Alzheimer's Disease Psychosis Clinical Trial
Official title:
A Master Protocol for Three Independent, Seamlessly Enrolling, Double-blind, Placebo-controlled Efficacy and Safety Studies of ACP-204 in Adults With Alzheimer's Disease Psychosis
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 42 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).
| Status | Recruiting |
| Enrollment | 1074 |
| Est. completion date | February 2028 |
| Est. primary completion date | January 2028 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 55 Years to 95 Years |
| Eligibility | Inclusion Criteria: - Is male or female and =55 and =95 years of age living in the community or in an institutionalized setting - Meets clinical criteria for possible or probable AD based on the 2011 National Institute on Aging-Alzheimer Association (NIA-AA) criteria - Meets the revised criteria for psychosis in major or mild neurocognitive disorder established by the International Psychogeriatrics Association (IPA) - Has either blood-based biomarker or documented evidence (e.g. positron emission tomography, cerebrospinal fluid biomarker) indicating amyloid plaque deposition and neuropathologic change consistent with AD - Has a prior magnetic resonance imaging or computed tomography scan of the brain that is consistent with the diagnosis of AD - Meets revised criteria for psychosis in major or mild neurocognitive disorder as per International Psychogeriatrics Association - MMSE score =6 and =24 - Psychotic symptoms for at least 2 months - Lives in a stable place of residence and there are no plans to change living arrangements - Has a designated study partner/caregiver - Able to complete all study visits with a study partner/caregiver - Must be on a stable dose of cholinesterase inhibitor or memantine, if applicable Exclusion Criteria: - Requires treatment with a medication prohibited by the protocol - Is in hospice and receiving end-of-life palliative care, or has become bedridden - Requires skilled nursing care - Psychotic symptoms that are primarily attributable to delirium, substance abuse, or a medical or psychiatric condition other than dementia - Known history of cerebral amyloid angiopathy, epilepsy, central nervous system neoplasm, or unexplained syncope - Atrial fibrillation - Symptomatic orthostatic hypotension - Protocol-defined exclusionary clinical laboratory findings Additional inclusion/exclusion criteria apply. Subjects will be evaluated at screening to ensure that all criteria for study participation are met. |
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | Samsung Medical Center | Gangnam-Gu | Seoul |
| Korea, Republic of | Inha University Hospital | Jung-gu | Incheon |
| United States | Abington Neurological Associates | Abington | Pennsylvania |
| United States | Dent Neurologic Institute | Amherst | New York |
| United States | Advanced Research Center, Inc. | Anaheim | California |
| United States | Insight Clinical Trials LLC | Beachwood | Ohio |
| United States | Regional Neurological Associates | Bronx | New York |
| United States | Valley Medical Research | Centerville | Ohio |
| United States | ATP Clinical Research | Costa Mesa | California |
| United States | Arrow Clinical Trials | Daytona Beach | Florida |
| United States | Revive Research Institute, Inc. | Elgin | Illinois |
| United States | Neuro-Pain Medical Center | Fresno | California |
| United States | National Institute of Clinical Research | Garden Grove | California |
| United States | New Life Medical Research Center Inc. | Hialeah | Florida |
| United States | Reliable Clinical Research LLC. | Hialeah | Florida |
| United States | Clinical Trial Network LLC | Houston | Texas |
| United States | Kaleidoscope Clinical Research | Houston | Texas |
| United States | University of Texas Health Science Center | Houston | Texas |
| United States | Alivation Research, LLC | Lincoln | Nebraska |
| United States | Advanced Clinical Research Network, Corp | Miami | Florida |
| United States | Future Care Solution, LLC | Miami | Florida |
| United States | Homestead Associates in Research Inc. | Miami | Florida |
| United States | MediClear Medical & Research Center, Inc. | Miami | Florida |
| United States | Premier Clinical Research Institute, Inc. | Miami | Florida |
| United States | Verus Clinical Research | Miami | Florida |
| United States | Visionary Investigators Network | Miami | Florida |
| United States | Quantum Clinical Trials | Miami Beach | Florida |
| United States | Floridian Neuroscience Institutue | Miami Lakes | Florida |
| United States | Finger Lakes Clinical Research | Rochester | New York |
| United States | Khan Revive Research Institute | Rochester Hills | Michigan |
| United States | R & H Clinical Research Inc. | Stafford | Texas |
| United States | Neuroscience Research Institute | West Palm Beach | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| ACADIA Pharmaceuticals Inc. |
United States, Korea, Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Scale for the Assessment of Positive Symptoms-Hallucinations and Delusions subscales (SAPS-H+D) total score change from baseline (Substudies 1, 2A, 2B) | 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. | From baseline to Week 6 | |
| Secondary | Clinical Global Impression-Improvement in the ADP context (CGI-I-ADP) score | The CGI-I scale is a clinician-rated, 7-point scale used to rate the improvement in symptoms at the time of assessment, relative to the symptoms at Baseline. The CGI-I-ADP scale is the CGI-I scale applied in the ADP context, in which hallucinations and delusions are the symptoms of interest. | Week 6 |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
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Phase 2 | |
| Enrolling by invitation |
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ACP-204 in Adults With Alzheimer's Disease Psychosis Open Label Extension Study
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Phase 3 |