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

Acadia Pharmaceuticals logo

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)

752 participants in 1 patient group

ACP-204
Experimental group
Description:
ACP-204 30mg or 60mg
Treatment:
Drug: ACP-204

Trial contacts and locations

7

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Central trial contact

Christine Murphy; Camil Castelo-Branco, MD PhD

Data sourced from clinicaltrials.gov

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