AD-MCI, Early Alzheimer's Disease, Mild Cognitive Impairment
Conditions
Keywords
Mild Cognitive Impairment, MCI, AD-MCI, Early Alzheimer's Disease
Brief summary
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.
Interventions
BIOLOGICALhuman Mesenchymal Stem Cells
Patients eligible to participate will receive one infusion of 25 million cells administered intravenously.
Sponsors
Bernard (Barry) Baumel
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
55 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Adults 55-90 years at the time of signing consent * Patients diagnosed with Mild Cognitive Impairment or mild Dementia due to Alzheimer disease, receiving treatment with an FDA approved monoclonal antibody (Leqembi/Lecanemab or Kisunla/Donanemab) for at least 6 months prior to the infusion visit. * MMSE score 20-26. * Patients must be able to consent. * Have a family member or friend (study partner) who has frequent and sufficient contact with the patient and is able to answer questions about the participant's daily activities to complete the ADCS-MCI-ADL. Completing this scale is required to assess the impact of the study intervention on cognitive function and daily living skills in this patient population. Having a study partner is a requirement of this study.
Exclusion criteria
* Dementia other than AD * Patient with severe depression. Patients with controlled depression are allowed to participate. * Inability to independently provide informed consent is considered exclusionary per protocol requirements * Recent history of substance abuse * History of bleeding disorders, HIV, HCV or HBV * 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 MI 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Alzheimer's Disease Scale-Cognitive Subscale (ADAS-Cog) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory for Mild Cognitive Impairment (ADCS-MCI -ADL) | 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. |
Countries
United States
Contacts
CONTACTMaria E. Puertas
PRINCIPAL_INVESTIGATORBernard S. Baumel, MD
University of Miami
Outcome results
None listed