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ACP-204 for Alzheimer's Disease

Phase 3
Waitlist Available
Research Sponsored by ACADIA Pharmaceuticals Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Be older than 18 years old
Must not have
Female who is pregnant or breastfeeding
Unstable clinically significant medical condition other than AD
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 52 weeks
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial is a 52-week study that aims to assess the safety and tolerability of ACP-204 in individuals with ADP over a longer period of time.

Who is the study for?
This trial is for adults aged 55 to 95 with Alzheimer's Disease Psychosis who finished the ACP-204-006 study. Participants need a caregiver, must not be pregnant or breastfeeding, and should not have any severe medical conditions that could affect their safety or ability to complete the study.
What is being tested?
The trial is testing the long-term safety and effectiveness of a drug called ACP-204 over a period of one year in patients with Alzheimer's Disease Psychosis who have already completed an initial study.
What are the potential side effects?
While specific side effects are not listed here, participants will be monitored for any adverse reactions to ACP-204 throughout this extension phase to assess its long-term tolerability.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 55 and 95 years old. If female, I cannot have children. If male, I will use contraception.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not pregnant or breastfeeding.
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I do not have any unstable health conditions besides Alzheimer's Disease.
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I need to take a medication that is not allowed in this study.
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I am in hospice care or unable to leave my bed.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~52 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 52 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Treatment-emergent adverse events

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups
Experimental Treatment
Group I: ACP-204Experimental Treatment1 Intervention
ACP-204 30mg or 60mg

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Who is running the clinical trial?

ACADIA Pharmaceuticals Inc.Lead Sponsor
47 Previous Clinical Trials
10,852 Total Patients Enrolled
~501 spots leftby Apr 2029
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