My Alzheimer's Journey
Part 139 - Masupirdine for Agitation in People With Alzheimer's Disease
According to the Alliance for Aging Research, about half (44.6%) of people living with Alzheimer’s disease (AD) develop agitation behavior. Many of you face agitation behaviors all too often while caring for your loved one. I wrote caregiver tip’s for dealing with agitation a few weeks ago. Today, let’s talk about medication to help control agitation behaviors - especially, a promising new drug entering phase 3 trial.
You may be surprised to know that agitation is a separate, but related condition to AD.
Agitation behaviors fall into the category of neuropsychiatric symptoms. In addition to agitation behaviors, mood disorders, psychosis, and sleep disturbances are classified as neuropsychiatric symptoms. Since these symptoms differ from cognitive decline and memory loss, they have to be treated separately from AD.
In recent years, a few drugs have been used to treat agitation behaviors in people diagnosed with AD. One of those drugs is Citalopram (brand name is Celexa). Citalopram is used to treat depression. A 2013 clinical trial and subsequent follow-up studies reported “patients with mild cognitive impairment and moderate agitation are most likely to benefit” from Citalopram. Significant side effects and safety concerns were reported.
The first drug approved by the FDA to treat agitation that may occur with AD patients is Brexpiprazole (brand name is Rexulti). Two 12-week clinical trials with patients aged 55 to 90 with agitation behaviors and AD, experienced a “greater improvement in their symptoms of agitation compared with those who took a placebo” The most common side effects include weight gain, sleepiness, dizziness, common cold symptoms, and restlessness.
There is a new experimental drug entering Phase 3 trials. Developed by Suven Life Sciences, Masupirdine (SUVN-502) is a pure, potent, and orally active serotonin blocker.
Serotonin (5-HT) is an important neurotransmitter that is found in both the central and peripheral nervous systems. As a reminder, neurotransmitters are chemical messengers that allow neurons to communicate with other cells (nerves, muscles, glands) across synapses, regulating vital functions like heart rate, sleep, mood, and movement. There are seven different 5-HT receptor families. One of those families, 5-HT6 has been studied for many years as a possible effective treatment for cognitive decline. Masupirdine is a 5-HT6 receptor antagonist or blocker.
Pre-clinical studies of Masupirdine using Swiss Albino mice showed potential beneficial effects on agitation. While the Phase 2 study did not meet its primary end point, it showed “significantly reduced agitation/aggression in patients with baseline symptoms.” This study combined Masupiridine with Donepezil and Memantine. Both of these drugs are commonly used to improve cognition in AD and other dementia patients. The Phase 2 trial concluded that Masupirdine had “durable efficacy for the entire study duration of 26 weeks.” Suven Life Sciences reported that Masupirdine was well tolerated and safe.
A meta-analysis has been carried out to compare and rank the efficacy of Masupirdine, Zervimesine, sodium oligomannate, Donanemab, and Lecanemab on cognitive function in patients with mild AD and mild cognitive impairment. In the meta-analysis, Masupirdine showed some efficacy in improving cognitive function in patients with AD. This is interesting because Masupirdine may have secondary benefits beyond treating agitation behaviors.
Recruitment for a Phase 3 study is underway. This double-blind, randomized, placebo-controlled, parallel group, multicenter study will further evaluate the efface and safety of Masupirdine. About 375 Alzheimer patients from the USA and Europe will be recruited for the study. Study participants will receive either 50 mg or 100 mg Masupirdine or placebo for 12 weeks. I do not have an exact study start date. You should contact Suven by email at agitation@suven.com or by phone at 9140 2319 3956 for additional information.
Suven Life Sciences is based in Hyderabad, India. Operations began in the early 2000’s. I found it interesting that in 2003 they purchased used equipment from a pharmaceutical company in New Jersey, USA. While they currently have a handful of novel experimental drugs under developmental, they are also a contract drug developer and manufacturer, with capabilities in producing specialized formulations. They are a public stock corporation. From a business perspective, it seems that the contract work pays for the research of experimental drugs.
Positive results from the Phase 3 trial are critical for the future of Masupirdine. If it meets its goals, this new drug could be available in a year or two. For a small-ish pharmaceutical company, bringing Masupirdine to market would be an enormous win.
More importantly, the millions of people living with Alzheimer’s and experiencing agitation behaviors would have an additional treatment option.
Before I go, Linda’s left leg rehabilitation at the University of North Carolina hospital is going well. The current plan is for her to come home Sunday. Her physical therapy will continue at home next week. As the photos below show, Big Bit has stepped up to take care of me in Linda’s absence.
From the moment I began My Alzheimer’s Journey, I knew that I wanted to build a space that was free and accessible to everyone - a resource for the patients, caregivers, researchers, and medical professionals who need this information most.
As this community has grown, so have the costs of keeping it running. Between professional journal subscriptions, scientific research purchases, and the several hours of research and writing I put into every single post, the expenses have become significant. While I’ve received occasional donations in the past, they haven’t been consistent enough to cover these mounting costs.
To ensure this blog remains a high-quality resource for the long haul, I’ve decided to formalize how you can support this mission. There are three ways you can support the publication:
Sometimes: Donate whatever you can, whenever you can. You will continue to have full access to the entire blog - nothing changes for you, and your support is deeply appreciated.
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Sponsors (minimum donation of $40/month): You’ll receive all the Supporter benefits plus a permanent 8% store discount and an invitation to a monthly live Zoom meeting. This will be an open space to talk, share, and ask me almost anything on your mind. I will schedule multiple times if needed to make sure our international friends can join in.
I never want a person’s financial situation to stand between them and the support they find here, but I also want to ensure My Alzheimer’s Journey is sustainable. If you’re able to, please consider contributing so I can continue to share insight with you and the many caregivers and families who are following My Alzheimer’s Journey.
Please support at the level that feels right for you. I am so grateful to have you alongside me on my Alzheimer’s journey.
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