Leah Kuntz

No scientific studies support the claim that Blue Monday, the third Monday of January, is the saddest day of the year. Where did this myth come from?

In 2005, Cliff Arnal, a Welsh psychologist, came up with a 

 for the most depressing day of the year to use for a holiday travel company, Sky Travel. Factors included weather conditions, debt levels, time passed since Christmas, low motivation levels, and failing New Year’s resolutions. However, this seemingly harmless marketing tactic meant to sell summer vacations grew far beyond its original purpose. Unfortunately, it became, as Arnal dubbed it, “a self-fulfilling prophecy.”

Now, Dr Arnal has changed his tune drastically, apologizing for his formula, and even calling himself an “Activist to #StopBlueMonday” in his 

“These types of formulae, if anything, probably serve to oversimplify the complexities of real-life experience,” an anonymous spokesperson related to NBC News.

While it may not be scientifically proven, Dr Arnal’s idea of a gloomy post-holiday low point may carry some weight. Shorter days and cold temperatures can negatively affect mood and lead to 

 In the UK, up to a third of the population experiences SAD.

 Wintertime body changes can affect hormones, sleeping habits, eating habits, and mood.

Blue Monday may have caused an extra sense of dread to hang around January, especially for patients with depression and anxiety. They may feel pressure to overcome this particular sad holiday.

 To combat this pressure, AXA PPP Health came up with 7 ways to help boost morale and motivation.

-Identify the reason behind any lack of motivation

These simple strategies may help you or your patients stay positive not just on Blue Monday, but for all of the winter months.

1. Cohut M. The truth about ‘Blue Monday.’ 

. January 21, 2019. Accessed January 18, 2021. 

https://www.medicalnewstoday.com/articles/324236

2. Carlile J. Jan. 24 called worst day of the year. 

. January 21, 2005. Accessed January 18, 2021. 

https://www.nbcnews.com/id/wbna6847012#.XEW54M_7SqA

3. Katz D. Blue Monday isn’t real but winter’s impact on your mood can be. 

. Updated January 20, 2020. Accessed January 18, 2021. 

https://www.wbir.com/article/news/health/blue-monday-isnt-real-but-winters-impact-on-your-mood-can-be/51-5351a7e7-50fc-4987-a004-73ddb3d27a7c

4. What does Blue Monday mean for our mental health? 

. January 6, 2021. Accessed January 18, 2021. 

https://www.mentalhealth.org.uk/blog/what-does-blue-monday-mean-our-mental-health

5. Dorsey K. Seven ways fed-up workers can beat Blue Monday. 

. January 12, 2018. Accessed January 18, 2021. 

https://www.insider.co.uk/news/blue-monday-2018-january-15-11840132

Articles

Is the purported “saddest day of the year” evidence-based?

The Myth of Blue Monday

In an attempt to remove a potential barrier to opioid use disorder (OUD) treatment, the Department of Health and Human Services (HHS) announced a plan

Organizations like the American Medical Association (AMA) welcomed the revision. Patrice Harris, MD, chair of the AMA’s Opioid Task Force and the organization’s immediate past president, said the following in the AMA’s released statement: “With this change, office-based physicians and physician-led teams working with patients to manage their other medical conditions can also treat them for their opioid use disorder without being subjected to a separate and burdensome regulatory regime.”

The newly unveiled practice guidelines include an exemption from current certification requirements. The exemption applies to physicians already registered with the Drug Enforcement Administration.

The new HHS policy potentially limits physicians to treating no more than 30 patients with buprenorphine for OUD at any single time. The HSS will make exceptions to this limit for hospital-based physicians, such as those working in emergency departments.

Additionally, the policy change only applies to the prescription of drugs or formulations covered under the X-waiver of the Controlled Substance Act, such as buprenorphine. It does not apply to methadone. The effectual date of the new guidelines will be added after publication in the Federal Register.

The X-waiver has received criticism for years, with one group of doctors writing a 2018 Viewpoint article in 

, titled “Buprenorphine Deregulation and Mainstreaming Treatment for Opioid Use Disorder: X the X Waiver.”

 Deregulating buprenorphine, in the opinion of the authors, might be a way to mainstream an effective treatment for OUD.

“Federal policies surrounding buprenorphine constrain its wider use through separate US Drug Enforcement Agency (DEA)–amended licenses (‘waivers’) after approved training,” wrote Fiscella et al. “Removing buprenorphine prescribing regulations in France yielded increases in its use by persons with OUD. Notably, deaths from opioid overdoses in France declined 79% over the subsequent 3 years.”

By removing this waiver, the HHS has hopefully taken a step toward reducing opioid overdose in the United States.

1. Department of Health and Human Services. Announcement of practice guidelines for the administration of buprenorphine for treating opioid use disorder. January 12, 2021. Accessed January 18, 2021. 

https://www.hhs.gov/sites/default/files/mat-physician-practice-guidelines.pdf

2. Young KD. HHS will drop buprenorphine waiver rule for most physicians. 

https://www.medscape.com/viewarticle/944208

3. Fiscella K, Wakeman SE, Beletsky L. Buprenorphine deregulation and mainstreaming treatment for opioid use disorder: X the x waiver. 

The Department of Health and Human Services moves to reduce administrative procedural barriers to OUD treatment. 

Dropping the X-Waiver for Buprenorphine

In an award-winning study, researchers from The University of Texas Health Science Center at Houston (UTHealth) discovered a gene signaling pathway linked to a higher risk for developing schizophrenia by observing human-induced pluripotent stem cells created from blood samples of a single family. The pathway, phosphoinositide 3-kinase/glycogen synthase kinase 3 (PI3K/GSK3), contains differentially expressed genes, including serum-glucocorticoid kinase 1 (SGK1). This is an inhibitor of GSK3 beta and has been associated with schizophrenia.

“We believe this has direct implications for the treatment of patients,” senior author Consuelo Walss-Bass, PhD, MD, said to the press. “There is a new antipsychotic that just received approval from the Food and Drug Administration that directly targets the pathway we identified as dysregulated in neurons from the patients, and several other antipsychotics also target this pathway. This could help pinpoint who may respond better to treatments.”

Walss-Bass, the first author, and postdoctoral research fellow Laura Stertz, PhD, took blood samples from members of a large Costa Rican family with multiple individuals with schizophrenia. The blood cells were changed into stem cells using human-induced pluripotent stem cell (hiPSC) technology. These cells were then redirected to become brain neurons. This allowed them to be studied in a virtual biopsy and compared to neurons from family members who did not have schizophrenia.

In the biopsies, researchers saw 5 schizophrenia candidate genes previously identified by genome association studies. Alterations caused by gene SGK1, which inhibits GSK3 activity, are linked to whether a person has a higher risk of schizophrenia.

Walss-Bass had this to say on the discovery: “Mental health research has lagged behind because we don't know what is happening biologically. We are diagnosing people based on what they are telling us. Even postmortem, the brain tissue in mental health disorders looks perfectly fine. In Alzheimer disease, you can see a difference compared to controls. But not in psychiatric disorders. Now by studying virtual brain biopsies, we can tell what is happening biologically.”

Walss-Bass also said that identifying patients with specific biological pathway markers could identify them as the best candidates for medications. This pre-emptive, personal pharmacology may be what is needed to best treat psychiatric disorders.

“We were able to find significant, meaningful differences with a small control group,” Walss-Bass said. “Neurons of patients with schizophrenia had alterations in the signaling pathway. This research may help to understand how or why some antipsychotics targeting GSK3 work and also to develop other target-specific medications.”

1. Stertz L, Di Re J, Pei G, Fries G, et al. Convergent genomic and pharmacological evidence of PI3K/GSK3 signaling alterations in neurons from schizophrenia patients. 

2. University of Texas Health Science Center at Houston. Gene pathway linked to schizophrenia identified through stem cell engineering. News release. 

https://www.sciencedaily.com/releases/2020/12/201221134136.htm

Researchers have discovered a gene signaling pathway associated with a higher risk for developing schizophrenia. 

Gene Pathway Linked to Development of Schizophrenia

A Polish study seeking to understand the potential association between lifestyle choices and schizophrenia observed a significant relationship between reported habits and severity of schizophrenia symptoms. According to researchers, patients with schizophrenia who eat poorly, have insufficient physical activity, and use nicotine are at increased risk for lifestyle diseases, such as hypertension, obesity, and type 2 diabetes.

From 2011 to 2016, the study enrolled 106 participants with schizophrenia, 42 male and 64 female, aged 18 to 69 years. Many of these patients were recruited from inpatient and outpatient psychiatric facilities and wards at the Department of Psychiatry of the Pomeranian Medical University in Szczecin (Poland). Patients were evaluated using the Positive and Negative Syndrome Scale (PANSS), and completed a survey that gathered additional information, like their illness duration, selected eating habits, sweet beverage consumption, nicotine use, and physical activity in the last 3 months.

Increased physical activity was correlated with a reduced total PANSS score, improved negative and general symptomatology, and improvement of the lipid profile and blood glucose levels. Participants’ physical activity was gauged using a 3-point scale: 1 for low physical activity (sedentary), 2 for moderate activity (physical for daily routines), and 3 for intense activity (physical activity at least 3 times per week for more than 30 minutes). The study did not seek to cause any lifestyle-changing interventions, and patients did not receive lifestyle education at any time during the study’s duration. However, patients were allowed to view their laboratory test results and were free to consult a general practitioner or psychiatrist.

Significant adverse effects of smoking on metabolic parameters were observed, particularly on the lipid profile values; however, there is also evidence that smokers had significantly lower PANSS scores within the 

. This may be related to the relationship between smoking and the use of antipsychotics.

Researchers also noted an interesting development; while lifestyle education was not offered, many patients changed their behavior after completing the questionnaires. Positive change was noted in the number of cigarettes smoked per day, consumed coffee and sodas, and especially intake of sugar and sweets. Male participants especially were observed to consume significantly higher amounts of sweets and sweet beverages than their female counterparts, but many cut back on sweets and sodas after their follow-up.

There are clear benefits to providing educational interventions on physical activity and proper eating habits to patients with schizophrenia, especially since, “physical activity and exercise are now recognized as fundamental tools for reducing the impact of chronic diseases…”

 Both mental and physical outcomes could be improved for these patients.

Negative Symptoms in Schizophrenia: Etiology, Hypotheses, and Treatment Implications.

1. Kalinowska S, Trześniowska-Drukała B, Kloda K, Safranow K, et al. The association between lifestyle choices and schizophrenia symptoms. 

2. Belvederi Murri M, Ekkekakis P. Can exercise decrease mortality risk in patients with depression? 

Improving physical activity levels and eating habits could help patients with schizophrenia.  

Risk of Lifestyle Diseases for Patients with Schizophrenia

The Accelerated Development of Additive Pharmacotherapy Treatment for Methamphetamine Use Disorder study, or ADAPT-2 study, discovered that a combination of injectable naltrexone and oral bupropion was safe and effective for treating adults with moderate to severe methamphetamine use disorder. This combination therapy may be a potential treatment addition for those struggling to overcome addiction to methamphetamine.

“The opioid crisis and resulting overdose deaths in the United States are now well known, but what is less recognized is that there is a growing crisis of overdose deaths involving methamphetamine and other stimulants. However, unlike for opioids, there are currently no approved medications for treating methamphetamine use disorder,” National Institute on Drug Abuse (NIDA) Director Nora D. Volkow, MD, said to the press. “This advance demonstrates that medical treatment for methamphetamine use disorder can help improve patient outcomes.”

The research was conducted from 2017 to 2019 at multiple sites within the NIDA Clinical Trials Network (NIDA CTN). The study enrolled 403 adult participants aged 18 to 65 years with moderate to severe methamphetamine use disorder for stage 1, and 225 participants in stage 2. All of these participants wanted to reduce or cease use of the drug.

The study was broken down into 2 stages, 6 weeks each. Participants in the treatment group were given an injection of extended-release naltrexone every 3 weeks and extended-release tablets of bupropion daily. Participants in the control group were given injectable and oral placebos over the same time periods. Adverse events within the naltrexone–bupropion treatment group included gastrointestinal disorders, tremor, malaise, hyperhidrosis, and anorexia. Serious adverse events occurred in 8 of 223 participants who received naltrexone–bupropion during the trial.

At the end of each stage of the trial, researchers gave 4 urine drug screens. If at least 3 of the 4 urine screens were negative, the participant was considered to have responded to treatment.

Over a 12-week period, responses among participants who received extended-release injectable naltrexone plus oral extended-release bupropion was low; however, it was higher than that of the participants who received placebo.

“Long-term methamphetamine misuse has been shown to cause diffuse changes to the brain, which can contribute to severe health consequences beyond addiction itself,” trial leader Madhukar H. Trivedi, MD, of the University of Texas Southwestern Medical Center, Dallas, said to the press. “The good news is that some of the structural and neurochemical brain changes are reversed in people who recover, underscoring the importance of identifying new and more effective treatment strategies.”

1. National Institutes of Health. Combination treatment for methamphetamine use disorder shows promise in NIH study. News release. January 13, 2021. 

https://www.nih.gov/news-events/news-releases/combination-treatment-methamphetamine-use-disorder-shows-promise-nih-study

2. Trivedi MH, Walker R, Ling W, dela Cruz A, et al. Bupropion and naltrexone in methamphetamine use disorder. N Engl J Med. 2021;384:140-153.

In an ADAPT-2 study, a combination of injectable naltrexone and oral bupropion showed promise for methamphetamine users.  

Medicine Combination With the Potential to Beat Methamphetamine Use Disorder

Teva Pharmaceuticals and MedinCell announced positive results for the risperidone subcutaneous extended-release study (RISE study), a phase 3 clinical trial evaluating the efficacy of risperidone extended-release injectable suspension for subcutaneous use as a treatment for patients with schizophrenia.

“Schizophrenia is a chronic, progressive and severe mental disorder in which every relapse has the potential to cause cognitive and psychosocial loss, worsen long-term outcomes, and increase the overall burden for patients, caregivers, families, and the healthcare system. We are encouraged by the results of the RISE study, which demonstrated a marked delay in time to relapse for patients in both the monthly and once-every-two months treatment groups,” Christer Nordstedt, MD, PhD, Senior Vice President, Head of Specialty Clinical Development at Teva said to the press. “We look forward to sharing more detailed results from the RISE study at future scientific conferences, in peer-reviewed publications as well as exploring options for a potential NDA submission using the currently available clinical data.”

Trial enrollment was open to participants 13 to 65 years of age. Those treated with the investigational subcutaneous risperidone injection either monthly or once every 2 months experienced a statistically significant delay in time to relapse compared to participants who received the placebo.

“Long-acting injectables (LAI) for schizophrenia are considered to be an innovative treatment option that we believe will make a meaningful difference, yet they tend to be underutilized and only introduced late in the course of the disease,” said MedinCell CEO Christophe Douat. “The results of the RISE study are promising and point to the potential for risperidone to be a subcutaneously administered treatment option for patients with schizophrenia.”

Teva intends to continue leading the clinical development and regulatory process, as well as maintaining responsibility for commercialization of this treatment.

1. Teva Pharmaceuticals Industries. Teva and MedinCell Announce Positive Results for Registration Trial of Investigational Extended-Release Subcutaneous Injectable Risperidone for Patients with Schizophrenia. News release. 

https://www.businesswire.com/news/home/20210107005469/en/Teva-and-MedinCell-Announce-Positive-Results-for-Registration-Trial-of-Investigational-Extended-Release-Subcutaneous-Injectable-Risperidone-for-Patients-with-Schizophrenia

Positive Results From Trial of Risperidone Injectable Schizophrenia Treatment

Major psychiatric organizations like the American Psychoanalytic Association (APsaA) and the American Psychiatric Association (APA) have condemned the violence that took place in Washington DC on January 6th.

“The past few days in Washington have been among the most disturbing in our lifetimes, and arguably in American political history. What we witnessed on January 6th—with horror and sadness—was an attack on the most precious institutions that symbolize our form of government and constituted an assault on democracy itself,” APsaA president William Glover, PhD and president-elect Kerry Sulkowicz, MD, said in a 

APA CEO and Medical Director Saul Levin, MD, MPA, furthered this sentiment in his statement: “We, as psychiatrists, are deeply concerned and angered by the violence that has occurred and that may continue in our communities. If you are feeling anxious or unsafe, talk with your family and friends. If your feelings continue and it is impacting your daily life, do not hesitate to seek help through your primary care provider, a psychiatrist or other mental health professional, or other resources in your community.”

In the APA’s statement, attention was called to the differences in treatment of Black Lives Matter protesters and those who stormed the Capitol: “The stark contrast between the government’s response to Black Lives Matter protesters during the summer and fall, a significant proportion of whom were Black, and its response to mostly white MAGA protesters yesterday, is deeply concerning.”

The APsaA statement condemned President Trump’s involvement and called for his removal: “This is beyond politics. After refusing to concede that he had lost the election, President Trump sparked an insurrection, inciting a mob to storm the US Capitol. We have long believed that Trump is a dangerous leader, as evidenced by his encouraging right-wing extremists in Charlottesville, Portland, and Kenosha, and his behavior this week makes this apparent to all. The combination of his publicly evident psychopathology and the power of the office he holds constitutes a clear and present danger to the health and well-being of the nation and its people. We support his immediate removal from office, by resignation, impeachment or invoking the 25th Amendment to the Constitution.”

For those worried about how to console patients or bring hope, the APA offered a few resources, which are provided below.

Those who need immediate assistance can utilize the following hotlines:

 Call 800-950-6264 Monday through Friday, 10AM – 6PM, ET

 page on the APA website may also be useful, as it lists common reactions and helpful steps for overcoming trauma responses.

1. American Psychoanalytic Association. ‘Trump is a Dangerous Leader,’ APsaA Calls for Removal. News release. January 8, 2021. 

https://apsa.org/content/trump-dangerous-leader-apsaa-calls-removal

2. American Psychiatric Association. APA Statement on Yesterday’s Violence in Washington. News release. January 7, 2021. 

https://www.psychiatry.org/newsroom/news-releases/apa-statement-on-yesterday-s-violence-in-washington

Major psychiatry organizations condemn the actions and events of January 6th.

Psychiatry Responds to the Violence at the Capitol

BioXcel Therapeutics recently announced that its orally dissolving, thin-film formulation of dexmedetomidine, BXCL501, met the primary and secondary endpoints of the TRANQUILITY trial at the 60 mcg dose level.

“We are very encouraged by the promising topline results from the TRANQUILITY study, which was designed to identify a recommended dose of BXCL501 for a potential pivotal study in dementia patients suffering from agitation. Following decades of research, there are still no effective treatments that directly target agitation commonly seen with dementia patients, and we are thrilled by the potential of being the first to develop a therapy designed to address this significant patient and caregiver need,” Vimal Mehta, Chief Executive Officer of BioXcel, said to the press. “Based on the results observed, we believe BXCL501 has broad potential in treating the full spectrum of agitation in patients with dementia. We look forward to advancing BXCL501 into a late-stage study this year following dialogue with the FDA.”

BXCL501 is a selective alpha-2a receptor agonist for the treatment of agitation and opioid withdrawal symptoms. BioXcel believes that BXCL501 directly targets an agitation mechanism and has observed anti-agitation results in a number of clinical studies across several neuropsychiatric disorders.

The US Food and Drug Administration (FDA) granted BXCL501 Fast Track Designation for the acute treatment of agitation in patients with schizophrenia, bipolar disorders, and dementia. Two different phase 3 trials (SERENITY I and II) studied BXCL501 for the acute treatment of agitation associated with schizophrenia and bipolar disorders.

The TRANQUILITY study consisted of 54 participants in assisted living facilities with agitation related to dementia, 87% of whom had Alzheimer disease. Participants received BXCL501 at either 30 mcg, 60 mcg, 90 mcg, or a placebo. Participants reported no severe or serious adverse events, and the primary safety and tolerability endpoints were met. Adverse events in the trial included hypotension, orthostatic hypotension, and dizziness, with the most common adverse event being mild or moderate somnolence.

BioXcel also shared plans for a phase 2 trial studying hospitalized patients who have agitation symptoms associated with delirium, intended to begin within the next several months.

1. BioXcel Therapeutics. BioXcel Therapeutics announces BXCL501 met the primary and all secondary endpoints in the TRANQUILITY phase 1b/2 study for the acute treatment of agitation in dementia, including Alzheimer disease. News release. 

https://www.globenewswire.com/news-release/2021/01/05/2153316/0/en/BioXcel-Therapeutics-Announces-BXCL501-Met-the-Primary-and-All-Secondary-Endpoints-in-the-TRANQUILITY-Phase-1b-2-Study-for-the-Acute-Treatment-of-Agitation-in-Dementia-including-Al.html

A new formulation of dexmedetomidine meets primary and secondary endpoints in recently completed study. 

Medication for Agitation in Dementia and Alzheimer Disease Patients Moves Forward

Biohaven Pharmaceutical Holding Company recently announced the start of a pivotal phase 3 clinical trial. It will assess the efficacy and safety of troriluzole for the treatment of obsessive-compulsive disorder (OCD).

“We look forward to advancing our Phase 3 clinical trials of troriluzole 280 mg for the adjunctive treatment of OCD. If approved, this would provide hope to many who suffer with OCD and for whom standard of care medications do not provide adequate relief. No new treatments for OCD have been approved for over two decades. With its novel mechanism of action compared to currently available therapies, troriluzole would provide a significant advance in treatment for the many patients who either do not respond or continue to experience residual symptoms with standard medications,” Elyse Stock, MD, Chief Medical Officer at Biohaven said to the press.

Biohaven decided to advance the 280 mg once-daily dose of troriluzole into 2 identical, study-designed phase 3 clinical trials. They plan to enroll approximately 600 patients in each of these trials across study sites in both the United States and Europe. The recently completed phase 2 trial (a proof of concept study) showed clinically meaningful effects at all study timepoints in patients who had an inadequate response to standard treatment. While the study sample size in the phase 2 trial did not demonstrate statistical significance, the data was instrumental in refining the phase 3 studies.

“We are excited to begin these new studies as approximately one third of patients with OCD do not respond to currently available medications and new therapies are urgently needed. We believe troriluzole, which normalizes neuronal glutamate, could offer a promising alternative treatment with a new mechanism of action for OCD sufferers who are not adequately responding to currently available treatments,” Loren Aguiar, MD, Vice President of Research and Development and Biohaven said to the press.

Troriluzole is a new chemical entity and modulating agent that normalizes glutamate. Biohaven was awarded 2 US patents covering troriluzole, and international patents are pending. All the patents have statutory expiration dates in 2039.

The executive director of the International OCD Foundation, Jeff Szymanski, PhD, had this to say: “There is a significant need for new treatments for those suffering from OCD. We applaud Biohaven for their ongoing research and moving forward with these upcoming trials.”

1. Biohaven. Biohaven begins pivotal phase 3 trial of troriluzole in obsessive-compulsive disorder. News release. January 4, 2021. 

https://www.biohavenpharma.com/investors/news-events/press-releases/01-04-2021

A new phase 3 trial recently started for the novel treatment troriluzole.  

Developments in Trials of a New OCD Treatment 

A pair of trials related to Alzheimer disease recently released big news: NovoNordisk decided to move its recently launched type 2 diabetes drug semaglutide into a phase 3 study, and AB Science SA shared the results from a phase 2B/3 study evaluating masitinib in Alzheimer disease.

NovoNordisk’s type 2 diabetes (T2D) drug, semaglutide, will be the first-to-market oral GLP-1RA in T2D. However, after the large number of failures in Alzheimer disease trials in 2019, several key opinion leaders believe NovoNordisk will face a tough battle when entering into Alzheimer disease market.

Valentina Gburcik, PhD, Senior Director of Cardiovascular and Metabolic Diseases, Gender Health and Digital at GlobalData, had this to say on semaglutide: “Due to the growing unmet needs in the Alzheimer’s space, which has not seen any major medical breakthroughs over the past decade, and the increasing evidence of a potential therapeutic role for GLP-1, oral semaglutide may be able to secure its position in a yet another lucrative market if found to be efficacious in challenging Alzheimer’s clinical trials. However, the drug may face fierce competition from a number of novel therapies entering the Alzheimer’s market over the next several years.”

On the topic of masitinib, AB Science SA presented data confirming that masitnib’s mode of action has a potential synergistic effect and 4 targets. The 4 targets of masitinib in Alzheimer disease are:

1. Modulation of microglia: masitinib modulates microglia activity through inhibition of the CSFR-1 kinase and is involved in the neuroinflammatory processes commonly associated with Alzheimer disease.

2. Protecting synapses: Alzheimer disease alters synapses, and masitinib has been shown to promote recovery of synaptic markers in mouse models.

3. Inhibiting the tau protein: masitinib inhibits the FYN kinase, a kinase that mediates tau phosphorylation, and also prevents the accumulation of amyloid fibrils in the hippocampus, as shown in mouse models.

4. Control of mast cell activity: masitinib blocks mast cells activity through inhibition of the c-Kit, LYN, and FYN kinases. Mouse models showed that mice depleted of mast cells do not develop symptoms of Alzheimer disease.

In a transgenic mouse model, masitinib was able to restore cognitive impairment and restore ability to perform navigation strategy in the Morris Water Maze experiment. It could also exert a neuroprotective effect against synaptic loss.

“Study AB09004 was a well-designed phase 2b/3 as it compared masitinib on top of standard of care treatment versus the standard of care. These data are very encouraging and may provide new hope for patients with Alzheimer’s disease,” Bruno Dubois, MD, PhD, professor of neurology at the Neurological Institute of the Salpétrière University Hospital at Paris and coordinating investigator of the study, said to the press.

These announcements point to big changes on the horizon for the treatment of Alzheimer disease. Further discoveries and products will hopefully bring clinicians and researchers a step closer to a cure. 

1. GlobalData. NovoNordisk’s Rybelsus a game changer in T2D but may face a tough road ahead as it strides into Alzheimer’s space. News release. December 18, 2020. 

https://www.globaldata.com/novonordisks-rybelsus-game-changer-t2d-may-face-tough-road-ahead-strides-alzheimers-space/

2. AB Science. AB Science communicates the results from phase 2B/3 study evaluating masitinib in Alzheimer’s disease. News release. 

https://www.globenewswire.com/news-release/2020/12/18/2147549/0/en/AB-Science-communicates-the-results-from-phase-2B-3-study-evaluating-masitinib-in-Alzheimer-s-disease.html

New developments in Alzheimer disease treatment and research. 