180 Participants Needed

ACP-204 for Hallucinations

Recruiting at 17 trial locations
KK
IG
Overseen ByImran Ghiasudddin
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: ACADIA Pharmaceuticals Inc.
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called ACP-204 to determine its effectiveness in reducing hallucinations in individuals with dementia related to Lewy bodies or Parkinson's disease. Participants will receive either a low dose, a higher dose of the treatment, or a placebo (a pill with no active medicine) to compare the effects. The study spans six weeks and aims to assess both the efficacy and safety of ACP-204. Suitable candidates have been diagnosed with dementia with Lewy bodies or Parkinson’s disease with dementia and experience hallucinations. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of participants.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that ACP-204 is likely to be safe for humans?

Research has shown that ACP-204, a treatment for hallucinations, appears safe. Early studies with healthy adults found it did not affect heart function, specifically the QT interval, which measures heart rhythm. This finding is a positive sign for heart safety. Further research in animals, such as monkeys and rats, showed that ACP-204 was well tolerated, even at high doses, with no harmful effects. Although human trials are ongoing, these findings suggest that ACP-204 could be a safe option for prospective trial participants.12345

Why do researchers think this study treatment might be promising?

Most treatments for hallucinations focus on managing symptoms through medications like antipsychotics, which often come with significant side effects. But ACP-204 works differently, targeting the underlying neurological pathways that contribute to hallucinations, potentially reducing these symptoms with fewer side effects. Researchers are excited about ACP-204 because its novel mechanism of action might offer quicker relief and improved tolerability compared to current treatments. By providing a new approach, ACP-204 could significantly enhance the quality of life for those experiencing hallucinations.

What evidence suggests that ACP-204 might be an effective treatment for hallucinations?

Studies have shown that ACP-204 can reduce hallucinations and delusions in people with Alzheimer's disease. This treatment has improved overall function and quality of life. Research indicates that ACP-204 is safe, as it does not significantly affect heart rhythms, which supports its use. Although information on ACP-204 for Lewy Body Dementia Psychosis (LBDP) is limited, the positive effects observed in Alzheimer's disease suggest it might also alleviate similar symptoms in LBDP. Early findings support its potential effectiveness, but further research is needed to confirm these benefits for LBDP.12346

Are You a Good Fit for This Trial?

This trial is for men and women aged 55 to 84 with Lewy Body Dementia Psychosis, who can consent or meet specific requirements. It's not for those with serious unstable conditions, in end-of-life care, suicidal tendencies, or psychosis due to other causes.

Inclusion Criteria

I am between 55 and 84 years old.
I can sign the consent form or meet special conditions if I'm not able to.
I have been diagnosed with Parkinson's disease with dementia, dementia with Lewy bodies, or psychosis.

Exclusion Criteria

I do not have any serious or unstable health conditions.
I am in hospice, receiving end-of-life care, or bedridden.
Actively suicidal at Screening or Baseline visits
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either ACP-204 (30 mg or 60 mg) or placebo once daily for 6 weeks

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • ACP-204
Trial Overview The study tests ACP-204 against a placebo over six weeks to see if it's effective and safe for treating hallucinations in Lewy Body Dementia. Participants are randomly assigned to one of the two groups in multiple centers.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Placebo Group
Group I: ACP-204 60 mgExperimental Treatment1 Intervention
Group II: ACP-204 30 mgExperimental Treatment1 Intervention
Group III: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

ACADIA Pharmaceuticals Inc.

Lead Sponsor

Trials
49
Recruited
11,700+
Founded
1993
Headquarters
San Diego, USA
Known For
Neurological Disorders
Top Products
Nuplazid (pimavanserin), Daybue (trofinetide)

Citations

ACP-204 in Adults With Alzheimer's Disease PsychosisThe hallucinations domain score (SAPS-H) is the sum of the 7 hallucinations item scores, and the delusions domain core (SAPS-D) is the sum of the 13 delusions ...
Acadia Pharmaceuticals Initiates Phase 2 Clinical Trial of ...A Phase 2 study evaluating the efficacy and safety of ACP-204 for the treatment of hallucinations and delusions associated with Alzheimer's disease psychosis ( ...
15. DESIGN OF THE PHASE 2/3, DOUBLE-BLIND ...ACP-204-006 will be the first clinical study to evaluate the efficacy and safety of ACP-204 in patients with ADP, a population with considerable unmet needs.
Alzheimer Psychosis Agent ACP-204 Shows No Impact on ...New findings reveal ACP-204 shows no significant QT interval prolongation in healthy adults, supporting its safety for Alzheimer disease ...
Acp-204 Tartrate – Application in Therapy and Current ...Reduction in psychotic symptoms (hallucinations and delusions) Improved overall function and quality of life.
Preclinical characterization of ACP-204 reported at AAICACP-204 was well tolerated in chronic oral toxicity studies in monkeys and rats, with no adverse effects observed at the highest doses tested ( ...
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