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NCT Number: NCT06781333

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

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.

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Key information

Conditions

Alzheimer Disease Aberrant Motor Behavior in Dementia Aggression Agitation in Dementia Behavior Behavioral Symptoms Brain Diseases Central Nervous System Diseases Dementia Dyskinesias Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurodegenerative Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Psychomotor Agitation Psychomotor Disorders Signs and Symptoms Social Behavior Tauopathies

Age range

55 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults 55-90 years at the time of signing consent
  • A diagnosis of probable Alzheimer disease (AD), defined by the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria
  • Previous computed tomography or magnetic resonance imaging scan of the brain with findings consistent with a diagnosis of Alzheimer disease
  • A diagnosis of behavioral symptoms that include any of the following: delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, aberrant motor behavior, sleep and nighttime behavior disorders and appetite and eating disorders
  • Onset of behavioral symptoms at least 4 weeks prior to screening.
  • Treatment with antipsychotic medication for at least 4 weeks prior to the hMSC infusion.
  • Patients unable to consent should have a Legally Authorized Representative or Proxy to provide consent on their behalf.
  • Have a family member or friend (study partner) who has frequent and sufficient contact with the patient and able to answer questions about the participant's behavior.

Exclusion criteria

  • Dementia other than AD
  • Patient with severe depression. Patient with controlled depression is allowed to participate.
  • Recent history of substance abuse
  • History of bleeding disorders, HIV, Hepatitis C Virus or Hepatitis B Virus
  • Recent history (within 3 years) of malignancies, except for treated basal cell, squamous carcinoma or melanoma in situ, prostate in situ, cervical carcinoma in situ.
  • Uncontrolled medical conditions (hypertension, diabetes, unstable angina or Myocardial Infarction within 1 year prior to screening)
  • History of bleeding disorder
  • Currently receiving (or received within four weeks of screening) experimental agents for the treatment of Alzheimer's Disease or enrolled in clinical trials in the prior 3 months.
  • Be a transplant recipient or in any other active medical condition than in the opinion of the investigator may compromise the safety or compliance of the patient or preclude successful completion of the study
  • Be premenopausal

Treatment and study plan

hMSC

Biological

Participants will come in person to receive one intravenous infusion of approximately 25 million cells up to 20 minutes.

Primary outcomes

  1. Neuropsychiatric Inventory

    Time frame: Up to 12 weeks.

    Score ranges from 0-12, higher scores indicate a worse psychiatric outcome

Secondary outcomes

  1. Change in antipsychotic medications dosage

    Time frame: Baseline to 12 weeks

    Will be measured in milligrams

  2. Change in number of antipsychotic medications

    Time frame: Baseline to 12 weeks

    Will be measured in number of antipsychotic medications

Study contacts

Contact information is provided by the study sponsor or research team.

Bernard Baumel, MD

CONTACT

[email protected]

(305) 243-3100

Sponsors and collaborators

Lead sponsor

Bernard (Barry) Baumel

Other

Registry information

Official study title

A Pilot Study to Assess the Effect of Adding 1 Infusion of Human Mesenchymal Stem Cells (hMSC) to the Treatment of Patients Suffering Agitation/Aggression or Other Behavioral Abnormalities From Alzheimer's Disease.

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jan 17, 2025
Registry last updated
May 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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