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Recruiting NCT07512362

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

Phase II Interventional Mild Cognitive Impairment Early Alzheimer's Disease AD-MCI

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: human Mesenchymal Stem Cells.
Who it may be relevant to
Registry conditions: Mild Cognitive Impairment, Early Alzheimer's Disease, AD-MCI. Basic parameters: 55 years — 90 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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.

Overview

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

  • Biological human Mesenchymal Stem Cells
    Patients eligible to participate will receive one infusion of 25 million cells administered intravenously.

Primary outcome measures

  • Change in Alzheimer's Disease Scale-Cognitive Subscale (ADAS-Cog) [Time frame: Baseline, Week 16, Week 32, and Week 48]
Secondary outcome measures (1)
  • Change in Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory for Mild Cognitive Impairment (ADCS-MCI -ADL) [Time frame: Baseline, Week 16, Week 32, and Week 48]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • University of Miami Department of Neurology — Miami

Publications

  • Galasko D, Bennett D, Sano M, Ernesto C, Thomas R, Grundman M, Ferris S. An inventory to assess activities of daily living for clinical trials in Alzheimer's disease. The Alzheimer's Disease Cooperative Study. Alzheimer Dis Assoc Disord. 1997;11 Suppl 2:S33-9. PMID 9236950
  • doi:10.1177/1352458513475735
  • doi:10.1016/S1474-4422(15)70016-5
  • doi:10.1001/jamanetworkopen.2023.45175
  • doi:10.1016/S1474-4422(11)70305-2
  • doi:10.1212/WNL.0b013e3181b6bb95
  • Brody M, Agronin M, Herskowitz BJ, Bookheimer SY, Small GW, Hitchinson B, Ramdas K, Wishard T, McInerney KF, Vellas B, Sierra F, Jiang Z, Mcclain-Moss L, Perez C, Fuquay A, Rodriguez S, Hare JM, Oliva AA Jr, Baumel B. Results and insights from a phase I clinical trial of Lomecel-B for Alzheimer's disease. Alzheimers Dement. 2023 Jan;19(1):261-273. doi: 10.1002/alz.12651. Epub 2022 Mar 31. PMID 35357079
  • Alzheimer's Association 2024 Alzheimer's Disease Facts and Figures

Identifiers

NCT: NCT07512362 · 20251381

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗