Intravenous umbilical cord blood cell infusion alongside standard Alzheimer's medication

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This single-center, randomized, double-blind early phase 1 trial will enroll 30 AT(N)-confirmed Alzheimer's patients and randomize them equally to low-dose, high-dose, or control groups. All participants continue conventional cholinesterase therapies while receiving one of the blinded interventions: processed umbilical cord blood mononuclear cell infusions or control. The cord blood product is obtained from a certified bank and processed to deplete erythrocytes and granulocytes to reduce immunogenicity; baseline clinical assessments, single-cell omics sampling, and optional CSF collection are planned. The study focuses on safety and preliminary signals of biological or clinical effect from the cell infusions.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age range: 50 - 75 years old, gender not restricted;
* Patients diagnosed with Alzheimer's disease (AD) according to the AT(N) diagnostic framework (with positive amyloid protein PET test results);
* MMSE score between 15 and 30 points, patients with mild to moderate Alzheimer's disease;
* The patient has a fixed caregiver who is willing to accompany the patient throughout the corresponding program;
* The patient has a literacy level above primary school, sufficient to complete the tests stipulated in the program;
* The patient or the guardian consents to participate in this clinical trial voluntarily and signs the informed consent form.

Exclusion Criteria:

* Dementia caused by other diseases, such as vascular dementia, frontotemporal dementia, and Lewy body dementia, etc.;
* The patient has other major systemic diseases, malignant tumors, chronic obstructive pulmonary disease or pulmonary fibrosis, etc. related to the lungs;
* The patient's white blood cell and neutrophil levels are below the normal lower limit;
* The patient has active infectious diseases, such as syphilis, AIDS, hepatitis B, hepatitis C;
* The patient has a history of stroke, epilepsy, alcohol abuse, or abuse of psychotropic drugs;
* Severe visual or hearing impairment, or those who cannot complete the relevant assessment due to other reasons;
* Patients who have participated in other clinical trials within the last 2 months;
* Other situations that the researchers consider not suitable for participating in clinical research.

Where it's running

• The First Affiliated Hospital of the University of Science and Technology of China
  Hefei, Anhui, China Recruiting

Study contacts

• Study coordinator: Zhaozhao Cheng
• Email: chengzz@USTC.edu.cn
• Phone: +8613965140655

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• China HEAD: a large community study on healthy aging and dementia

  This study tests whether collecting health, imaging, and biospecimen data from adults in China can help predict who will develop Alzheimer’s disease and related dementias.

  Recruiting at 30 sites Fudan University · Beijing and 29 other locations · NCT07912710

• Home-based gamma-tACS with personalized cognitive training for mild Alzheimer's disease

  This study tests a home-delivered combination of gamma-frequency tACS and individualized memory training to see if it helps people with mild Alzheimer's disease.

  Recruiting IRCCS Centro San Giovanni di Dio Fatebenefratelli · Brescia, Brescia and 1 other locations · NCT07839650

• Gut and Oral Microbiome and Cognitive Health in Aging

  This study tests whether differences in gut and mouth bacteria are linked to cognitive health in adults across ages and cognitive status.

  Recruiting University of South Florida · Tampa, Florida · NCT07799402

• Gut methane and Parkinson's: measuring if a probiotic helps people with Parkinson's, REM sleep behavior disorder, or cognitive concerns

  This study tests whether a probiotic containing Limosilactobacillus reuteri can help people with Parkinson's disease, those at high risk for PD, and related cognitive issues by potentially improving gut methane levels and overall symptoms.

  Recruiting University of Cambridge · Cambridge, CB2 · NCT07786116

• Nicotinamide Riboside by Mouth for Early Alzheimer’s Disease (2-Year Trial)

  This study tests whether taking nicotinamide riboside every day for 24 months can slow progression in adults with early Alzheimer’s disease.

  Recruiting Phase 2 Haukeland University Hospital · Bergen and 1 other locations · NCT07741071

• Rhythmic Auditory Stimulation to Improve Gait and Brain Function in Alzheimer's Disease

  A rhythm-based metronome approach is being tested to see if it helps people with Alzheimer's disease and mild cognitive impairment walk more smoothly and think more clearly.

  Recruiting Boston University Charles River Campus · Boston, Massachusetts · NCT07659964

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.