Extended Data Table 1 |.
Eligibility criteria
| INCLUSION CRITERIA |
|---|
| Aged 50–99 years |
| Clinical diagnosis of early Alzheimer’s disease (Clinical Dementia Rating (CDR) = 0.5, Mini-Mental State Exam (MMSE) = 24 – 30) |
| If using drugs to treat symptoms related to Alzheimer’s disease, doses must be stable for at least eight weeks prior to screening visit 1 |
| Labs: |
| Adequate blood cell counts (white blood cells: 4,000 – 11,000 cells/mcL; absolute neutrophil count: 1,800–8,700 cells/mcL; platelets: 120 – 500 K/µL; hemoglobin 12.0 – 17.5 grams/dL) |
| LFTs within 2x normal value |
| CrCl ≥ 50 mL/min |
| Cholesterol (≤ 260 mg/dl), triglycerides ≤ 400 mg/dl) |
| Glucose control (HbA1c ≤ 8%) |
| Prothrombin time/partial thromboplastin time/international normalized ratio (PT/PTT/INR) within normal limits |
| Body mass index (BMI) within 16 – 35 kg/m2 |
| Reliable informant or caregiver |
| EXCLUSION CRITERIA |
| Medical or neurologic condition other than Alzheimer’s disease that may contribute to cognitive impairment |
| Clinically significant unstable psychiatric illness in the past six months |
| Hearing, vision, or motor deficits that interfere with participation |
| Alcohol or drug abuse/dependence in the past six months |
| Stroke, transient ischemic attack, or unexplained loss of consciousness in the past six months |
| Unstable angina, myocardial infarction, advanced chronic heart failure, or clinically significant conduction abnormalities within the past six months |
| Relevant brain hemorrhage, bleeding disorder and cerebrovascular abnormalities |
| Diagnosis of HIV infection or AIDS (CD4 count < 200), HIV/HBV co-infection, HBV or human T-cell leukemia virus infection |
| History of impaired renal or liver function |
| Current use of memantine or sorbitol-containing products (participants who are taken off memantine may be eligible for enrollment following a one-month washout period) |
| HIV, HBV, or current/previous use of NRTIs/non-NRTIs |
| Poorly controlled blood pressure (systolic > 160, diastolic > 90 mmHg) |
| Uncontrolled diabetes (HbA1c > 8%, or current use of insulin) |
| Significant systematic illness or infection in the past 30 days |
| Pregnant women |
| Space-occupying lesion in brain that contraindicates LP |
| Imaging within one year prior to enrollment that identifies any exclusionary lesions |