ACP-204 for Hallucinations
What You Need to Know Before You Apply
What is the purpose of this trial?
The trial aims to test a new treatment called ACP-204, a potential drug for people with Lewy Body Dementia Psychosis (LBDP) who experience hallucinations. The researchers seek to evaluate ACP-204's effectiveness over a 52-week period and determine the optimal dosage. Participants must have completed a previous related study and be able to attend all study visits with a caregiver. This trial may suit those who have experienced hallucinations due to LBDP and completed the earlier ACP-204 study. As a Phase 3 trial, it represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment for LBDP.
Do I need to stop my current medications to join the trial?
The trial information does not clearly state if you need to stop your current medications. However, if you are taking a medication that the trial protocol prohibits, you may need to stop or adjust it. It's best to discuss your specific medications with the trial team.
Is there any evidence suggesting that ACP-204 is likely to be safe for humans?
Research has shown that ACP-204 has been tested in people with Alzheimer's disease who experience psychosis. The results indicate it does not significantly affect heart rhythm, which is a positive safety sign.
Another study described ACP-204 as a medication that specifically targets certain brain receptors. It often helps manage symptoms like hallucinations and may have fewer safety concerns compared to similar medications.
Although ACP-204 is still under study and not yet FDA-approved, these studies provide early safety information. They suggest the treatment is generally well-tolerated. However, since the drug remains in development, its full safety and effectiveness are not yet known.12345Why do researchers think this study treatment might be promising?
Unlike the standard treatments for hallucinations, which often include antipsychotics like risperidone or olanzapine, ACP-204 offers a novel approach by potentially targeting specific pathways in the brain with its active ingredient. This experimental drug is unique because it allows flexible dosing, starting at 30 mg and going up to 60 mg if needed, which could help fine-tune treatment to individual needs. Researchers are excited about its potential to provide more effective symptom control while minimizing side effects, offering a promising alternative to current options.
What evidence suggests that ACP-204 might be an effective treatment for Lewy Body Dementia Psychosis?
Research shows that ACP-204 is under investigation in this trial to determine its effectiveness in addressing hallucinations and delusions in individuals with Alzheimer's disease psychosis. In earlier studies, participants with Alzheimer's disease showed some improvement in hallucination symptoms when taking ACP-204. Although data for Lewy Body Dementia Psychosis is not yet available, testing ACP-204 for similar symptoms in Alzheimer's suggests potential effectiveness. Importantly, ACP-204 has not caused major heart-related side effects, indicating a positive safety profile. Overall, researchers are closely monitoring the treatment's ability to manage psychosis symptoms.13467
Are You a Good Fit for This Trial?
This trial is for adults with Lewy Body Dementia Psychosis who completed the prior ACP-204-012 study without early discontinuation. Participants must be able to attend all visits with a caregiver and give consent. Women must not be able to bear children, and men agree to contraception.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Open-label Extension
Participants receive ACP-204 with dose adjustments allowed based on efficacy
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- ACP-204
Trial Overview
The trial tests long-term use of ACP-204 in treating hallucinations associated with Lewy Body Dementia over 52 weeks. It's an open-label extension, meaning everyone knows they're getting the actual drug, not a placebo.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Initiation of treatment with ACP-204 at a dose of 30 mg once daily. During the trial, the dose may be adjusted, i.e. uptitration to 60 mg in case of suboptimal efficacy or subsequent down titration to 30 mg. Repeated titration steps are allowed.
Find a Clinic Near You
Who Is Running the Clinical Trial?
ACADIA Pharmaceuticals Inc.
Lead Sponsor
Citations
ACP-204 in Adults With Alzheimer's Disease Psychosis
The 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 ...
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.
3.
acadia.com
acadia.com/en-us/media/news-releases/acadia-pharmaceuticals-initiates-phase-2-clinical-trial-acp-204Acadia 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 ( ...
4.
neurologylive.com
neurologylive.com/view/alzheimer-psychosis-agent-acp-204-shows-no-impact-corrected-qt-intervals-in-phase-1-analysisAlzheimer 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 ...
5.
synapse.patsnap.com
synapse.patsnap.com/blog/acadia-pharmaceuticals-starts-the-phase-2-study-of-acp-204-in-treating-alzheimers-disease-related-psychosisAcadia Pharmaceuticals starts the Phase 2 study of ACP ...
Acadia Pharmaceuticals Inc. has declared the commencement of a Phase 2 trial to assess the effectiveness and safety of ACP-204 in treating hallucinations and ...
acp-204-clinical-development-program-in-lewy-body- ...
ACP-204 is an investigational agent, and its safety and efficacy have not been established and approved by the FDA. This letter is not intended to promote or ...
ACP-204 in Adults With Alzheimer's Disease Psychosis
The 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 ...
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