University of Miami Department of Neurology
Miami, Florida, 33136, United States
Location status: Recruiting
Location contact
Bernard S Baumel, MD
PRINCIPAL_INVESTIGATOR
Maria E. Puertas, CRC
CONTACT
NCT Number: NCT07512362
The purpose of this study is to test if adding one infusion of (Human Mesenchymal Stem Cells) hMSCs to the treatment with standard of care (SOC) monoclonal antibodies (mAb) will stabilize the rate of cognitive and functional decline associated with mild Alzheimer's Disease.
Interested in participating?
Request Info55 year–90 year
All sexes
Interventional
Phase 2
Miami, Florida, 33136, United States
Location status: Recruiting
Bernard S Baumel, MD
PRINCIPAL_INVESTIGATOR
Maria E. Puertas, CRC
CONTACT
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients eligible to participate will receive one infusion of 25 million cells administered intravenously.
Time frame: Baseline, Week 16, Week 32, and Week 48
The Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog-11) is a validated performance-based instrument used to assess the severity of cognitive impairment in individuals with Alzheimer's disease. The scale evaluates multiple cognitive domains, including memory, reasoning, language, orientation, ideational praxis, and constructional praxis. Spoken language, language comprehension, word-finding ability, and the ability to remember instructions are also assessed. Scores range from 0 to 70, with higher scores indicating greater cognitive impairment.
Time frame: Baseline, Week 16, Week 32, and Week 48
The Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory for Mild Cognitive Impairment (ADCS-MCI-ADL) is an 18-item caregiver-reported instrument assessing basic and instrumental daily activities. Total scores range from 0 to 57, with higher scores indicating greater functional independence.
Contact information is provided by the study sponsor or research team.
Bernard (Barry) Baumel
Other
A Pilot Study to Assess the Effect of Adding 1 Infusion of Human Mesenchymal Stem Cells (hMSC) to Patients Treated With Anti-Amyloid Monoclonal Antibodies Who Are Suffering From Mild Cognitive Impairment or Mild Alzheimer's Disease.
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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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