Parkinson’s Disease Hallucinations Commercial

How Common Is Parkinson’s Disease Psychosis

Between 20-40% of people with Parkinsons report the experience of hallucinations or delusions. When followed as the disease progresses over the years, this number increases. The increase does not mean that the hallucinations are persistent across the majority of patients. However, it is important to note that these statistics sometimes include delirium, in which the symptoms are temporary due to medication that needs to be adjusted or infection that needs to be treated, and isolated minor symptoms or minor hallucinations, including illusions, where instead of seeing things that are not there , people misinterpret things that are really there. These are the most common types of psychosis in people with PD, with different studies placing the occurrence between 25-70% of people with Parkinsons. Typically, if the person with PD only has these minor hallucinations, their doctor will not prescribe an antipsychotic medication, though more significant psychosis that requires medication may develop over time. In one study, 10% of those with minor hallucinations had their symptoms resolved within a few years, while 52% saw their symptoms remain the same and 38% saw their psychosis symptoms get worse.

We recommend that people with Parkinsons not use a single percentage to represent the prevalence of hallucinations and PDP. Parkinsons is a complex disease and as it progresses the percentages and risk of symptoms will change.

What Causes Psychosis In Parkinsons

Currently, there is not a clear understanding of the exact cause of Parkinsons disease psychosis, although certain brain chemicals and receptors are believed to play a role. In general, the condition is believed to be caused by either one of the following:

Side effect of dopamine therapy:

Although an exact causal relationship has not been established, some believe that this condition may be a side effect of dopaminergic therapy .2Dopaminergic therapy increases dopamine levels, helping improve motor symptoms in patients with Parkinsons disease. However, increasing dopamine levels can also cause chemical and physical changes in the brain that inadvertently lead to symptoms such as hallucinations or delusions.

Natural outcome of the disease:

This condition can be triggered by changes in the brain that occur regardless of taking dopamine enhancing medication. Some of these changes occur naturally as Parkinsons disease progresses.2

Use In Specific Populations

Pregnancy and Lactation

No data are available regarding pimavanserin-induced major congenital malformations, miscarriage, or other birth defects in humans. In animal studies, no developmental effects were observed when oral pimavanserin was administered at up to 10 or 12 times the maximum recommended human dose of 34 mg daily to rats and rabbits, respectively. However, maternal toxicity and lower pup survival and body weight were reported following administration of two times the MRHD of pimavanserin to pregnant rats during pregnancy and lactation.

Pimavanserin has not been studied for excretion in human milk, the effects on the breastfed infant, or the effects on milk production. The manufacturer recommends weighing the risks versus the benefits of treatment prior to the initiation of pimavanserin during lactation.

Renal and Hepatic Impairment

Dose adjustment of pimavanserin in patients with mild-to-moderate renal impairment is not required, but use of the drug in patients with severe renal impairment or with any hepatic impairment is not recommended.

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Who Is At Risk For Psychosis

Theres no predicting with certainty which patients with Parkinsons disease will go on to develop symptoms like hallucinations or delusions. A number of risk factors both internal and external- are associated with the condition.Some of these risk factors include: age, duration and severity of Parkinsons disease and the taking of dopamine therapy.3-6

Clinical Evidence From Trials In Dementia

A phase II randomized, double-blind, placebo-controlled, single-center clinical trial assessed the safety and efficacy of pimavanserin 34 mg daily versus placebo for the treatment of AD psychosis. Completed in 2016, the study included 181 participants from multiple affiliated nursing-home sites across the United Kingdom . The primary endpoint was the mean change in the Neuropsychiatric Inventory-Nursing Home version psychosis score, from baseline to week 6. At week 6, patients in the pimavanserin group showed significant improvement in the NPI-NH psychosis score compared to patients in the placebo group. Mean change in the NPI-NH psychosis score from baseline at week 6 was 3.76 points for pimavanserin and 1.93 points for placebo . However, in this trial, a significant difference in efficacy between pimavanserin and placebo was not seen at 12 weeks of treatment . Although agitation was higher in patients receiving pimavanserin than in those receiving placebo , the overall adverse event profile was similar in the two groups. No detrimental effect was observed on cognition or motor function in either group .

Table 2 Summary of completed and ongoing clinical trials for pimavanserin in dementia-related psychosis.

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How Can I Tell If I Am Experiencing Hallucinations

Hallucinations are conscious processes that last a certain amount of time. You can talk about them with someone close to you when they occur.

To know if you are hallucinating, you need to be able to confront reality with your perception. You can do this verification yourself or with the help of someone close to you.

In any case, you have to be prepared to accept that your perception may have been tainted. Fortunately, these hallucinations are not related to Parkinsons disease progressing into a form of dementia. They usually disappear when you change your medications.

Speak to your neurologist. They will be able to do tests to evaluate the causes of your hallucinations and possibly review your medication dosages.

What Is Parkinsons Disease Psychosis

Parkinsons disease psychosis is a non-motor symptom of Parkinsons disease that causes patients to experience hallucinations and/or delusions.More than half of all patients with Parkinsons disease eventually develop symptoms over the course of their disease.1

Diagnosing and treating this condition can be complex. The condition relates to both neurology and psychiatry . For this reason, Parkinsons disease psychosis is considered a neuropsychiatric condition, since it deals with mental health symptoms caused by a disease of the nervous system .

Introducing an easier way to track your symptoms and manage your care.

Dont want to download the app? Use the non-mobile version here.

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Acadia Pharmaceuticals Reports First Quarter 2020 Financial Results

SAN DIEGO—-May 7, 2020–

ACADIA Pharmaceuticals Inc. , a biopharmaceutical company focused on the development and commercialization of innovative medicines to address unmet medical needs in central nervous system disorders, today announced its financial results for the quarter ended March 31, 2020.

ACADIA entered 2020 with positive momentum. Successful execution of our commercial efforts led to continued strong performance of NUPLAZID ® for Parkinsons disease psychosis and our plans remain on track for delivering a potential second indication with pimavanserin for the treatment of DRP. We also continue to invest in our late-stage pipeline and business development opportunities to shape our mid and long-term growth strategy, said Steve Davis, ACADIAs Chief Executive Officer. Our results this quarter reflect the dedication of our employees and I am proud of our teams commitment to the patients we serve while adapting to the challenges of the global COVID-19 pandemic.

Company Updates

• ACADIA completed a pre-sNDA meeting with the U.S. Food and Drug Administration and is on-track to submit a supplemental NDA this summer for pimavanserin as a potential breakthrough therapy for DRP.

• The FDA granted Rare Pediatric Disease designation to trofinetide for the treatment of Rett syndrome, a serious and rare neurological disorder.

Financial Results

Revenue

Research and Development

Selling, General and Administrative

Net Loss

Cash and Investments

2020 Financial Guidance

Selfcare For The Person With Parkinsons

• Join a Parkinsons support group if you dont already belong to one. Talk about your experiences, ask for help if you need it and share whats worked and not worked for you.
• Offer to have coffee with someone you know has been newly diagnosed and offer them support and encouragement.
• Make time to exercise and get out in nature every day.
• Communicate frequently with your doctors and discuss the possibility of tweaking your medications if your symptoms become worse.
• Rest when you need it.
• Plan a day trip or a vacation and get away from your normal surroundings.
• Take control where you can and keep authoring your own story.
• Practice meditation or yoga or Tai Chi to relax and calm your mind.
• Start a new project that youre excited to work on every day.
• Communicate with your care partners and let them know how they can best help you.

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I Had A Hallucination: What Next

Research has shown that for many people with PD who have them, hallucinations begin after a change in medication, more specifically, an increase in levodopa . Additional factors make a person more likely to experience hallucinations when medications are changed, such as other cognitive problems or memory issues, depression and sleep problems. Dementia|A term used to describe a group of brain disorders that cause a broad complex of symptoms such as disorientation, confusion, memory loss, impaired judgment and alterations in mood and personality.] also increases the risk of hallucinations and delusions when PD medications are changed. Dementia means cognitive changes whether in memory, judgment or attention that interfere with daily life.

One thing that does not affect the risk of hallucinations is your regular dose of levodopa. Rather, studies show that it is a change in dose an increase in a dose that has been stable that sets off hallucinations.

Tip: Experiencing a hallucination does not mean you are going crazy. Many people recognize that their hallucinations are not real. Do not react to these visions or sounds or engage them dismiss them. Bring up the topic with your doctor immediately.

This Antidepressant May Be No Better Than Cheaper Alternatives But Demand Could Soon Soar

Nuplazid, if given the FDA go-ahead, would undoubtedly cost far more than existing antipsychotics, which are mostly used to treat schizophrenia and are available as generics. In the pivotal trial behind Acadias marketing application, Nuplazid showed only modest improvements over placebo, and was tested in a way that makes it difficult to compare against other treatments.

Physicians involved in the trial stand by the drug, nonetheless.

Dr. Jeffrey Cummings, a neurologist at the Cleveland Clinic Lou Ruvo Center for Brain Health in Las Vegas, said he was struck by some of the patients dramatic responses.

Of course, families will also respond to placebos, and thats why we dont approve drugs based on anecdotal reports, said Cummings, who has taken consulting fees from Acadia. But when families are saying this really made a difference for his life and our lives together, for me it was a pretty impressive study.

Parkinsons psychosis usually occurs in the latter stages of the disease, and generally involves nonthreatening visual hallucinations. Cynthia Hatfield, a 72-year-old former banker living in Westerly, R.I., several times a week sees a calico cat resembling one shed actually owned many years ago, and which her children named Mushroom. For years, her hallucinations included a menagerie of small animals.

Chipmunks and little squirrels and cats, and a little mouse would come out every once in a while, she said. I actually enjoy seeing them.

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Drug Helped Dementia Patients Curb Their Hallucinations And Delusions

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A drug that curbs delusions in Parkinsons patients did the same for people with Alzheimers disease and other forms of dementia in a clinical trial that was stopped early because the benefit seemed clear.

If regulators agree, the drug could become the first offered specifically for treating dementia-related psychosis. It would also be the first new medicine for Alzheimers in nearly two decades.

The daily pill targets some of the most troubling symptoms that patients and caregivers face hallucinations that often lead to anxiety, aggression, and physical and verbal abuse.

Trial results were disclosed this week at an Alzheimers conference in San Diego.

This would be a very important advance, said one independent expert, Dr. Howard Fillit, chief science officer of the Alzheimers Drug Discovery Foundation.

Although the field is focused on finding a cure for dementia and preventing future cases, there is a huge unmet need for better treatment for those who have it now, said , chief science officer for the Alzheimers Assn.

The drug, pimavanserin, is sold as Nuplazid by Acadia Pharmaceuticals Inc. It was approved for Parkinsons-related psychosis in 2016 and is thought to work by blocking a brain chemical that seems to spur delusions.

About 8 million Americans have dementia, and studies suggest that up to 30% of them develop psychosis.

Current anti-psychotic medicines have some major drawbacks and are not approved for dementia patients.

Acadia Launches Parkinsons Campaign To Shine Light On Psychosis Symptoms

A new disease awareness campaign shines a light on the hallucinations and delusions that can affect half of people who have Parkinsons disease.

Sponsored by Acadia Pharmaceuticals, a TV ad and accompanying website focus on the common but lesser-known non-motor side effects of seeing and hearing things that arent real. Acadia is the only drugmaker with an approved treatment for the psychosis that can accompany Parkinson’s.

The darkly lit ad opens with a man talking about the secret visitors who appear to him and tell him stories that are only in my mind. The tone changes when a woman touches his shoulder and walks with him to a brightly lit window where visitors, including a young boy, are approaching. A narrator notes that more than 50% of Parkinsons patients will experience hallucinations or delusions that can worsen over time and encourages caregivers to seek help. The man in the ad greets the young boy and ends the ad with: My visitors should be the ones I want to see.

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Section Header Managing Psychosis With Medication

Dont keep hallucinations or delusions a secret from your doctor. Medications — or changes to the medications you take — can help manage Parkinsons psychosis.

Streamlining your meds. The first thing your doctor may want to do is stop or lower your Parkinsons medication dose. They may boost dopamine levels in your brain. That improves motor symptoms but can also cause changes in your emotions or the way you act.

Antipsychotics. These medications balance your brain chemicals. Only a few are considered safe for people with Parkinsons disease. These include quetiapine and clozapine .

Pimavanserin . Another antipsychotic, this first-in-class drug was approved by the FDA in 2016 to treat hallucinations and delusions in Parkinsons disease linked with psychosis.

If you see a doctor who isnt part of your usual care team — say, in the emergency room or an urgent care setting — tell them you have Parkinsons disease and what medications you take for it.

What Makes Some People With Parkinsons More Susceptible To Parkinsons Disease Psychosis

Not everyone living with Parkinsons will experience hallucinations and/or delusions, but there are several things that can increase your risk. Here are a few to look out for. Be sure to speak to your doctors and care partners if you notice any changes.

• Increased sleep disturbances such as REM Sleep Behavior Disorder, sleep apnea, vivid dreaming and sleep interruptions
• Vision problems such as blurry or double vision
• Hearing problems
• Aging
• Medication changes such as new medication, dosage changes and drug interactions
• Disease progression

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How To Care For Someone Who Experiences Delusions

If the person youre caring for experiences confusion or delusions, heres what you can do in the moment:

• Stay as calm and patient as you can and remember that this belief has nothing to do with you and only with what is going on in their mind
• Remove any objects in the room that could pose a danger to them or to anyone else
• Clear space so there are no tripping hazards and its easy for the person to move around
• Do not try to reason with the person or convince them why their belief is false
• Reassure them that everything is going to be okay
• If the person becomes aggressive, minimize your movements and remain calm
• Ask the person to talk to you about what they are feeling and really listen to them so they dont feel threatened
• If you feel like you or they are in danger, call 911

Here are a few actions you can take once the delusion has passed:

• Inform their doctor immediately
• Educate others who may care for the person how to handle the situation if it happens
• If the person is open to it, discuss it with them and ask them to explain what the experience is like for them and if theres anything different you could do next time
• Seek expert advice if you feel like you need support in managing these episodes

How Can I Help My Loved One

Your loved ones hallucination episodes are certainly disturbing, but they are usually harmless. Unlike hallucinations caused by other neurodegenerative diseases, hallucinations associated with Parkinsons disease are most often benign.

Not all hallucinations need to be treated. If they do not disrupt your loved ones daily life, there are ways to manage them well. It is still important to inform your neurologist for proper follow-up.

Talk to your loved one about their hallucinations. Together, determine what you can do when they are having a hallucination. This will help both of you be prepared and reassured when it happens.

If the hallucinations are severe, do not tell your loved one that the hallucinations are not real. This will only increase the disparity between reality and the hallucination. It may also create unnecessary conflict with your loved one who is convinced that they are hallucinating.

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Safinamide Negative Side Effects

Because of negative side effects, 3.7 percent of participants taking safinamide dropped out of clinical trials as compared with 2.4 percent of those taking a placebo.

Common adverse effects observed during these clinical trials included the following:

• jerky or fragmented motions
• falls
• nausea
• insomnia

Of these symptoms, dyskinesia was about twice as common in people taking safinamide as compared with those not taking it .

Less common but more serious adverse effects include the following:

• worsening high blood pressure
• visual hallucinations and psychotic behavior
• falling asleep during the day
• serotonin syndrome
• problems with impulse control or compulsive behavior
• fever and confusion

Here are some drugs that you shouldnt take if youre also taking safinamide:

• certain antidepressants
• cyclobenzaprine
• dextromorphan
• opioids
• St. Johns Wort

Although people with kidney impairment can take safinamide, those with severe liver problems should not take the drug.