Phase 2 Alzheimer's Disease Trial, Recruiting NCT06781333 Sponsor: Bernard (Barry) Baumel Condition: Alzheimer's Disease
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Phase 2 Alzheimer's Disease Trial, Recruiting

NCT06781333
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:

  • Adults between 55 and 90 years of age at the time of signing the consent form
  • People who have been diagnosed with probable Alzheimer's disease, based on a specific set of recognised medical guidelines (NINCDS-ADRDA criteria)
  • People who have previously had a brain scan (CT or MRI) with results that are consistent with an Alzheimer's disease diagnosis
  • People who have been diagnosed with behavioural symptoms related to their condition, such as delusions, hallucinations, agitation, aggression, depression, anxiety, apathy, irritability, unusual repetitive movements, sleep disturbances, or changes in appetite or eating
  • People whose behavioural symptoms began at least 4 weeks before the initial screening appointment
  • People who have been taking antipsychotic medication for at least 4 weeks before the treatment infusion
  • People who are unable to consent for themselves may still be considered, provided a legally authorised representative or proxy is available to provide consent on their behalf
  • People who have a family member or close friend who has regular, meaningful contact with them and is able to answer questions about their behaviour during the trial

Who may not be able to join:

  • People whose dementia is caused by something other than Alzheimer's disease
  • People with severe depression (those with depression that is well-managed and under control may still be considered)
  • People with a recent history of substance abuse
  • People with a history of bleeding disorders, HIV, Hepatitis C, or Hepatitis B
  • People who have had cancer within the past 3 years, with some exceptions for certain treated skin cancers or other specific in-situ cancers (confirm with trial site)
  • People with uncontrolled high blood pressure, uncontrolled diabetes, unstable chest pain (angina), or a heart attack within the past year
  • People who are currently taking, or have taken within the past 4 weeks, experimental treatments for Alzheimer's disease, or who have participated in another clinical trial within the past 3 months
  • People who have received an organ or tissue transplant, or who have another active medical condition that the trial doctor believes could affect their safety or their ability to complete the study
  • People who have not yet gone through menopause

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 9 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: Bernard Baumel, MD, University of Miami

Phone: (305) 243-3100

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
Bernard (Barry) Baumel
Registry
ClinicalTrials.gov
Start date
29 April 2025
Est. completion
15 December 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Neuropsychiatric Inventory

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: 9 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