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ACP-204 for Alzheimer's Disease

Phase 2 & 3
Recruiting
Research Sponsored by ACADIA Pharmaceuticals Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Has a prior magnetic resonance imaging or computed tomography scan of the brain that is consistent with the diagnosis of AD
On a stable dose of medication?
Timeline
Screening 42 days
Treatment 6 weeks
Follow Up 30 days

Summary

This trial tests a drug for Alzheimer's Disease Prodromal (ADP) in 3 parts, evaluating safety, efficacy, and dose response.

Who is the study for?
This trial is for adults aged 55 to 95 with Alzheimer's Disease Psychosis (ADP), living at home or in a facility, who have a caregiver and are stable on certain dementia medications. They must meet specific criteria for ADP diagnosis, including evidence of amyloid plaque deposition. Excluded are those needing prohibited meds, receiving end-of-life care, having conditions that explain their psychosis other than dementia, or with certain medical exclusions like atrial fibrillation.
What is being tested?
The study tests ACP-204 at two doses (30 mg and 60 mg) against a placebo in three parts: an initial phase to assess efficacy and dose response followed by two confirmatory phases for the chosen doses. Each participant undergoes screening, six weeks of treatment, safety follow-up unless entering an extension study, and vital status updates if leaving early.
What are the potential side effects?
While the side effects aren't specified here, typical clinical trials may monitor for reactions related to mental state changes such as agitation or confusion; physical symptoms like dizziness or headaches; gastrointestinal issues; sleep disturbances; and potential allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 42 days
Treatment ~ 6 weeks
Follow Up ~30 days
This trial's timeline: 42 days for screening, 6 weeks for treatment, and 30 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Scale for the Assessment of Positive Symptoms-Hallucinations and Delusions subscales (SAPS-H+D) total score change from baseline (Substudies 1, 2A, 2B)
Secondary study objectives
Clinical Global Impression-Improvement in the ADP context (CGI-I-ADP) score

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: ACP-204 60 mgExperimental Treatment1 Intervention
Administration once daily at approximately the same time of day, with or without food
Group II: ACP-204 30 mgExperimental Treatment1 Intervention
Administration once daily at approximately the same time of day, with or without food
Group III: PlaceboPlacebo Group1 Intervention
Administration once daily at approximately the same time of day, with or without food

Find a Location

Logistics

Travel, including flights, are covered

Your expenses for travel tickets for this trial will be reimbursed.

Other reimbursement is provided

Other forms of reimbursement are provided for this trial.

Who is running the clinical trial?

ACADIA Pharmaceuticals Inc.Lead Sponsor
47 Previous Clinical Trials
10,521 Total Patients Enrolled
~716 spots leftby Jan 2028
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