History of Changes for Study: NCT06159673

ACP-204 in Adults With Alzheimer's Disease Psychosis

A study version is represented by a row in the table.
Select two study versions to compare. One each from columns A and B.
Choose either the "Merged" or "Side-by-Side" comparison format to specify how the two study versions are to be displayed. The Side-by-Side format only applies to the Protocol section of the study.
Click "Compare" to do the comparison and show the differences.
Select a version's Submitted Date link to see a rendering of the study for that version.
The yellow A/B choices in the table indicate the study versions currently compared below. A yellow table row indicates the study version currently being viewed.
Hover over the "Recruitment Status" to see how the study's recruitment status changed.
Study edits or deletions are displayed in red.
Study additions are displayed in green.

Study Record Versions

Version	Submitted Date	Changes
1	November 27, 2023	None (earliest Version on record)
2	December 11, 2023	Contacts/Locations and Study Status
3	January 19, 2024	Contacts/Locations and Study Status
4	January 26, 2024	Contacts/Locations and Study Status
5	February 9, 2024	Contacts/Locations and Study Status
6	February 20, 2024	Contacts/Locations and Study Status
7	March 1, 2024	Contacts/Locations and Study Status
8	March 15, 2024	Contacts/Locations and Study Status
9	March 22, 2024	Contacts/Locations and Study Status
10	April 1, 2024	Contacts/Locations and Study Status
11	April 5, 2024	Contacts/Locations and Study Status
12	April 15, 2024	Contacts/Locations and Study Status
13	April 26, 2024	Contacts/Locations and Study Status
14	May 6, 2024	Contacts/Locations and Study Status

Comparison Format:

Merged
Side-by-Side

Study Identification


Unique Protocol ID:	ACP-204-006
Brief Title:	ACP-204 in Adults With Alzheimer's Disease Psychosis
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
Secondary IDs:

Study Status


Record Verification:	November 2023
Overall Status:	Recruiting
Study Start:	November 14, 2023
Primary Completion:	January 2028 [Anticipated]
Study Completion:	February 2028 [Anticipated]

First Submitted:	November 27, 2023
First Submitted that Met QC Criteria:	November 27, 2023
First Posted:	December 7, 2023 [Actual]

Last Update Submitted that Met QC Criteria:	November 27, 2023
Last Update Posted:	December 7, 2023 [Actual]

Sponsor/Collaborators


Sponsor:	ACADIA Pharmaceuticals Inc.
Responsible Party:	Sponsor
Collaborators:

Oversight


U.S. FDA-regulated Drug:	Yes
U.S. FDA-regulated Device:	No
Data Monitoring:	Yes

Study Description

Brief 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).

Detailed Description:

Conditions


Conditions:	Alzheimer's Disease Psychosis
Keywords:	Alzheimer's disease psychosis Hallucinations Delusions

Study Design


Study Type:	Interventional
Primary Purpose:	Treatment
Study Phase:	Phase 2/Phase 3
Interventional Study Model:	Parallel Assignment
Number of Arms:	3
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:	Randomized
Enrollment:	1074 [Anticipated]

Arms and Interventions

Arms	Assigned Interventions
Experimental: ACP-204 30 mg Administration once daily at approximately the same time of day, with or without food	Drug: ACP-204 ACP-204 is a potent and selective antagonist/inverse agonist of 5-hydroxytryptamine (serotonin) receptor subtype 2A.
Experimental: ACP-204 60 mg Administration once daily at approximately the same time of day, with or without food	Drug: ACP-204 ACP-204 is a potent and selective antagonist/inverse agonist of 5-hydroxytryptamine (serotonin) receptor subtype 2A.
Placebo Comparator: Placebo Administration once daily at approximately the same time of day, with or without food	Drug: Placebo ACP-204 matching placebo

Outcome Measures


Primary Outcome Measures:
1.	Scale for the Assessment of Positive Symptoms-Hallucinations and Delusions subscales (SAPS-H+D) total score change from baseline (Substudies 1, 2A, 2B) [ Time Frame: 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.
Secondary Outcome Measures:
1.	Clinical Global Impression-Improvement in the ADP context (CGI-I-ADP) score [ Time Frame: Week 6 ] 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.

Eligibility


Minimum Age:	55 Years
Maximum Age:	95 Years
Sex:	All
Gender Based:
Accepts Healthy Volunteers:	No
Criteria:	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.

Contacts/Locations


Central Contact Person:	Christine Murphy Telephone: 858-465-7480 Email: cmurphy@acadia-pharm.com
Central Contact Backup:	Mariana Alvarado Telephone: 415-265-0796 Email: mariana.alvarado@acadia-pharm.com
Locations:	United States, Florida
	MediClear Medical & Research Center, Inc. [Recruiting] Miami, Florida, United States, 33165

IPDSharing


Plan to Share IPD:	No

References


Citations:
Links:
Available IPD/Information: