Cognitive Dysfunction study: AdMSC
Official title Stem Cell Therapy for Early Alzheimer's Disease
ClinicalTrials.gov ID: NCT06775964
What this study is testing
What is adMSC?
This is an investigational treatment being studied to see if it helps with cognitive dysfunction and brain inflammation.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study aims to find out if stem cell therapy lowers brain inflammation, improves brain activity, or slows the progression of Alzheimer's disease.
- Who it's for
- The study is looking for adults who have memory or thinking problems that may be caused by brain inflammation.
- What's involved
- Participants will have a small fat sample taken to collect their own stem cells. They will then receive four infusions of these cells through a vein in the arm.
- Time commitment
- The study lasts about 12 months, with clinic visits every 2-4 weeks for the first 4 months and every 1-2 months for the next 8 months.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 12 weeks
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 60 to 80
You may be able to join if
- 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.)
You likely can't join if
- Current medical or neurological condition that might impact cognition or performance on cognitive assessments.
- Inability or unwillingness of patient to undergo neuropsychological testing.
- Advanced, severe, progressive or unstable disease that may interfere with the safety, side effects and study assessments, or put the subject at...
- History of malignancy of any organ system within the past 60 months, that in the opinion of the investigator would impede evaluation or...
- Females of childbearing potential must not be pregnant.
- Inability or unwillingness to undergo PET Scans.
See the full eligibility criteria
- 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.
- 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.)
- Inability or unwillingness of patient to undergo neuropsychological testing.
- Advanced, severe, progressive or unstable disease that may interfere with the safety, side effects and study assessments, or put the subject at special risk.
- 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.
- Females of childbearing potential must not be pregnant.
- Inability or unwillingness to undergo PET Scans.
- Inability or unwillingness to undergo MRI Scans.
- Positive blood test for either HIV, Hepatitis B, Hepatitis C or Syphilis
- Positive for TSPO SNP rs6971
- Inability or unwillingness to undergo Lumbar Punctures.
- Inability or unwillingness to undergo infusions.
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The study runs about 12 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 60 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Houston, Texas, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.