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RecruitingPHASE2INTERVENTIONAL

Phase 2, Efficacy and Safety Study of ACP-204 in Lewy Body Dementia Psychosis

This research study is looking at a new medication called ACP-204 for people living with Lewy body dementia who are also experiencing psychosis. Psychosis means seeing or hearing things that aren't real, or having strong untrue beliefs. The main goal is to find out if ACP-204 is safe to use and if it can help reduce these distressing symptoms. Participants will be randomly assigned to receive either the new drug or a placebo (a dummy pill with no active medicine), and neither they nor their doctors will know which they are getting. This study is expected to last for about 6 weeks and involves people aged 55 to 84. It's a way to explore new treatments that could improve life for those affected by Lewy body dementia and psychosis.

At a glance

Status
Recruiting
Phase
PHASE2
Sponsor
ACADIA Pharmaceuticals Inc.
Enrolment target
180
Start
06 Aug 2025
Estimated completion
01 Mar 2028

What is this study about?

This study is investigating a new treatment called ACP-204 for a specific group of people: those diagnosed with Lewy body dementia who are also experiencing psychosis. Lewy body dementia is a type of dementia that can cause problems with thinking, movement, and sleep, and often leads to episodes of psychosis, such as hallucinations (seeing things that aren't there) or delusions (strong, untrue beliefs).

The main purpose of this study is to see if ACP-204 is an effective and safe medication to help reduce these psychotic symptoms. By giving some people the active drug and others a placebo (a dummy pill without active medicine), the researchers can compare the results and understand if ACP-204 makes a difference. This type of study, where neither the patient nor their doctor knows who is getting the active drug, helps ensure the results are as fair and unbiased as possible.

Finding new ways to manage psychosis in Lewy body dementia is very important, as these symptoms can be very distressing for patients and their families. This study is a step towards potentially developing better treatments to improve the quality of life for people living with this challenging condition.

Key takeaways

  • This study is testing a new drug (ACP-204) for psychosis in Lewy body dementia.
  • It aims to find out if the drug is safe and effective.
  • Participants will receive either the new drug or a dummy pill (placebo).
  • The study lasts about 6 weeks and involves regular clinic visits.
  • Patients aged 55-84 with specific dementia and psychosis diagnoses are eligible.
  • Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To join this study, you need to be between 55 and 84 years old. You must have a clear diagnosis of either Parkinson's disease with dementia or probable dementia with Lewy bodies. Additionally, you need to be experiencing psychosis related to your dementia.

There are also some reasons why you might not be able to join. For example, if your psychotic symptoms are primarily due to something else, like delirium, substance use, or a different mental health condition, this study might not be right for you. If you have serious or unstable health conditions affecting your heart, lungs, kidneys, liver, or other major body systems, or if you've recently had a stroke or significant head injury, you would likely not be able to take part.

Finally, if you are currently receiving hospice care, are bedridden, or have conditions that would make it difficult to follow the study procedures, you wouldn't be eligible. It's important that your general health is stable enough to safely participate.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you between 55 and 84 years old?
  2. Do you have a diagnosis of Lewy body dementia or Parkinson's disease with dementia?
  3. Are you currently experiencing psychosis related to your dementia?
  4. Do you have any serious, unstable medical conditions?
  5. Are you currently receiving hospice care or end-of-life palliative care?
  6. Are your psychotic symptoms mainly caused by substance use or another condition (not dementia)?
Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be involved in this study for about 6 weeks. Before starting, there will be a 'screening visit' to check if you meet all the requirements. If you do, you'll then have a 'baseline visit' where various assessments will be done.

Throughout the study, you'll be given either the new study drug, ACP-204, or an inactive dummy pill (placebo). Neither you nor your study doctor will know which one you are receiving. You will have regular visits to the study clinic where the research team will monitor your health, check for any changes in your symptoms, and assess how well you are coping. These visits will likely include physical examinations, blood tests, and questionnaires to track your symptoms and overall well-being. It's important to attend all scheduled visits and follow the study instructions carefully. After the 6-week treatment period, there will be a final follow-up to ensure your safety.

Potential risks and benefits

Taking part in any clinical trial involves both potential benefits and risks. A potential benefit of joining this study is that the investigational drug, ACP-204, might help reduce the symptoms of psychosis you are experiencing. However, there's no guarantee it will work for everyone, or even work at all, and you might receive the placebo instead of the active drug. Potential risks could include side effects from the medication, which will be carefully monitored by the study team. You will be told about all known possible side effects before you decide to join. It is very important to remember that participating in this study is entirely voluntary, and you are free to withdraw at any time for any reason without it affecting your usual medical care.

Locations (56)

  • ATP Clinical Research Inc.
    Verified postcode
    Irvine, United States· Recruiting
  • Georgetown University
    Verified postcode
    Washington D.C., United States· Recruiting
  • Humanity Clinical Research, Corp
    Verified postcode
    Aventura, United States· Recruiting
  • Parkinson's Disease and Movement Disorders Center of Boca Raton
    Verified postcode
    Boca Raton, United States· Recruiting
  • K2 Medical Research Winter Garden LLC
    Verified postcode
    Clermont, United States· Recruiting
  • University of Florida - Shands
    Verified postcode
    Gainesville, United States· Recruiting
  • K2 Summit Research
    Verified postcode
    Lady Lake, United States· Recruiting
  • Neurology Associates, P. A.
    Verified postcode
    Maitland, United States· Recruiting
  • Homestead Associates in Research Inc
    Verified postcode
    Miami, United States· Recruiting
  • Premier Clinical Research Institute, Inc.
    Verified postcode
    Miami, United States· Recruiting
  • Advanced Clinical Research Network, Corp
    Verified postcode
    Miami, United States· Recruiting
  • MediClear Medical & Research Center, Inc.
    Verified postcode
    Miami, United States· Recruiting

Common questions

What is psychosis?

Psychosis means experiencing things that aren't real, like seeing or hearing things others don't (hallucinations), or believing things that aren't true (delusions).

What is Lewy body dementia?

Lewy body dementia is a type of dementia that affects thinking, movement, and often causes hallucinations and fluctuating alertness.

What is a 'placebo'?

A placebo is a 'dummy' pill or treatment that looks like the study drug but contains no active medicine. It helps researchers see if the real drug is effective.

How long does the study last?

The main treatment part of this study is expected to last for about 6 weeks.

Who is funding this study?

Details about funding are usually found on the study's official website or patient information sheet, which you can ask your doctor for.

How to find out more

Kristin Kidd

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "Phase 2, Efficacy and Safety Study of ACP-204 in Lewy Body D…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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