are taken to be safe.   My friend Karin Hellsvik, Head of Patient Advocacy and External Communications, for Alzheimer’s Disease at Biogen helped with COVID-19 research. Biogen Employee and Recovered COVID-19 Patient Contributes to Antibody Research

Assembling PPE Face Shields

This month has kept me busy with 3D Printing PPE. We delivered over 250 PPE face shields to our local Ocean County, NJ COVID-19 testing center, senior living, and convalescent homes.   I recently began studying 3D modeling software and my Ender 3 Pro 3D Printer as part of STEM learning program.  The process of learning 3D Printing is very exciting and allows me to tap into and exercise my condition and executive functions.

3D Printing PPE Face Shields

3D Printed PPE Face Shields

EMBARK Infusion No. 2

During the last month I was a bit concerned about the possibility of a delay in my monthly infusions due to the COVID-19 crisis.  However, I got a call late last week telling me that my infusions were going to remain on track. I had a breath of relief as I had my first infusion for the new trial a month ago after a year-long hiatus that caught media attention worldwide.

Today I arrived at the Advanced Memory Research Institute of NJ via my friend and driver Tony for my monthly infusion. There was a new protocol in place at the front door to test my temperature and set me up with a mask, gloves and hand sanitizer. Basically, for my protection and everyone else, I had to have a normal ~98-degree temp to proceed through the glass lobby into the internal waiting area.

3D Printed PPE Shields

The atmosphere of the trial center was noticeably different this month due to safety protocols. Naturally, everyone was wearing personal protective equipment (PPE), some of it supplied by my friend and neighbor who is creating PPE shields with his 3-D printer.  I came ready with my own mask and gloves to not have to rely on their supplies.

I couldn’t see everyone’s smiling faces, although the positive demeanor and voices of the staff were shining through the obvious situation. There was still the hustle of the staff to care for a number of clients that were there for various protocols.  Dr. Sanjiv Sharma remarked several times how proud he was of his staff and how he “could not do this without them.”

Trial Coordinators Julia, Lauren, and Principle Investigator Dr. Sharma

I could not do this without them.Dr. Sanjiv Sharma

Elizabeth Preparing Infusions

I was encouraged to hear also today the center is actively screening previous enrollees of the Aducanumab clinical trial to bring them back online for redosing for the new EMBARK protocol.

Elizabeth prepares intravenous infusions for clients. These infusions are for the the Biogen Aducanumab and BAN2401 protocols.  AMRI has several active openly enrolling clinical trials.

Anna, me, and Lauren

Friday, March 13th, 2020 was an important day for those of us with Alzheimer’s who were previously enrolled in Biogen’s Aducumumab EMERGE and ENGAGE Alzheimer’s clinical trials. My trial center Advanced Memory Research Institute of New Jersey (ARMI) was selected as the first center to come online for the new re-dosing protocol, EMBARK, and I had the distinct honor to have been selected to be the first re-enrollee worldwide.

There is a lot of science, analytics, news media, and history behind the Aducanumab clinical trial since the cancellation in March of 2019, however, Biogen in a surprising and welcome announcement in October of 2019 said they were going to pursue regulatory FDA approval for aducanumab and begin redosing eligible patients previously enrolled in the Phase 3 studies like myself.

I’ve always been a joyful and hopeful person and even though there was a time of grief last year I never gave up hope in the scientists and researchers at Biogen. When the news came out on October 22nd, 2019, I literally jumped out of my seat and ran upstairs where my wife Kim was showering and my shouts of joy were misinterpreted as though something bad was happening. We had to take a breath to collect ourselves and check the news again. Indeed, it was time to celebrate. I was in touch with my trial center that morning and Biogen had reached out to me as well.

Several months went by as we participants and trial centers waited for our partners at Biogen to ready the redosing schedule and parameters of the new trial. It’s important to point out the use of the word partners. We are all partners in this clinical research, from the technicians crunching data in labs at Biogen to clinical coordinators at the trial centers to us the participants. I feel a sense of honor to be part of this extended team of humanitarians.

Getting ready for my first MRI for EMBARK

There was a lot of diagnostic testing over the last two weeks leading up to this past Friday. AMRI, beta-Amyloid PET scan, a lumbar puncture (LP) to obtain cerebrospinal fluid (CSF) and several memory and cognitive exams. This may seem laborious but all of these tests are necessary to add to the efficacy of Aducanumab. The LP, however, is voluntary and I chose to do the test to help obtain more data for the trial.

For the next two and a half years, I will go each month to AMRI for my hour-long infusions, each one more important than the last as the medication level will be increased over a few months to the max level of the medicine.

Aducanumab is not the only clinical trial for Alzheimer’s disease. My trial center has three active and enrolling studies and you can use Alzheimer’s Association’s TrialMatch or the CenterWatch.com website to find a center and study near you.

Clinical trial enrollment is fundamental to finding a cure for Alzheimer’s disease and we need early-stage participants that span generation, gender, and race.