Status:
COMPLETED
Senolytic Therapy to Modulate Progression of Alzheimer's Disease
Lead Sponsor:
The University of Texas Health Science Center at San Antonio
Collaborating Sponsors:
Mayo Clinic
Conditions:
Alzheimer Disease
Eligibility:
All Genders
65+ years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this pilot study is to evaluate whether a combination of two drugs, dasatinib (D) and quercetin (Q) \[D+Q\], penetrate the brain using cerebrospinal fluid (CSF) in older adults with ear...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- Age 65 years or above.
- 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
- Body Mass Index (BMI) within range of 19 - 35 kg/ m2
- 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
- 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
- Participants must have no plans to travel over the next 4-5 months that interfere with study visits following consent
Exclusion
- Hearing, vision, or motor deficits despite corrective devices;
- Alcohol or drug abuse;
- MRI contraindications;
- 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;
- Participants with coagulation disorders;
- Neurologic, musculoskeletal, or other condition that limits subject's ability to complete study physical assessments;
- Uncontrolled diabetes (HbA1c \> 7% or the current use of insulin);
- Current or chronic history of liver disease, or known hepatic or biliary abnormalities;
- Use of anti-arrhythmic medications known to cause QTc prolongation, anti-platelet or anti-coagulant medication;
- Current use of quinolone antibiotics.
- Poorly controlled blood pressure (systolic BP\>160, diastolic BP\>90 mmHg).
- Active inflammatory, autoimmune, infectious, hepatic, gastrointestinal, malignant, and psychiatric disease.
- History of or MRI-positive for any space occupying lesion, including mass effect or abnormal intracranial pressure, which would indicate contraindication to lumbar puncture
Key Trial Info
Start Date :
February 14 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 30 2023
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT04063124
Start Date
February 14 2020
End Date
January 30 2023
Last Update
March 6 2023
Active Locations (1)
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1
Glenn Biggs Institute for Alzheimer's & Neurodegenerative Diseases
San Antonio, Texas, United States, 78229