New clinical trial targets Alzheimer’s-related psychosis

A new clinical trial at the Sharp Neurocognitive Research Center aims to help people diagnosed with Alzheimer’s disease who are experiencing symptoms of psychosis.

These symptoms can be visual or auditory, along with paranoid ideations or delusions. For example, a person may think someone called their name, but no one said anything, or they may see something or someone that is not actually there, such as people, animals or even shadows. Additionally, a person with Alzheimer’s disease experiencing paranoia or delusions may falsely believe someone is breaking into their home or that someone stole their wallet.

Approximately 30% of people with Alzheimer’s disease have symptoms of psychosis, and they are typically unaware of their condition. It is common for family members or caregivers to notice the symptoms in their loved one.

An investigative drug called ML-007C-MA may be able to treat hallucinations and delusions in Alzheimer’s patients with psychosis. The trial will determine the safety and efficacy of this medication.

How does the medication work?

The medication being tested in the trial is an oral pill. Participants will take it twice a day, twelve hours apart, meaning once in the morning and once in the evening.

The medication is meant to specifically help manage symptoms of psychosis in Alzheimer’s patients. It is not designed to improve cognition or thinking.

Who is eligible to participate in the trial?

The study is looking for a diverse group of 300 participants between the ages of 55 and 90, currently diagnosed with possible or probable Alzheimer’s. The trial is open to English and Spanish speakers.

Eligible participants must also meet the following criteria:

• Have had delusions for at least two months

• Have lived in the same residence for six weeks

• Have an active caregiver

• Cannot be in hospice or receiving end-of-life care

“It’s important we have a diverse group to participate in the study because if this treatment works, we want to make sure it works for everybody,” says Esteban Gonzalez, clinical trials specialist at Sharp Neurocognitive Research Center.

Eligible participants do not have to be Sharp patients or local residents. There are also no out-of-pocket costs to participate in the trial.

Participants will be medically evaluated by the Sharp Neurocognitive Research Center team before the trial begins to ensure they are good candidates.

What happens during the trial?

The trial is expected to last about 13 weeks with seven study visits. Participants will be monitored by Dr. Paulette Cazares, principal investigator at the Sharp Neurocognitive Research Center, along with the team members at the center.

They will also be monitored at home by their caregivers and will come to Sharp Neurocognitive Research Center for weekly assessments to see if there are any changes in their psychosis symptoms. The center can provide transportation assistance for the visits as needed.

“Having participated in more than 350 clinical trials, our team is very experienced, and we make sure participants are treated well throughout the trial,” says Gonzalez. “They are helping us drive science in the right direction.”

If you or a loved one is uncertain about eligibility or trial participation, the Sharp Neurocognitive Research Center encourages you to contact them.

“Even if you’re only slightly concerned about psychosis symptoms, call us, and we’ll assess,” Gonzalez says. “We can help someone even if they don’t qualify for the study and can point them in the right direction to address concerns.”

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