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In this episode, we talk about…

[2:25] The Banner Health Alzheimer’s Institute (BAI)

The BAI was founded in 2006 by Dr. Eric Reiman, who had developed a strong interest in the imaging side of Alzheimer’s Disease during his fellowship.  When he came to Good Samaritan Medical Center (now Banner University Medical Center) in the early 90s, he was the first person to bring a PET scanner to the state of Arizona.  Unlike an MRI or a CT, PET actually images the metabolic activity of the brain.

In order to do a PET scan, you have to have a PET radiotracer – a compound with a very short half-life (around 120 minutes).  They developed the first radio chemistry facility within the state of Arizona as well, where they could actually manufacture that compound on site.

In 2006, Dr. Reiman’s research expanded to include clinical trials.  At that point, Dr. Pierre Tariot joined the newly formed BAI.  Since that time, it has grown exponentially. 

[7:31] An overview of BAI’s research studies and success stories

The research projects enroll not just those with memory or neurodegenerative disease issues, but also healthy volunteers in both the memory disorders clinic and the treatment research studies, which include the pharmaceutical clinical study.

Non-treatment trials are typically called observational studies.  It’s really important to understand what healthy aging looks like.  When someone who has cognitive issues or is progressing through Alzheimer’s, they can compare that to what an individual looks like who does not have any disease or cognitive issues.  

Around 25 years ago, Dr. Reiman started a cohort study in which he brings in healthy participants every other year.  They do cognitive assessments to gauge their thinking and memory, and they also do brain imaging.  So they do PET scans and MRIs, and they collect biospecimens (blood and spinal fluid) through a lumbar picture.  This study has had some pretty amazing results, and it really sets the foundation for what healthy aging looks like.  As you then study someone over 25 years, you will identify changes that occur.  Dr. Reiman has been able to identify different biomarkers, or different proteins or structures in the brain, that are signs of the neurodegeneration that might be related to cognitive impairment.

Analysts are able to pinpoint changes that occur with normal aging versus those that occur with cognitive decline.  These changes tell them where to focus future research efforts.  For example, some of the things they see are amyloid plaques developing in the brain, as well as abnormal tau accumulation in the brain.  There is a thought that these things contribute greatly to cognitive decline, but the complex mechanisms about how that actually happens is still being studied.  With clinical trials, you can focus on trying not just to treat symptoms or side effects of dementia once it occurs, but you can also look to develop treatments that will prevent the plaque or tau from forming.

Dr. Reiman has really set the standard for identifying the changes that occur before clinical symptoms appear.  Last year, he had a large publication that might lead to a blood test for Alzheimer’s Disease.  This would be huge progress, as typically it is diagnosed after death through an autopsy, or through the complex imaging described earlier.  A blood test would be so much more accessible. 

One of the major projects they entered into with a large pharmaceutical company was a project in Medellin, Colombia.  There was a group of people in that region that were genetically linked, and a neurologist there started seeing this connection between family members who would all have symptoms starting around age 45.  It was early onset for the disease, and they suspected a unique genetic link.  It was an ideal population to start looking at some of the pre-symptomatic treatments.  They were predisposed to have high risk for early cognitive decline, and they agreed to receive immunotherapy to see if that could stave off the disease or slow the progression.  This study has been going on for over seven years, and over 300 people participated.

There are a lot of other pharmaceutical trials that BAI is participating in as well, and many are looking at prevention.  Some are treating the symptoms of dementia, so looking at ways to reduce agitation or slow down the memory decline.  At any given time, they have between a dozen and two dozen different clinical trials going on in addition to their biomarker work.

[15:23] Jennifer’s role as a director of research

Jennifer has a team of clinical research coordinators that really actively work with participants.  Her role is to make sure that the studies are in line with what Dr. Reiman, the lead investigator, wants.  He will provide the objectives and the goals, and Jennifer brings it to fruition.

This involves working with the finance team to figure out the budget, and working with other regulatory bodies.  They have to write out a protocol, which lays out the details of the study from start to finish (this often encompasses several years).  What does it look like for the participants? How will you communicate with them? How will you recruit them?  It is Jennifer’s responsibility to ensure all those pieces come together.  She coordinates communication with participants, data collection, and data analysis.

[17:58] Connie’s role as director of operations

Connie oversees the departments of MRI imaging.  They have a 3T MRI, so they can see a lot of detail in the brain.  They can also do what is called task-based functional MRIs, and many researchers from ASU like to use this because they have a computer screen they can see.  There is a set of goggles they have that mimic a computer screen, and they will get instructions to respond to questions.  They can tell a lot about what’s going on with changes in the brain because they can actually watch the brain rather than just seeing static images.

Another option is to do safety MRIs for clinical research and treatment trials.  They also have the PET center, and two CT scanners that are heavily used to support Jennifer’s trials or biomarker research.  They are also used to support clinical trials for investigational drugs or pharmaceuticals.  They want to make sure they are really watching what is going on in the brain from a safety perspective, as well as from an efficacy perspective – is the pharmaceutical doing what they expect it to do?  They can scan for amyloid plaques, tau tissue, inflammation, and glucose uptake.

A PET is unlike an MRI where they can see a physical or anatomical structure.  With amyloid scans, they haev compounds that the amyloid tissue in the brain has a strong affinity for.  When you inject that into somebody’s blood stream and give it time to metabolize, the amyloid tissue will grab it.  Since they have tagged it with a radioactive marker before injection, the marker is then emitted for the PET scanner to pick up.  Those areas where the tracer accumulates represent the amyloid burden in the brain.

Connie shares that she manages a group of really, really smart people.  While she can’t do what they do, it is her responsibility to make sure they have the tools and resources to do their jobs.