NCT06775964RecruitingPhase 1/2
Stem Cell Therapy for Early Alzheimer's Disease
Mesenchymal Stem Cell Therapy for Early Alzheimer's Disease
Source: ClinicalTrials.gov · Last updated 20 Apr 2026
Brief summary (registry, in English)
The goal of this clinical trial is to learn if stem cell therapy works to treat brain inflammation in adults. Inflammation in the brain may be involved in adults who have memory or thinking problems. The stem cells will be taken from participant's fat samples, processed and given back to participants, so they are their own donor. The main questions this trial aims to answer are: * Does stem cell therapy reduce inflammation in the brain? * Does stem cell therapy improve brain activity? * Does stem cell therapy slow down progression to Alzheimer's disease? Participants will: * Have a small fat biopsy taken at a doctor's office to process stem cells * Receive 4 infusions of stem cells, through a vein in the arm over 12 weeks * Visit the clinic every 2-4 weeks for the first 4 months and then every 1-2 months for 8 months for checkups and tests
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 12 (estimated)
- First submitted
- 9 Jan 2025
- Start date
- 11 Mar 2026
- Primary completion date
- Jan 2027
- Lead sponsor
- Paul E Schulz
- Diseases
- Alzheimer disease
- NCT number
- NCT06775964
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 12
- From 11 Mar 2026 to the primary completion date, Jan 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Any condition, which in the opinion of the investigator, would put the subject at undue risk or would interfere with evaluation of the investigational product or interpretation of subject safety or study results.
Other illness
- Current medical or neurological condition that might impact cognition or performance on cognitive assessments. (e.g., traumatic brain injury (TBI), Parkinson's disease (PD), multiple sclerosis, etc.)
- Advanced, severe, progressive or unstable disease that may interfere with the safety, tolerability and study assessments, or put the subject at special risk. (e.g., significant cardiac disease, severe renal impairment, severe hepatic impairment, autoimmune disease, etc.)
- History of malignancy of any organ system within the past 60 months, that in the opinion of the investigator would impede evaluation or interpretation of subject safety or study results.
- Positive blood test for either HIV, Hepatitis B, Hepatitis C or Syphilis
Other
- Inability or unwillingness of patient to undergo neuropsychological testing.
- Females of childbearing potential must not be pregnant.
- Inability or unwillingness to undergo PET Scans.
- Inability or unwillingness to undergo MRI Scans.
- Positive for TSPO SNP rs6971
- Inability or unwillingness to undergo Lumbar Punctures.
- Inability or unwillingness to undergo infusions.
Who the study is looking for
- Has signed an informed consent form before any assessment is performed as part of the study.
- Be male or female between 60 and 80 years old.
- Subject has been or is in process of being clinically diagnosed with late pre-symptomatic or mild cognitive impairment (MCI) due to AD (prodromal AD).
- Mini-Mental State Examination (MMSE) score of ≥ 22
- Has an MRI to evaluate AD pathology (may use previous if within 6mo.)
- Has APOE status to evaluate AD pathology (may use previous result)
- Proficiency in English is required because cognitive tests are administered in English only.
- Has evidence of brain amyloidosis via PET Scan or Aβ42/40 ratios in CSF.
- Has evidence of peripheral inflammatory profile based on CRP (≥ 8 mg/L), IL-6 (≥ 3.1 pg/mL), TNF-α (10 pg/mL), or erythrocyte sedimentation rate (ESR) (≥20 mm/h) in blood assays.
- Is in the opinion of the Investigator, in good general medical health based upon medical history, physical examination, laboratory tests, vital signs and EKG.
Age in the registry: 60 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The University of Texas Health Science Center at Houston (UTHealth) Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.