Stem Cell Therapy for Early Alzheimer's Disease

Korábbi kezelés

• 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.

Más betegség

• 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

Egyéb

• 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.

• 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.