Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:14 PM
Ignite Modification Date:
2025-12-24 @ 1:14 PM
NCT ID:
NCT04552795
Eligibility Criteria:
Inclusion Criteria:
1. Aged 50-99 years
2. Clinical diagnosis of early Alzheimer's disease (Clinical Dementia Rating (CDR) = 0.5, Mini-Mental State Exam (MMSE) = 24-30)
3. 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
4. Labs: Adequate blood cell counts (white blood cells: 4,000-111,000 cells per microliter (cells/mcL); absolute neutrophil count: 1,800-8,700 cells/mcL; platelets: 120-500 K/µL; hemoglobin 12.0-17.5 grams/dL); LFT's within 2x normal value; creatinine clearance test (CrCl) ≥ 50 mL/min; cholesterol (≤260 mg/dl), triglycerides≤ 400 mg/dl), and glucose control (HbA1c ≤ 8%). Prothrombin time/partial thromboplastin time/international normalized ratio (PT/PTT/INR) within normal limits
5. Body mass index (BMI) within range of 19 - 35 kg/m2
6. Must have a reliable informant or caregiver
7. Participants must have no plans to travel that interfere with study visits
Exclusion Criteria:
1. Any medical or neurologic condition (other than Alzheimer's Disease) that might be a contributing cause of the subject's cognitive impairment
2. Clinically significant unstable psychiatric illness in the past six months
3. Significant hearing, vision, or motor deficits that interfere with participation
4. Alcohol or drug abuse/dependence in the past six months
5. Stroke, transient ischemic attack, or unexplained loss of consciousness in the past six months
6. Unstable angina, myocardial infarction, advanced chronic heart failure, or clinically significant conduction abnormalities within the past six months
7. Relevant brain hemorrhage, bleeding disorder and cerebrovascular abnormalities
8. Diagnosis of HIV infection or AIDS (CD4 count \< 200), HIV/Hepatitis B Virus (HBV) co-infection, HBV or human T-cell leukemia virus infection
9. History of impaired renal or liver function
10. Current use of memantine or sorbitol-containing products
11. Individuals with HIV, HBV, or who have current/previous use of Nucleoside Reverse Transcriptase Inhibitors (NRTIs) or non-NRTIs.
12. Poorly controlled blood pressure (BP) (systolic BP \> 160, diastolic BP \> 90 mmHg)
13. Uncontrolled diabetes (HbA1c \> 8%, or the current use of insulin)
14. Significant systematic illness or infection in the past 30 days
15. Pregnant women
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
80 Years
Study:
NCT04552795
Study Brief:
Protocol Section:
NCT04552795