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

Acadia Pharmaceuticals

Status and phase: Invitation-only; Phase 3

Conditions: Alzheimer's Disease Psychosis

Treatments: Drug: ACP-204

Study type: Interventional

Funder types: Industry

Identifiers

NCT06194799

Luminous (Other Identifier)

ACP-204-008

Details and patient eligibility

About

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

Enrollment: 752 estimated patients

Sex: All

Ages: 55 to 95 years old

Volunteers: No Healthy Volunteers

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
• Female who is pregnant or breastfeeding
• 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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752 participants in 1 patient group

ACP-204

Experimental group

Description:

ACP-204 30mg or 60mg

Treatment:

Drug: ACP-204