ACP-204 in Adults With Alzheimer's Disease Psychosis

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06159673
• Other study ID #: ACP-204-006
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: November 14, 2023
• Est. completion date: February 2028

Study information

• Verified date: November 2023
• Source: ACADIA Pharmaceuticals Inc.
• Contact: Christine Murphy
• Phone: 858-465-7480
• Email: cmurphy[@]acadia-pharm.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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).

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease Psychosis
• Mental Disorders
• Psychotic Disorders

Intervention

Drug:
• ACP-204
ACP-204 is a potent and selective antagonist/inverse agonist of 5-hydroxytryptamine (serotonin) receptor subtype 2A.
• Placebo
ACP-204 matching placebo

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Gangnam-Gu	Seoul
Korea, Republic of	Inha University Hospital	Jung-gu	Incheon
Korea, Republic of	Gachon University Gil Medical Center	Namdong-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

Sponsors (1)

Lead Sponsor	Collaborator
ACADIA Pharmaceuticals Inc.

Countries where clinical trial is conducted

United States,  Korea, Republic of, 

Outcome

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