ClinicalTrials.gg
Enrolling by invitationNCT06194799Updated Nov 4, 2026

ACP-204 in Adults With Alzheimer's Disease Psychosis Open Label Extension Study

A Phase 3 interventional study of ACP-204 in Alzheimer's Disease Psychosis, sponsored by ACADIA Pharmaceuticals Inc.. Enrolling by invitation at 78 sites in 12 countries. Open to participants aged 55 Years to 95 Years. Per ClinicalTrials.gov, last updated 2026-11-04.

Sponsored by ACADIA Pharmaceuticals Inc. · Phase 3, Interventional, and Treatment

Updated Nov 4, 20262 sites addedGo to Updates ↓
Phase
Phase 3
Study type
Interventional
Enrollment
752
Allocation
Not applicable
Ages
55 Years to 95 Years
Sex
All
01

Study summary

This 52-week, open-label extension study is to evaluate the long-term safety and tolerability of ACP-204 in subjects with ADP.

02

Conditions studied

  • Alzheimer's Disease Psychosis

Keywords

  • Alzheimer's Disease Psychosis
  • Hallucinations
  • Delusions
03

In context

Hallucinations

136 studies on the registry are indexed under Hallucinations; 35 are open to participants now.

This study's planned enrollment of 752 is above the median of 48 across 118 interventional studies indexed under Hallucinations.

Browse Hallucinations studies →

Lead sponsor

ACADIA Pharmaceuticals Inc. is the lead sponsor of 41 studies on the registry; 5 are open to participants now.

Of its 26 completed or terminated interventional studies of FDA-regulated products, 24 (92%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
55 Years to 95 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Subject has successfully completed ACP-204-006 study
  • Male or female (age 55 to 95 years old): female must be of non-, male must take appropriate method if partner has childbearing potential
  • Subject has a designated study partner/caregiver
  • Subjects are able to complete all study visits with a study partner/caregiver
  • Signed inform consent form with a caregiver or legal representative

Exclusion criteria

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
  • Unstable medical condition other than AD
  • Any medical condition that in the opinion of the investigator may affect safety or ability to complete the study

Additional inclusion/exclusion criteria apply. Subjects will be evaluated at screening to ensure that all criteria for study participation are met.

Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
752 participants (estimated)

Study arms

  • Experimental
    ACP-204

    ACP-204 30mg or 60mg

    Drug: ACP-204

Interventions

  • ACP-204 30 mg given once daily, as capsule OR ACP-204 60 mg given once daily, as capsule

06

What researchers measure

Primary outcomes

  1. Treatment-emergent adverse events

    Number of Subjects With Adverse Events (AEs), Discontinuations Due to AEs and Serious AEs (SAEs) over 52 weeks of treatment. The Safety population consists of all subjects who received at least one dose of study drug in this study.

    Time frame: 52 Weeks

Secondary outcomes

  1. Clinical Global Impression-Improvement in the ADP context (CGI-I-ADP) score

    Time frame: 52 Weeks

07

Study locations

78 sites
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Sites
2 sites added
Show 2 added (2 United States)
  • Clinical Endpoints LLC · Scottsdale, United States
  • First Excellent Research · Doral, United States
Nov 4, 2026
Show all 1 update
  1. Nov 4, 2026
    2 sites added
    Show 2 added (2 United States)
    • Clinical Endpoints LLC · Scottsdale, United States
    • First Excellent Research · Doral, United States
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06194799
Responsible party
Sponsor
First posted
Jan 8, 2024
Start date
Apr 23, 2024
Primary completion
Apr 2029 (estimated)
Completion
May 2029 (estimated)
Last update
Nov 4, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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