ACP-204 in Adults With Alzheimer's Disease Psychosis

Conditions

• Alzheimer's Disease Psychosis

Eligibility Criteria

Sex

ALL

Age

55 Years - 95 Years

Healthy Volunteers

Not accepted

Interventions

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

Study Details

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).

Key Dates

Start date

Nov 14, 2023

Status verified

Jan 2026

Primary completion

Jan 31, 2028

Completion

Feb 29, 2028

Study Design

Enrollment

1,074 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: ACP-204 30 mg
  Administration once daily at approximately the same time of day, with or without food
• Experimental: ACP-204 60 mg
  Administration once daily at approximately the same time of day, with or without food
• Placebo Comparator: Placebo
  Administration once daily at approximately the same time of day, with or without food

Primary Outcome Measure

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 ]

Central Contacts

• Christine Murphy
  858-465-7480
  [email protected]
• Kristen White
  813-838-6468
  [email protected]

Locations (45)

Find similar trials in Chandler, AZ

Related Studies

• ACP-204 in Adults With Alzheimer's Disease Psychosis Open Label Extension Study
  PHASE3 · Enrolling By Invitation · ACADIA Pharmaceuticals Inc. · Costa Mesa, California