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New treatment option for Cognitive Dysfunction
Official title Stem Cell Therapy for Early Alzheimer's Disease
ClinicalTrials.gov ID: NCT06775964
What this study is testing
What is adMSC?
adMSC is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for cognitive dysfunction.
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
- 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.
- 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. (e.g., traumatic brain injury (TBI)...
- 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. (e.g., significant cardiac disease, severe renal impairment...
- 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's taking place
- 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 - 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?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.