Phase 3 Alzheimer's Disease Trial, Recruiting NCT06159673 Sponsor: ACADIA Pharmaceuticals Inc. Condition: Alzheimer's Disease
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Phase 3 Alzheimer's Disease Trial, Recruiting

NCT06159673
Recruiting Phase 3

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People aged 55 to 95 who live either in their own home in the community or in a care facility such as a nursing home or assisted living
  • People who have been diagnosed with possible or probable Alzheimer's disease based on recognised medical guidelines (the 2011 NIA-AA criteria)
  • People who have psychosis symptoms linked to a major or mild thinking and memory disorder, as defined by international guidelines (IPA criteria)
  • People who have evidence of Alzheimer's-related changes in the brain, shown through a blood test, a brain scan (such as a PET scan), or fluid taken from around the spine
  • People who have had a brain scan (MRI or CT) whose results are in line with an Alzheimer's disease diagnosis
  • People whose score on a standard memory and thinking test (called the MMSE) falls between 6 and 24
  • People who have been experiencing psychosis symptoms (such as hallucinations or unusual beliefs) for at least 2 months
  • People who have a stable living situation with no planned changes to where they live
  • People who have a designated caregiver or support person able to assist throughout the study
  • People who are taking a stable dose of certain Alzheimer's medications (such as a cholinesterase inhibitor or memantine), if those medications have been prescribed

Who may not be able to join:

  • People who need to take a medication that is not permitted under the trial's rules
  • People who are in hospice or end-of-life palliative care, or who are no longer able to get out of bed
  • People who require skilled nursing care
  • People whose psychosis symptoms are mainly caused by delirium, substance use, or a medical or mental health condition other than dementia
  • People with a known history of a brain blood vessel condition called cerebral amyloid angiopathy, epilepsy, a brain tumour, or unexplained episodes of fainting
  • People with atrial fibrillation (an irregular heartbeat condition)
  • People with symptomatic orthostatic hypotension (low blood pressure that causes dizziness or fainting when standing up)
  • People whose blood test results at screening fall outside the ranges allowed by the trial's rules
  • People who have received anti-tau therapy or a specific Alzheimer's drug called donanemab within the 2 months before the screening visit

Important: Additional eligibility criteria apply that are not listed here. Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 16 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Phone: 858-465-7480

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 3
Sponsor
ACADIA Pharmaceuticals Inc.
Registry
ClinicalTrials.gov
Start date
14 November 2023
Est. completion
1 January 2028

Where this trial is recruiting

🇧🇷 Brazil 🇧🇬 Bulgaria 🇨🇱 Chile 🇨🇿 Czechia 🇫🇷 France 🇮🇹 Italy 🇲🇽 Mexico 🇷🇸 Serbia 🇰🇷 South Korea 🇪🇸 Spain 🇹🇼 Taiwan 🇺🇸 United States

Primary endpoints

Scale for the Assessment of Positive Symptoms-Hallucinations and Delusions subscales (SAPS-H+D) total score change from baseline (Substudies 1, 2A, 2B)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 16 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov