ACP-204 for Alzheimer's Disease Psychosis

ACP-204 in Adults With Alzheimer's Disease Psychosis

Recruiting Phase 2 Phase 3 Interventional Study
Alzheimer's Disease Psychosis
Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
55 – 95
Sex
Any
Trial phase
Phase 2/3
Study type
Interventional
Purpose
Treatment
Participants needed
1,074 (estimated)
Sponsor
ACADIA Pharmaceuticals Inc. · Industry
Who this trial is looking for

This trial is looking for adults aged 55 to 95 who have Alzheimer's disease psychosis. Participants will receive either ACP-204 or a placebo for six weeks, with follow-up visits to check on their health afterwards.

Are You a Good Fit for This Trial?
Must be taking Cholinesterase inhibitorMemantine

You may be able to join if

  • I am aged 55 to 95 years.
  • I have been diagnosed with Alzheimer's disease.
  • I have psychotic symptoms for at least 2 months.
  • I live in a stable place and won't change my living arrangements.
  • I have a designated study partner or caregiver.
  • I can complete all study visits with my study partner or caregiver.
  • I am on a stable dose of cholinesterase inhibitor or memantine, if applicable.

You may not be able to join if

  • I am receiving end-of-life palliative care or am bedridden.
  • I require skilled nursing care.
  • My psychotic symptoms are due to delirium, substance abuse, or another medical condition.
  • I have a history of cerebral amyloid angiopathy, epilepsy, or unexplained fainting.
  • I have atrial fibrillation.
  • I have symptomatic orthostatic hypotension.
  • I have had treatment with anti-tau therapy or donanemab in the last 2 months.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

Think this trial could be right for you?

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About This Trial
This is a master protocol for 3 independent, seamlessly enrolling, multicenter, randomized, double-blind, placebo-controlled, parallel-group studies in patients with ADP * Substudy 1 (Phase 2) will evaluate efficacy and dose response of ACP-204 30 and 60 mg vs placebo. This substudy will be initiated first. * Substudies 2A and 2B (both: Phase 3) will be confirmatory studies of either both doses (…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Is male or female and ≥55 and ≤95 years of age living in the community or in an institutionalized setting * Meets clinical criteria for possible or probable AD based on the 2011 National Institute on Aging-Alzheimer Association (NIA-AA) criteria * Meets the revised criteria fo…
Contacts

Christine Murphy

858-465-7480

cmurphy@acadia-pharm.com

CONTACT

Kristen White

813-838-6468

kristen.white@acadia-pharm.com

CONTACT