Phase 2
Completed N=5
Senolytic Therapy to Modulate Progression of Alzheimer's Disease
Source: ClinicalTrials.gov NCT04063124 ↗Enrolled (actual)
5
Serious AEs
0.0%
Results posted
Mar 2023
Primary outcomePrimary: Brain Penetrance of Dasatinib (D) — 0.27 ng/ml
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 early Alzheimer's disease (AD). This combination of drug therapy has been shown to affect dying cells in humans with other chronic illnesses and in Alzheimer's mice models. The study team want to know if this combination of medications will reach the brain in order to evaluate if this intervention may be effective for treating AD symptoms in future studies. This is also known as a "proof of concept" study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Brain Penetrance of Dasatinib (D) |
0.27 | — |
| PRIMARY Brain Penetrance of Quercetin (Q) |
— | — |
| SECONDARY Alzheimer's Disease Marker - CSF Tau |
-21 | — |
| SECONDARY Alzheimer's Disease Marker - CSF Amyloid Beta |
78 | — |
| SECONDARY Senescence Marker IL-6 in CSF |
0.37 | — |
| SECONDARY Senescence Marker P16 in CSF |
— | — |
| SECONDARY Electronic Gait Mapping Under Single and Dual-task Conditions |
— | — |
| SECONDARY Montreal Cognitive Assessment (MoCA) |
-0.20 | — |
Eligibility Criteria
Inclusion Criteria
- 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 ( 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
Data sourced from ClinicalTrials.gov (NCT04063124). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.