Phase 2 Alzheimer's Disease Trial, Recruiting NCT07512362 Sponsor: Bernard (Barry) Baumel Condition: Alzheimer's Disease
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Phase 2 Alzheimer's Disease Trial, Recruiting

NCT07512362
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 old at the time of signing the consent form
  • People who have been diagnosed with Mild Cognitive Impairment or mild Alzheimer's disease-related dementia
  • People who have been receiving an FDA-approved Alzheimer's antibody treatment — either Lecanemab (Leqembi) or Donanemab (Kisunla) — for at least 6 months before the infusion visit
  • People who score between 20 and 26 on a standard memory and thinking test called the MMSE
  • People who are able to give their own informed consent to participate
  • People who have a family member or close friend (called a "study partner") who has regular, meaningful contact with them and can answer questions about their daily activities as part of the study

Who may not be able to join:

  • People whose dementia is caused by something other than Alzheimer's disease
  • People with severe, uncontrolled depression (those with depression that is well-managed may still be considered)
  • People who are unable to independently give informed consent to participate
  • People with a recent history of substance abuse
  • People with a history of bleeding disorders, HIV, Hepatitis C (HCV), or Hepatitis B (HBV)
  • People who have had cancer in the last 3 years, with some exceptions for certain treated skin cancers or early-stage 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 four weeks, any experimental Alzheimer's treatment, or who have participated in another clinical trial within the past 3 months
  • People who have received an organ transplant, or who have another active medical condition that the trial doctor believes could affect safety or the ability to complete the study
  • People who are premenopausal (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 27 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 S. 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
15 May 2026
Est. completion
15 June 2028

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Change in Alzheimer's Disease Scale-Cognitive Subscale (ADAS-Cog)

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: 27 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