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

NCT06781333 | Recruiting Phase 2 FDA Drug

• 1 other identifier: 20240984
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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

Alzheimer Disease; Agitation in Dementia

Keywords

aggression; behavior; agitation

Outcome Measures

Primary Outcomes (1)

• Neuropsychiatric Inventory

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

  Up to 12 weeks.

Secondary Outcomes (2)

• Change in antipsychotic medications dosage

  Baseline to 12 weeks

• Change in number of antipsychotic medications

  Baseline to 12 weeks

Study Arms (1)

hMSC group

EXPERIMENTAL

Participants in this group will receive one infusion of hMSC. Total participation is up to 12 weeks.

Biological: hMSC

Interventions

hMSC BIOLOGICAL

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

hMSC group

Eligibility Criteria

• Age: 55 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Bernard (Barry) Baumel: lead

Study Sites (1)

University of Miami Department of Neurology

Miami, Florida, 33136, United States

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease; Aberrant Motor Behavior in Dementia; Aggression; Behavior; Psychomotor Agitation

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Behavioral Symptoms; Social Behavior; Dyskinesias; Neurologic Manifestations; Psychomotor Disorders; Neurobehavioral Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Bernard Baumel, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bernard Baumel, MD

CONTACT

(305) 243-3100; mep980@miami.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Neurology

Study Record Dates

• First Submitted: January 13, 2025
• First Posted: January 17, 2025
• Study Start: April 29, 2025
• Primary Completion (Estimated): June 15, 2026
• Study Completion (Estimated): June 15, 2026
• Last Updated: May 29, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)