About the MINDSET Program
MINDSET is a Phase III clinical research program evaluating an investigational medication, RVT-101, for mild-to-moderate Alzheimer’s disease. Researchers are investigating how effective RVT-101 in combination with donepezil (sometimes known as Aricept®) will be in helping with patients’ cognition and ability to perform daily living activities, as compared with donepezil alone.
About 1,150 people worldwide are expected to participate in MINDSET.
What does study participation involve?
Study participation involves:
•Attending a study-screening visit to determine eligibility for the study
•Coming to the study center for 9 study visits (including the study-screening visit) over a 33-week period to assess health and/or study drug effects
•Taking study-provided donepezil (the generic form of Aricept®) throughout the course of the study
•Taking the investigational drug or placebo for up to 24 weeks
•Caregiver participation to answer questions asked about how the person with Alzheimer’s is feeling and functioning
•At the completion of the study, the opportunity to participate in a 12-month extension study where all study participants will receive the investigational medication
At the study center, study staff will discuss participation in MINDSET in more detail.
Why participate in MINDSET?
Information collected from MINDSET may help with the development of new drugs to treat Alzheimer’s disease.
Study participants will receive, at no cost to them:
•Study-related monitoring from study physicians and medical teams experienced in Alzheimer’s disease
•All study‐related exams and tests
•The opportunity to receive the investigational drug
•Donepezil (the generic form of Aricept®), provided to all study participants at no cost
Transportation assistance or travel reimbursement will be provided to study participants. Compensation for study-related time may also be provided.
•Study participants can continue to see their regular doctor(s) while participating in MINDSET
•Medical insurance is not required to participate
•100% of study participants who complete the double-blind study will be eligible to continue into a 12-month open-label extension study where all participants will receive RVT-101
Are you or a loved one interested in participating in MINDSET?
The Investigational Drug
How does RVT-101 work?
RVT-101 works by raising levels of acetylcholine, a vital chemical in the brain that helps with cognition and performing daily living activities. RVT-101 increases the release of acetylcholine directly, similar to turning up a faucet. Aricept® (donepezil), the most widely used medicine to treat Alzheimer’s today, also increases acetylcholine in the brain, but does so indirectly by preventing acetylcholine from being cleared from the brain, similar to blocking a drain. In combination, RVT-101 and donepezil work together to increase acetylcholine by both turning up the faucet and blocking the drain.
RVT-101 is an investigational medication (a drug that is not yet approved by a regulatory authority such as the FDA). It is a tablet that is taken once per day, with or without food.
Because RVT-101 is an investigational medication, it is available only through this clinical research program.
Has RVT-101 been tested in previous clinical studies?
RVT-101 has already been tested in 13 clinical studies, including a 684-subject study where the combination of RVT-101 and donepezil was observed to provide statistically significant benefits on study participants’ cognition and ability to perform daily living activities, as compared to donepezil alone. The MINDSET program aims to confirm these results.
What are study participants’ chances of receiving the investigational drug?
All study participants will have the opportunity to receive RVT-101 during their participation in the MINDSET program.
The MINDSET program will include a 6-month “double-blind” study followed by an optional 12-month “open-label” extension study.
Participants in the “double-blind” study will have a 50% chance of receiving the investigational medication, RVT-101.
During the double-blind study, study participants will be placed randomly (by chance) into one of two groups:
Investigational Drug Group:
Donepezil (the generic form of Aricept®) + RVT-101
Donepezil (the generic form of Aricept®) + Placebo
Open-label extension study:
Following completion of the 6-month double-blind study, all study participants will have the opportunity to participate in an “open-label” extension study. In the open-label extension study, all study participants will receive the investigational medication, RVT-101. Participation in this extension study will last for 12 months.
All study participants will receive study-provided donepezil (the generic form of Aricept®) throughout their involvement in the MINDSET program.
Well that is it in a nutshell
We got involved through a conference call we participated in a few months back. The conference call was put on by ALZ.org. It was informative and the study seemed promising. We have tried to get in various other studies but did not meet their criteria. They don’t actually tell you why but just a yes or no.
The screening process for this study was extensive and took three visits to complete all the testing required. Verbal and written tests to confirm her level of cognitive impairment and even had many questions for me to answer. Blood test, MRI and various neurological tests.
We actually had to adjust our travel schedule since the first 4 visits have to be exactly 3 weeks apart and when we come back in for tests after each 3 week period it is an all day affair at the Atlanta Research Clinic which is about 10 minutes from our usual hotel in Atlanta.
The staff there are very good and understanding. After the first 4 visits then will have 5 visits that are 4-6 weeks apart. After the 6 months she will continue on for 1 year and at that time she will get the drug RVT-101 and the belief is that after that period of time the drug will be approved and on the market.
There is a down side to this study and that is the fact that she was currently taking twice the amount of donepezil. She was also taking a shake made of Axona which is classified as a prescription medical food intended for the clinical dietary management of the metabolic processes associated with mild to moderate Alzheimer’s disease. Axona is not a drug and is different than currently available Alzheimer’s drug treatments. Adding Axona to Alzheimer’s disease management may address a specific nutritional deficiency not addressed by FDA-approved Alzheimer’s treatments.
This study is very specific and is intended for folks that are only taking donepezil at the 10mg level for at least 1 month before starting this clinical trail. She had also started taking Amenda XR but that was only for a few weeks. On the upside we both actually get paid per visit. 80 dollars per visit for her and 60 dollars per visit for me. We also feel that we will be taking an active role in finding a cure for this disease.
We just finish up another all day testing for the final approval to actually start the program. Both of us were asked hours worth of questions and Catherine had to take some written and oral tests. They checked our compliance with the placebo that we were given 3 weeks ago and made sure that her condition has not changed drastically since the last visit.
We were finally given approval to enter the program and were given a bottle that was simply listed RVT 101 or Placebo. The questions they asked me about Catherine gave me a good idea of where she is in terms cognition. They stated that previous studies showed significant benefits so we should see some improvements quickly or not.
I have noticed that she has not really gotten worst in the last 18 months since we have been nomads so if we have to wait another 6 months before she will for sure get the new drug it is well worth it. I doubt if her health will decline during that period of time. Also it is our belief that our current nomad life style is a benefit to her. I talk about that in great detail in the previous blog called. Please Share Someone, you may know, with Younger-Onset Alzheimer’s.
This is an update to the Mindset program.
We made it through the first phase and have been approved for the second phase which is getting the actual drug RVT-101. We had an entire day of testing and I can say that she has not gotten much better but also has not gotten any worst.
We did get some disappointing news about where we go from here after this next 8 sessions are done. Figure that will take from 8-10 months but after this phase she has to come off the drug. They figure it will still be several years before the drug hits the market so we will have to look for other types of drugs or therapies for her.
Travel is one that we will continue to do but have been thinking about getting a small apartment in ATL since we probably will slow down after next year or the year after. Here is something that came across on Facebook that sounds promising.
Does Exercising Your Brain Do any Good?
These days, a lot of people will tell you, “I do puzzles to keep my brain sharp.” But have you ever wondered if those endless crosswords and Sudokus actually make a difference in reducing “senior moments”… and possibly even dementia?
Scientists from Tel Aviv University have recently uncovered the answer … continue reading to find out!
Research from Tel Aviv University has proven that exercising your brain can truly make a difference in preventing Alzheimer’s disease. But the way it works might surprise you!
Alzheimer’s disease develops when certain types of proteins (called amyloid-betas) aggregate into plaques. These plaques build up between the nerve cells responsible for the brain’s electrical communication, causing the classic signs of dementia like slow speech and memory loss.
However, just as there are two types of cholesterol—one healthy and one dangerous—the same is true for amyloid proteins. Scientists now believe that a high level of amyloid-beta 40 is healthy, while amyloid-beta 42 is dangerous because it’s more likely to accumulate into plaques. If you have a high ratio of 40 to 42, you’re likely to be in good neurological shape.
So how does exercising your brain make a difference?
Here’s how it works, according to Nature Neuroscience
Dr. Inna Slutsky and her team showed that by using high frequency “bursts” of electricity in the animal hippocampus—the center of learning—they could increase the production of amyloid-beta 40.
This led the team to conclude that people who experience regular “bursts” of sensory experience can physically increase the level of amyloid-beta 40 in their brains. These kinds of bursts include environmental changes, new experiences, emotional reactions, and sessions of learning and focus (including completing crossword puzzles).1
Scientists are even optimistic that this discovery could, someday, lead to a gentle electric treatment for Alzheimer’s. But don’t worry—it would be pain-free! Says neurologist Amos Kocyzn, also from Tel Aviv University, “Unlike crude electroshock treatments used in schizophrenia, we are talking about a very delicate, gentle and highly focused electrical stimulation.”
How to create your own “bursts”
Prevention is always the best medicine. There are many easy, free ways to create the same types of electrical bursts in your own brain.
Each of these applications forces your brain to adapt, think differently, and re-wire your neural network in a process scientists call neuroplasticity.
- Read every day, and not just your normal fare. If you always read the newspaper or technical journals, try fiction, and vice versa.
- Do puzzles. Crossword puzzles, Sudoku, riddles, logic puzzles… anything that makes you stop and think for a period of time will do it.
- Learn a new language. A study performed at the Swedish Armed Forces Interpreter Academy showed learning a language causes significant brain development in the hippocampus (center of learning) and three areas of the cerebral cortex.“There is a lot to suggest that learning languages is a great way to keep the brain in shape,” said Johan Martensson, a psychology researcher at Lund University, Sweden.2
- Take an online course. Several universities offer free “open courses” with materials and lectures online. If you always meant to learn more about French culture or astrophysics, now is a great time to start!
When you perform “brain exercises” like these, you literally strengthen your brain, increase the strength and connectivity of your neural networks, and you get the benefits of increasing your levels of healthy amyloid-beta 40 proteins.
Whatever you decide to do, it’s my opinion that you should start soon. It’s never too late to start fighting Alzheimer’s disease.
We are doing our part with seeing and doing new things everyday and also she does a lot of reading on her iPhone, As we continue to travel going to make a better effort to learn some words of the natives and maybe a crossword puzzle or two.
In response I got a message from a friend that mentioned another study that sounds promising. I had heard about it before but now that we will be kicked to the curb in less than a year need to continue for new ways to stave off the disease.
Of the mice that received the treatment, 75 percent got their memory function back.
Australian researchers have come up with a non-invasive ultrasound technology that clears the brain of neurotoxic amyloid plaques – structures that are responsible for memory loss and a decline in cognitive function in Alzheimer’s patients.
If a person has Alzheimer’s disease, it’s usually the result of a build-up of two types of lesions – amyloid plaques, and neurofibrillary tangles. Amyloid plaques sit between the neurons and end up as dense clusters of beta-amyloid molecules, a sticky type of protein that clumps together and forms plaques.
Neurofibrillary tangles are found inside the neurons of the brain, and they’re caused by defective tau proteins that clump up into a thick, insoluble mass. This causes tiny filaments called microtubules to get all twisted, which disrupts the transportation of essential materials such as nutrients and organelles along them, just like when you twist up the vacuum cleaner tube.
As we don’t have any kind of vaccine or preventative measure for Alzheimer’s – a disease that affects 343,000 people in Australia, and 50 million worldwide – it’s been a race to figure out how best to treat it, starting with how to clear the build-up of defective beta-amyloid and tau proteins from a patient’s brain. Now a team from the Queensland Brain Institute (QBI) at the University of Queensland have come up with a pretty promising solution for removing the former.
Publishing in Science Translational Medicine, the team describes the technique as using a particular type of ultrasound called a focused therapeutic ultrasound, which non-invasively beams sound waves into the brain tissue. By oscillating super-fast, these sound waves are able to gently open up the blood-brain barrier, which is a layer that protects the brain against bacteria, and stimulate the brain’s microglial cells to activate. Microglila cells are basically waste-removal cells, so they’re able to clear out the toxic beta-amyloid clumps that are responsible for the worst symptoms of Alzheimer’s.
The team reports fully restoring the memory function of 75 percent of the mice they tested it on, with zero damage to the surrounding brain tissue. They found that the treated mice displayed improved performance in three memory tasks – a maze, a test to get them to recognise new objects, and one to get them to remember the places they should avoid.
“We’re extremely excited by this innovation of treating Alzheimer’s without using drug therapeutics,” one of the team, Jürgen Götz, said in a press release. “The word ‘breakthrough’ is often misused, but in this case I think this really does fundamentally change our understanding of how to treat this disease, and I foresee a great future for this approach.
The team says they’re planning on starting trials with higher animal models, such as sheep, and hope to get their human trials underway in 2017.
You can hear an ABC radio interview with the team here.
That would be perfect since that would be about the time she will have to come off RVT-101 and I would not mind if we had to live in Austraila for awhile. We are planning a Half Marathon in nearby New Zealand next November.