← Trials/Trial dossier/NCT04063124
SToMP-AD
CompletedPhase 1 / PHASE2Results postedSenolytic Therapy to Modulate Progression of Alzheimer's Disease
Pilot Study to Investigate the Safety and Feasibility of Senolytic Therapy to Modulate Progression of Alzheimer's Disease (SToMP-AD)
Asset
Dasatinib + Quercetin
Listed sites
1
Recruiting sites
-
Enrollment
5
actual
Study population
Alzheimer’s disease
Key I/E criteria
•Alzheimer's disease•MoCA 10-20•AD symptomatic therapy: stable•MRI contraindications excluded
Primary endpoints
•Brain Penetrance of Dasatinib (D)•Brain Penetrance of Quercetin (Q)
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Drug assets
Study populations
Who this study enrolls
Eligibility
Who can enroll
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
Endpoints (16)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Global cognition
2 endpointsMontreal Cognitive Assessment (MoCA)
Time frame:Change from 0 to 12 weeks
Montreal Cognitive Assessment (MoCA)
descriptive
Montreal Cognitive Assessment (MoCA)
Time frame:Change from 0 to 12 weeks
Montreal Cognitive Assessment (MoCA)
descriptive
Posted result
| Group | Value (mean), points | Standard deviation |
|---|---|---|
| Intermittent D+Qn=5 Participants | -0.20 | 2.28 |
Amyloid biomarkers
2 endpointsAlzheimer's Disease Marker - CSF Amyloid Beta
Time frame:Change from 0 to 12 weeks
descriptive
Alzheimer's Disease Marker - CSF Amyloid Beta
Time frame:Change from 0 to 12 weeks
descriptive
Posted result
| Group | Value (mean), pg/ml | Standard deviation |
|---|---|---|
| Intermittent D+Qn=5 Participants | 78 | 75 |
Fluid / digital biomarkers
10 endpointsBrain Penetrance of Dasatinib (D)
Time frame:Change from 0 to 12 weeks
descriptive
Brain Penetrance of Quercetin (Q)
Time frame:Change from 0 to 12 weeks
descriptive
Brain Penetrance of Dasatinib (D)
Time frame:Change from 0 to 12 weeks
descriptive
Posted result
| Group | Value (mean), ng/ml | Standard deviation |
|---|---|---|
| Intermittent D+Qn=5 Participants | 0.27 | 0.19 |
Brain Penetrance of Quercetin (Q)
Time frame:Change from 0 to 12 weeks
descriptive
Posted result
| Group | Value (mean), ng/ml | Standard deviation |
|---|---|---|
| Intermittent D+Qn=5 Participants | 0 | 0 |
Alzheimer's Disease Marker - CSF Tau
Time frame:Change from 0 to 12 weeks
descriptive
Senescence Marker IL-6 in CSF
Time frame:Change from 0 to 12 weeks
descriptive
Senescence Marker P16 in CSF
Time frame:Change from 0 to 12 weeks
descriptive
Alzheimer's Disease Marker - CSF Tau
Time frame:Change from 0 to 12 weeks
descriptive
Posted result
| Group | Value (mean), pg/ml | Standard deviation |
|---|---|---|
| Intermittent D+Qn=5 Participants | -21 | 35 |
Senescence Marker IL-6 in CSF
Time frame:Change from 0 to 12 weeks
descriptive
Posted result
| Group | Value (mean), pg/ml | Standard deviation |
|---|---|---|
| Intermittent D+Qn=5 Participants | 0.37 | 0.20 |
Senescence Marker P16 in CSF
Time frame:Change from 0 to 12 weeks
descriptive
Other clinical outcomes
2 endpointsElectronic Gait Mapping Under Single and Dual-task Conditions
Time frame:Change from 0 to 12 weeks
descriptive
Electronic Gait Mapping Under Single and Dual-task Conditions
Time frame:Change from 0 to 12 weeks
descriptive
Publications (7)
Bibliography
Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.
Registry references + supporting bibliography
- PMID34687726via DERIVED
- PMID37679434via DERIVED
- PMID35098970via DERIVED
- PMID40274471via DERIVED
- PMID37437986via DERIVED
- PMID38496619via DERIVED
- PMID40009460via DERIVED
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.