ACP-204 in Adults With Alzheimer's Disease Psychosis
Condition(s) studied
Investigational drug(s) / intervention(s)
ACP-204: ACP-204 is a potent and selective antagonist/inverse agonist of 5-hydroxytryptamine (serotonin) receptor subtype 2A.
Placebo: ACP-204 matching placebo
Study summary
This is a master protocol for 3 independent, seamlessly enrolling, multicenter, randomized, double-blind, placebo-controlled, parallel-group studies in patients with ADP
* Substudy 1 (Phase 2) will evaluate efficacy and dose response of ACP-204 30 and 60 mg vs placebo. This substudy will be initiated first.
* Substudies 2A and 2B (both: Phase 3) will be confirmatory studies of either both doses (ACP-204 30 and 60 mg, respectively) or a single dose from Part 1 vs placebo. Substudies 2A and 2B will be performed independently of each other and will commence after enrollment of Part 1.
All 3 substudies will be analyzed independently of each other.
Each substudy individually will consist of a screening period (up to 49 days); a double-blind treatment period (6 weeks); a safety follow-up period (30 days) for patients not rolling over into an open-label extension study; and vital status follow-up (for patients who terminated their substudy early).
Eligibility
Primary outcome measure(s)
- Scale for the Assessment of Positive Symptoms-Hallucinations and Delusions subscales (SAPS-H+D) total score change from baseline (Substudies 1, 2A, 2B) — From baseline to Week 6
The SAPS-H+D subscales are a measure of two psychotic symptoms: hallucinations and delusions. The SAPS-H+D total score is the sum of the scores of the Hallucinations and Delusions subscales. 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 item scores.
Trial sites (152)
| Facility | City | Region | Status |
|---|---|---|---|
| Chandler Clinical Trials | Chandler | Arizona | Recruiting |
| Clinical Endpoint LLC | Scottsdale | Arizona | Recruiting |
| Advanced Research Center, Inc. | Anaheim | California | Withdrawn |
| ATP Clinical Research | Costa Mesa | California | Recruiting |
| Neuro-Pain Medical Center | Fresno | California | Recruiting |
| National Institute of Clinical Research | Garden Grove | California | Terminated |
| Havana Research Institute LLC | Pasadena | California | Recruiting |
| Humanity Clinical Research Corp | Aventura | Florida | Recruiting |
| Arrow Clinical Trials | Daytona Beach | Florida | Recruiting |
| First Excellent Research Group | Doral | Florida | Recruiting |
| New Life Medical Research Center Inc. | Hialeah | Florida | Recruiting |
| Reliable Clinical Research LLC. | Hialeah | Florida | Recruiting |
| Homestead Associates in Research Inc. | Miami | Florida | Recruiting |
| Premier Clinical Research Institute, Inc. | Miami | Florida | Recruiting |
| Central Miami Medical Institute | Miami | Florida | Withdrawn |
| Advanced Clinical Research Network, Corp | Miami | Florida | Recruiting |
| Verus Clinical Research | Miami | Florida | Recruiting |
| Future Care Solution, LLC | Miami | Florida | Recruiting |
| MediClear Medical & Research Center, Inc. | Miami | Florida | Recruiting |
| ABBA Medical Group LLC | Miami | Florida | Recruiting |
| Visionary Investigators Network | Miami | Florida | Withdrawn |
| Quantum Clinical Trials | Miami Beach | Florida | Recruiting |
| New Med Research | Miami Gardens | Florida | Recruiting |
| Floridian Neuroscience Institutue | Miami Lakes | Florida | Recruiting |
| Combined Research Orlando Phase I IV | Orlando | Florida | Recruiting |
| Psych Me Medical Research Inc | Tampa | Florida | Withdrawn |
| Neuroscience Research Institute | West Palm Beach | Florida | Recruiting |
| Revive Research Institute, Inc. | Elgin | Illinois | Withdrawn |
| Grace Research, LLC | Shreveport | Louisiana | Recruiting |
| CBH Health LLC, dba CenExcel Gaitherburg | Gaithersburg | Maryland | Recruiting |
| Khan Revive Research Institute | Rochester Hills | Michigan | Withdrawn |
| Tekton Research, LLC | St Louis | Missouri | Recruiting |
| Alivation Research, LLC | Lincoln | Nebraska | Withdrawn |
| Dent Neurologic Institute | Amherst | New York | Withdrawn |
| Finger Lakes Clinical Research | Rochester | New York | Withdrawn |
| SUNY Upstate Medical University | Syracuse | New York | Recruiting |
| Regional Neurological Associates | The Bronx | New York | Withdrawn |
| Insight Clinical Trials LLC | Beachwood | Ohio | Withdrawn |
| Valley Medical Research | Centerville | Ohio | Withdrawn |
| NDx Clinical Research Inc. | Dayton | Ohio | Recruiting |
+ 112 more sites — see the full list on the official registry below.
More ACADIA Pharmaceuticals Inc. trials in Italy
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06159673 on ClinicalTrials.gov ↗ ← All trials in Italy