Alzheimer's Agitation: What Families Should Know About New Studies

If you care for someone with Alzheimer's disease, you may already know the moment. A calm afternoon turns into pacing, shouting, or a refusal to let anyone near. Nothing obvious set it off, and nothing you say seems to land. This is agitation, and it is one of the most common and most exhausting parts of the disease for families.

The good news is that agitation has become a serious focus of Alzheimer's research. In the past few years, regulators have approved the first medications studied specifically for it, several new studies have reported results, and additional treatments are being evaluated in clinical trials, including one enrolling now at Arrow Clinical Trials in Daytona Beach. This guide covers what agitation is, why it happens, what the newest research says, and how families can decide whether a clinical study is worth considering.

What Agitation in Alzheimer's Actually Looks Like

Agitation is not simply "being difficult." Clinicians define it as a pattern of behaviors that are out of proportion to the situation and cause real distress or disability. The U.S. Food and Drug Administration describes it as excessive motor activity, or verbal or physical aggression, that significantly affects quality of life for both the person with Alzheimer's and the people caring for them.

In everyday terms, families tend to see some combination of the following:

• Restlessness and pacing, including walking the same route through the house, fidgeting, or an inability to sit through a meal.

• Verbal outbursts such as yelling, repeated demands, cursing, or arguing over small things.

• Resistance to care, especially during bathing, dressing, or medication time.

• Physical aggression, which can include hitting, pushing, grabbing, or throwing objects.

• Emotional distress that shows up as crying, fear, or a sense that something is terribly wrong even when nothing has changed.

Estimates vary depending on how agitation is measured and what stage of the disease is studied, but reviews consistently find that somewhere between half and three quarters of people with Alzheimer's experience clinically meaningful agitation at some point. Near the end of life, the Alzheimer's Association reports that it affects roughly half of people living with dementia.

Agitation also matters beyond the moment. Research has linked it to faster cognitive decline, higher caregiver stress, earlier placement in long-term care, and increased mortality. That is why it has moved from a footnote in Alzheimer's care to a research priority.

Agitation Is Not the Same as Psychosis

Families often hear the words agitation and psychosis used together, and the two can overlap, but they are different symptoms with different treatments and different studies.

Psychosis refers to hallucinations (seeing or hearing things that are not there) and delusions (fixed false beliefs, such as being convinced a family member is stealing). We covered this in detail in our earlier post, Understanding Alzheimer's Psychosis: What Caregivers Should Know.

Agitation is about behavior and emotional state: the restlessness, aggression, and distress described above. A person can be agitated without any hallucinations or delusions, and a person with psychosis may or may not become agitated as a result.

The distinction matters when you talk to a doctor or a research team, because studies enroll for one or the other. If you are not sure which symptoms your loved one is experiencing, write down specific examples over a week or two. That record is more useful to a clinician than a general description.

Why Agitation Happens

Agitation is a symptom, not a diagnosis, and it usually has more than one cause. The Alzheimer's Association points to a few common drivers.

Something physical is wrong and the person cannot say so. Pain, constipation, a urinary tract infection, hunger, thirst, poor sleep, or being too hot or cold are frequent hidden triggers. As Alzheimer's progresses, the ability to name a problem fades long before the ability to feel it.

The environment is overwhelming. Noise, glare, a television left on, crowds, or a change in surroundings such as travel, a hospital stay, or houseguests can overload a brain that struggles to process new information.

The routine has changed. A different caregiver, a shifted schedule, or a move can create fear and confusion that come out as agitation.

The brain itself is changing. Alzheimer's damages the circuits that regulate mood, impulse control, and the response to stress. Some agitation is driven by the disease directly, which is one reason researchers are studying medications that act on those pathways.

Because the causes stack up, most clinicians and expert panels recommend starting with non-drug approaches and a medical check for treatable problems before considering medication. The research below does not change that advice. It adds options for the people who need more.

What the Newest Research Says

The last three years have been the most active period for Alzheimer's agitation research in decades. Here is what families should know, in plain language.

The first FDA-approved medications for Alzheimer's agitation

Until 2023, no medication in the United States was approved specifically for agitation in Alzheimer's disease. Doctors prescribed antipsychotics and other drugs "off label," meaning the drugs were approved for other conditions and used based on clinical judgment. Those medications carried a boxed warning about increased risk of death in older adults with dementia-related psychosis, and the evidence that they helped with agitation was limited.

In May 2023, the FDA approved brexpiprazole (brand name Rexulti) as the first drug specifically for agitation associated with dementia due to Alzheimer's disease. It is an antipsychotic, so it carries the same boxed warning, and it was studied in two 12-week trials that showed a modest but statistically significant improvement over placebo.

On April 30, 2026, the FDA approved a second option, dextromethorphan-bupropion (brand name Auvelity), which is notable because it is the first non-antipsychotic medication approved for this use. It was tested in two studies: a five-week trial in which people taking the medication showed a greater reduction in agitation than those on placebo, and a longer "randomized withdrawal" trial in which people who had responded to the drug were switched either to continued treatment or to placebo. Those who stayed on the medication went significantly longer before their agitation returned. The most common side effects were dizziness and indigestion, and the drug carries its own warnings related to seizure risk, blood pressure, and mood changes.

For families, the takeaway is not that one of these medications is right for your loved one. It is that agitation is now recognized as a condition that deserves its own studies and its own treatments, and doctors have more than one approved option to discuss.

A cannabinoid combination for advanced dementia (the LiBBY trial)

At the Alzheimer's Association International Conference in July 2026, researchers presented results from a Phase 2 study called LiBBY, which tested an oral combination of THC and CBD in 120 hospice-eligible people with dementia and significant agitation. Over 12 weeks, the treatment group showed a meaningfully larger drop in agitation scores than the placebo group, and roughly 87 percent of treated participants improved compared with about 24 percent on placebo. Overall side-effect rates were similar between groups.

This is an early-stage result, not an approved treatment. Phase 2 studies are designed to test whether an approach works well enough to justify larger trials, and this one focused on people in the final stages of dementia. Families should not read it as a reason to try cannabis products on their own, which vary widely in dose and quality and can interact with other medications. It is, however, a sign that researchers are looking well beyond traditional psychiatric drugs.

Structured care pathways (the StaN trial)

A Canadian trial published in July 2026 in the journal Alzheimer's & Dementia tested a structured, step-by-step care pathway for agitation against usual care in 185 people in hospitals and long-term care homes. The pathway started with a "medication clean-up," moved to behavioral strategies, and only then added medications one at a time with regular measurement.

At 12 weeks, the structured pathway did not reduce agitation more than usual care, but it did reduce the number of people on multiple psychiatric medications during the early weeks. Not every study produces a breakthrough, and that is part of what makes research trustworthy. This one reinforced something clinicians already believed: fewer overlapping medications is a reasonable goal, and getting there takes a deliberate process.

New treatments in clinical trials now

Beyond the approved drugs, several investigational medications for Alzheimer's agitation are being evaluated in clinical trials across the country, including in Daytona Beach. These studies exist because the approved options do not work for everyone, have side effects some people cannot tolerate, and leave many families still searching. A clinical trial is how the next option gets tested and, if it works, becomes available to everyone.

What Families Can Do Right Now

Whether or not a study is in your future, the first steps are the same.

Rule out a medical cause. Ask your loved one's doctor to check for pain, infection, constipation, dehydration, and medication side effects. A sudden change in behavior is often a sudden change in health.

Simplify the environment. Reduce noise, turn off background television, improve lighting to cut shadows and glare, and keep the daily routine as predictable as possible.

Respond, do not argue. When agitation starts, stay calm, slow your movements, and use short reassuring phrases such as "you are safe" or "I am here." Redirect toward something familiar and pleasant: music, a walk, a photo album, a simple task. Correcting or reasoning with someone in the middle of an episode rarely helps.

Track what happens. Note the time of day, what was going on just before, and what helped. Patterns emerge, and that record is valuable to any clinician or research team you talk to.

Take care of yourself. Caregiver burnout is real and it feeds back into the person you are caring for. The Alzheimer's Association 24/7 Helpline (800-272-3900) and local support groups are there for exactly this.

Should You Consider a Clinical Study?

Families sometimes assume clinical research is a last resort or only for people who have run out of options. In practice, it is one more path to consider alongside standard care, and for agitation it has some specific advantages.

Study participants are seen frequently by a dedicated medical team, which means agitation is monitored closely rather than discussed at a routine appointment every few months. Study-related visits, medical care, and the investigational treatment are provided at no cost, and no insurance is required. Participants are typically compensated for time and travel. And every participant contributes to the evidence that decides whether a new treatment reaches other families.

Participation is always voluntary. You and your loved one can withdraw at any time, for any reason, and the study team will walk you through every step of informed consent before anything begins. We covered those protections in detail in Is a Clinical Trial Safe? Understanding Participant Protections and Informed Consent.

Alzheimer's Agitation Research in Daytona Beach

Arrow Clinical Trials is currently enrolling an Alzheimer's Agitation Study in Daytona Beach. The study is evaluating an investigational oral medication designed to help manage agitation in people living with Alzheimer's disease.

In general, the study is looking for adults age 50 and older who have been diagnosed with Alzheimer's disease and are experiencing agitation. A caregiver or study partner needs to be involved, both to attend visits and to help report on symptoms, since the person with Alzheimer's may not be able to describe changes reliably on their own.

Arrow also has several enrolling studies focused on Alzheimer's psychosis (hallucinations and delusions). If you are not sure which fits your situation, our team can help sort that out during a short phone screening.

You can learn more and complete a quick eligibility form on the study page, or call (386) 278-8000 to speak with our team.

Frequently Asked Questions

What is agitation in Alzheimer's disease?

Agitation is a pattern of restlessness, verbal or physical aggression, and emotional distress that is out of proportion to the situation and interferes with daily life. It is one of the most common behavioral symptoms of Alzheimer's and often has more than one cause, including pain, environmental overload, and changes in the brain itself.

Is there a medication approved for Alzheimer's agitation?

Yes. The FDA approved brexpiprazole (Rexulti) in 2023 and dextromethorphan-bupropion (Auvelity) in April 2026 specifically for agitation associated with Alzheimer's dementia. Both have side effects and warnings that should be discussed with a doctor, and non-drug approaches are still recommended as the first step.

What new Alzheimer's agitation studies are there in 2026?

In 2026 alone, the FDA approved a new non-antipsychotic medication, researchers presented Phase 2 results for a THC/CBD combination in advanced dementia, and a large trial of a structured care pathway was published. Additional investigational medications are being evaluated in clinical trials, including a study enrolling now in Daytona Beach.

Is agitation the same as Alzheimer's psychosis?

No. Psychosis refers to hallucinations and delusions. Agitation refers to behavior and emotional state, such as pacing, yelling, or aggression. They can occur together, but they are studied and treated separately.

Can someone with Alzheimer's agitation join a clinical trial in Daytona Beach?

Arrow Clinical Trials is enrolling an Alzheimer's Agitation Study for adults 50 and older with an Alzheimer's diagnosis and agitation symptoms. A caregiver must be involved. You can check eligibility on the study page or call (386) 278-8000.

Does the caregiver have to participate?

Yes. In agitation studies, a caregiver or study partner attends visits and helps report symptoms, because the person with Alzheimer's often cannot describe changes accurately. Caregivers are a core part of the research, not an afterthought.

What should I do first if my loved one's agitation is getting worse?

Start with a medical visit to rule out pain, infection, or medication side effects, and reduce stressors at home. If agitation continues to interfere with daily life, ask the doctor about treatment options, including whether a clinical study might be a fit.