Actively Recruiting

Phase 2
Age: 55Years - 90Years
All Genders
NCT06781333

Human Mesenchymal Stem Cells (hMSC) in Behavioral Problems Due to Alzheimer's Disease.

Led by Bernard (Barry) Baumel · Updated on 2025-05-29

8

Participants Needed

1

Research Sites

58 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The purpose of this research study is to test if adding one infusion of mesenchymal stem cells to the current treatment with antipsychotic medication may help control behavioral problems in people with a diagnosis of moderate to severe Alzheimer's disease.

CONDITIONS

Official Title

Human Mesenchymal Stem Cells (hMSC) in Behavioral Problems Due to Alzheimer's Disease.

Who Can Participate

Age: 55Years - 90Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 55 to 90 years at the time of consent
  • Diagnosis of probable Alzheimer's disease based on established criteria
  • Previous brain imaging consistent with Alzheimer's disease
  • Behavioral symptoms including delusions, hallucinations, agitation, depression, anxiety, euphoria, apathy, disinhibition, irritability, abnormal motor behavior, sleep or eating disorders
  • Behavioral symptoms started at least 4 weeks before screening
  • Treatment with antipsychotic medication for at least 4 weeks before the infusion
  • Consent provided by patient or legally authorized representative
  • Have a family member or friend who frequently interacts with the patient and can report on behavior
Not Eligible

You will not qualify if you...

  • Diagnosis of dementia other than Alzheimer's disease
  • Severe depression (controlled depression allowed)
  • Recent substance abuse
  • History of bleeding disorders, HIV, Hepatitis B or C
  • History of malignancies within 3 years except certain treated skin and in situ cancers
  • Uncontrolled medical conditions such as hypertension, diabetes, unstable angina, or recent heart attack
  • Receiving experimental Alzheimer's treatments or enrolled in trials within last 3 months
  • Transplant recipient or other active medical conditions that may affect safety or study completion
  • Premenopausal women

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of Miami Department of Neurology

Miami, Florida, United States, 33136

Actively Recruiting

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Research Team

B

Bernard Baumel, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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