Phase 2 Alzheimer's Disease Trial, Recruiting NCT06540833 Sponsor: Intra-Cellular Therapies, Inc. Condition: Alzheimer's Disease
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Phase 2 Alzheimer's Disease Trial, Recruiting

NCT06540833
Recruiting Phase 2

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:

  • The person must be able to understand what the trial involves and agree to take part by signing a consent form. If they are not able to do this themselves, a legally authorised representative (such as a family member) may be able to provide consent on their behalf, in line with local rules.
  • The person must meet recognised medical criteria for Alzheimer's disease, and either have blood test results suggesting Alzheimer's-related changes in the brain, or have had those changes confirmed through a spinal fluid test or a specialist brain scan.
  • The person must be showing signs of psychosis (such as delusions or hallucinations) that meet a specific international definition, as assessed at two separate points before the trial begins.
  • The person must score 2 or more on certain sections of a standard assessment tool that measures delusions and hallucinations in people with Alzheimer's disease, at two separate points before the trial begins.
  • The person must score 4 or higher on a standard scale that measures how severe their condition is overall, at two separate points before the trial begins.
  • The person must score between 6 and 24 on a standard cognitive (thinking and memory) assessment, and must be able to understand and respond to questions.
  • The person must have a designated caregiver, such as a family member, housemate, close friend, or professional carer.

Who may not be able to join:

  • People whose psychotic symptoms are mainly caused by delirium, drug or alcohol use, or another medical condition (such as a thyroid problem), or who have been diagnosed with schizophrenia, schizoaffective disorder, another psychotic disorder unrelated to Alzheimer's disease, or bipolar disorder.
  • People who are considered at risk of suicidal behaviour during the trial, who may be a danger to themselves or others, or who have made one or more suicide attempts in the two years before the screening visit.
  • People who are not able or not willing to stop taking other medications that affect the brain or nervous system, as reviewed by the study team.
  • People who are currently hospitalised or receiving specialised nursing care for a medical condition other than dementia.
  • People who are bedridden or have a serious unstable medical condition that could put them at risk from the study treatment or procedures, or that could affect how results are assessed.
  • People who are in hospice or receiving end-of-life care.

Important: 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 26 July 2026
Phase 2: approximately ~30% 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

Principal Investigator: Intra-Cellular Therapies, Inc. Clinical Trial, Intra-Cellular Therapies, Inc.

Phone: 844-434-4210

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 2
Sponsor
Intra-Cellular Therapies, Inc.
Registry
ClinicalTrials.gov
Start date
15 August 2024
Est. completion
30 September 2028

Where this trial is recruiting

🇧🇬 Bulgaria 🇭🇷 Croatia 🇨🇿 Czechia 🇵🇱 Poland 🇷🇴 Romania 🇷🇸 Serbia 🇸🇰 Slovakia 🇪🇸 Spain 🇺🇸 United States

Primary endpoints

BEHAVE-AD psychosis subscale score

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: 26 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