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Clinical Trial Participation for Dementia Treatments: Q & A with Dr. Lombardo

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November 10, 2016

Have you ever considered signing your loved one up for a clinical trial? There are many opportunities to do so, and clinical trials are critical to advancing research for dementia treatments. CaregiverStress.com® had the opportunity to speak with Dr. Ilise Lombardo of Axovant Sciences, Inc. to learn about her work in medical research and the importance of patient and caregiver participation in clinical research. 

Q. What is your background and experience with Alzheimer’s/dementia?

A. I’m a psychiatrist by training. For many years, I was at Columbia University and in private practice. I also served as an investigator in many clinical studies. For the past 14 years, I’ve worked in clinical research at pharmaceutical development companies, and have led the clinical development of several research programs focused on central nervous system disorders, including Alzheimer’s disease. Currently, I’m the Senior Vice President of Clinical Research at Axovant Sciences, where I am overseeing the clinical development of intepirdine (RVT-101), an investigational treatment for both Alzheimer’s disease and dementia with Lewy bodies.

Q. We know that there is no known way to cure or prevent Alzheimer’s disease. But there are ways to treat the symptoms. What are some of the treatments available?

A. The medications that have been approved by the FDA for the treatment of Alzheimer’s disease can improve patients’ cognition and ability to perform daily living activities. The most commonly used treatment is a medicine called donepezil (sometimes known as Aricept®), which is part of a category of medicines called cholinesterase inhibitors. Cholinesterase inhibitors focus on reducing the breakdown of acetylcholine, an important neurotransmitter in the brain that is deficient in patients with dementia.

Q. Can you tell us more about the treatment your team is developing?

A. As I mentioned earlier, intepirdine (RVT-101) is being evaluated in two separate clinical studies—one for treatment of mild-to-moderate Alzheimer’s disease (called the MINDSET study) and one for dementia with Lewy bodies (called the HEADWAY-DLB study). Intepirdine (RVT-101) is being developed as a once-daily oral tablet (no IV infusions or MRI monitoring is required), and has been studied in 15 previous clinical trials.

In the MINDSET study, intepirdine (RVT-101) is being evaluated as a potential add-on therapy to donepezil. The MINDSET study will evaluate whether intepirdine on top of donepezil can improve cognition and function in patients with mild-to-moderate Alzheimer’s disease.

Q. Who’s qualified to participate in a clinical trial?

A. Each clinical study has its own set of criteria and requirements for participation. Those who are interested in clinical trial participation will go through a screening process to see if they qualify for that particular study. In the case of the MINDSET study, the potential participant must have mild-to-moderate Alzheimer’s disease, be between 50 to 85 years of age, be on a stable dose of donepezil (Aricept®), and have a caregiver (a spouse, family member, friend or professional care provider) who is able to attend study visits and provide feedback to the study doctor about how the person is functioning on a daily basis. Those interested in seeing if they or a loved one qualify for MINDSET can take a brief pre-screening questionnaire at  www.AlzheimersGlobalStudy.com.

Another valuable resource for those interested in participating in clinical trials is www.clinicaltrials.gov, a government database of ongoing clinical studies.

Q. Why should people consider participating in a clinical trial? 

A. There are a variety of reasons that people choose to participate in a clinical study. Participants may receive investigational medications that are only available in clinical studies. Participants also receive study-related medical care from physicians with specialized experience in that area.  But most importantly, research participation is an important part of advancing scientific progress.  All FDA-approved medicines today are only available because volunteers in the past stepped forward to participate in clinical research.  It is also important to note that clinical trials are closely monitored by both regulators and independent ethics committees to protect and maintain the safety of participants.

Q. What’s expected of someone participating in a study? Cost? Time investment?

A. Each study involves a unique set of participation requirements, so it’s important for potential participants to learn about the details of the particular study they are considering, and discuss these details with their physician.  Generally speaking, there is no cost to participate, and participants do not need insurance. Participants will also attend study visits for certain assessments and see their study doctor.

In the case of the MINDSET study, participants will attend 9 study visits (including a screening visit) over approximately 6 months. During this time, participants will receive either the investigational medication or a placebo pill (a study drug look-alike without any active study ingredients). Neither the participants nor the study physicians will know whether they are taking the investigational medication or placebo.  All participants who complete the MINDSET study are eligible for a one-year open-label extension study in which all participants will receive the investigational medication.

Q. What’s your outlook on the road to a cure for Alzheimer’s and dementia?

A. Alzheimer’s and dementia has been a challenging area for developing new medicines.  No new chemical entity has been approved for the treatment of Alzheimer’s disease in 13 years.  For dementia with Lewy bodies, the second most common form of dementia, there are no approved treatments in the United States or Europe.

Today, there are several investigational medicines for the treatment of Alzheimer’s, including intepirdine (RVT-101), in various stages of clinical development. Though none of these drugs is likely to be a cure for the disease, my hope is that the future of Alzheimer’s treatment will be in combination therapy, where multiple drugs that work in different ways can be taken simultaneously, having a greater impact than any one drug individually.  Combination therapy has turned several previously fatal conditions into chronic but manageable conditions (for example, diabetes). I am hopeful that this is where we may be headed with Alzheimer’s disease and dementia, as well.

Additional resources for more information about clinical trial participation:

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