← Trials/Trial dossier/NCT06194799

Enrolling by invitationPhase 3

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

A 52-Week, Open-Label Extension Study of ACP-204 in Adults With Alzheimer's Disease Psychosis

Lead sponsor

ACADIA Pharmaceuticals Inc.

Asset

ACP-204

Listed sites

Recruiting sites

Enrollment

752

estimated

Study population

Alzheimer’s disease

Key I/E criterion

•Study partner/caregiver required

Primary endpoint

•Treatment-emergent adverse events

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDACP-204-008

Secondary IDLuminousAcadia Pharmacueticals

NCT IDNCT06194799

Timeline

Milestones

Study first posted2024-01-08actual

Study start2024-04-23actual

Last update posted2026-07-02actual

Primary completion2029-04estimated (month precision)

Study completion2029-05estimated (month precision)

Assets

Drug assets

ACP-204

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age55 Years

Maximum age95 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Subject has successfully completed ACP-204-006 study

•Male or female (age 55 to 95 years old): female must be of non-childbearing potential, male must take appropriate contraceptive 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

•Requires treatment with a medication prohibited by the protocol

•Is in hospice and receiving end-of-life palliative care, or has become bedridden

•Unstable clinically significant 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.

Endpoints (2)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Safety / tolerability / PK

Other clinical outcomes

Safety / tolerability / PK

1 endpoint

Primary/protocol endpoint

Treatment-emergent adverse events

Time frame:52 Weeks

event count, event

Other clinical outcomes

1 endpoint

Secondary/protocol endpoint

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

Time frame:52 Weeks

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.