Senolytic Therapy to Modulate Progression of Alzheimer's Disease

Launched by THE UNIVERSITY OF TEXAS HEALTH SCIENCE CENTER AT SAN ANTONIO · Aug 16, 2019

Keywords

ClinConnect Summary

Up to 40 potential candidates will be pre-screened to identify eligible men and women ages 65 years and over with a clinical diagnosis of early AD on a stable dose of cholinesterase inhibitors for at least 3 months (for example, Aricept).

Eligible participants will undergo laboratory assessments of blood and urine, receive study medications over a twelve week period, and complete pre- and post-treatment testing including: an MRI for digital imaging of the brain; lumbar puncture to obtain cerebrospinal fluid; memory and thinking assessments; quality of life questionnaires; and tests of walk...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age 65 years or above.
• • 2. Clinical diagnosis of AD (MoCA 10-20 and Clinical Dementia Rating Scale/CDR = 1) on a stable dose of cholinesterase inhibitors for at least three months
• • 3. Body Mass Index (BMI) within range of 19 - 35 kg/ m2
• • 4. Labs: Normal blood cell counts without clinically significant excursions (WBCs: 4,500-10,500 cells/mcL; absolute neutrophil count: 1,800-8,700 cells/mcL; platelets: 140-450 K/uL; hemoglobin 12.0-17.5 grams/dL); liver and renal function (AST 10-40 IU/L, total bilirubin 0.1-1.4 mg/dl); cholesterol (\<240 mg/dl), triglycerides (\<300 mg/dl), and glucose control (HbA1c \< 7%). PT/PTT/INR within normal limits
• • 5. Participants must be accompanied by a Legally Authorized Representative designated to sign informed consent and to provide study partner reported outcomes at all remaining visits
• • 6. Participants must have no plans to travel over the next 4-5 months that interfere with study visits following consent
• Exclusion Criteria:
• • 1. Hearing, vision, or motor deficits despite corrective devices;
• • 2. Alcohol or drug abuse;
• • 3. MRI contraindications;
• • 4. Myocardial infarction, angina, stroke or transient ischemic attack in the past 6 months; QT interval \>440 on ECG will not be enrolled. Chronic heart failure will be exclusionary;
• • 5. Participants with coagulation disorders;
• • 6. Neurologic, musculoskeletal, or other condition that limits subject's ability to complete study physical assessments;
• • 7. Uncontrolled diabetes (HbA1c \> 7% or the current use of insulin);
• • 8. Current or chronic history of liver disease, or known hepatic or biliary abnormalities;
• • 9. Use of anti-arrhythmic medications known to cause QTc prolongation, anti-platelet or anti-coagulant medication;
• • 10. Current use of quinolone antibiotics.
• • 11. Poorly controlled blood pressure (systolic BP\>160, diastolic BP\>90 mmHg).
• • 12. Active inflammatory, autoimmune, infectious, hepatic, gastrointestinal, malignant, and psychiatric disease.
• • 13. History of or MRI-positive for any space occupying lesion, including mass effect or abnormal intracranial pressure, which would indicate contraindication to lumbar puncture