Human Mesenchymal Stem Cells & Monoclonal Antibodies in the Treatment for Mild Cognitive Impairment or Early Alzheimer's Disease.

Bernard (Barry) Baumel

Status and phase

Enrolling

Phase 2

Conditions

AD-MCI

Mild Cognitive Impairment

Early Alzheimer's Disease

Treatments

Biological: human Mesenchymal Stem Cells

Study type

Interventional

Funder types

Other

Identifiers

NCT07512362

20251381

Details and patient eligibility

About

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.

Enrollment

10 estimated patients

Sex

All

Ages

55 to 90 years old

Volunteers

No Healthy Volunteers

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