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SToMP-AD

CompletedPhase 1 / PHASE2Results posted

Senolytic 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 diseaseMoCA 10-20AD symptomatic therapy: stableMRI 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

Org study IDHSC20190222H
NCT IDNCT04063124

Timeline

Milestones

Study first posted2019-08-21actual
Study start2020-02-14actual
Primary completion2021-12-10actual
Study completion2023-01-30actual
Last update posted2023-03-06actual
Results first posted2023-03-06actual

Assets

Drug assets

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age65 Years
SexAll
Healthy volunteersNot accepted

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

Fluid / digital biomarkers
10
Global cognition
2
Amyloid biomarkers
2
Other clinical outcomes
2

Global cognition

2 endpoints
Secondary/protocol endpoint

Montreal Cognitive Assessment (MoCA)

Time frame:Change from 0 to 12 weeks

Montreal Cognitive Assessment (MoCA)

descriptive

Secondary/registry result

Montreal Cognitive Assessment (MoCA)

Time frame:Change from 0 to 12 weeks

Montreal Cognitive Assessment (MoCA)

descriptive

Posted result

GroupValue (mean), pointsStandard deviation
Intermittent D+Qn=5 Participants-0.202.28

Amyloid biomarkers

2 endpoints
Secondary/protocol endpoint

Alzheimer's Disease Marker - CSF Amyloid Beta

Time frame:Change from 0 to 12 weeks

descriptive

Secondary/registry result

Alzheimer's Disease Marker - CSF Amyloid Beta

Time frame:Change from 0 to 12 weeks

descriptive

Posted result

GroupValue (mean), pg/mlStandard deviation
Intermittent D+Qn=5 Participants7875

Fluid / digital biomarkers

10 endpoints
Primary/protocol endpoint

Brain Penetrance of Dasatinib (D)

Time frame:Change from 0 to 12 weeks

descriptive

Primary/protocol endpoint

Brain Penetrance of Quercetin (Q)

Time frame:Change from 0 to 12 weeks

descriptive

Primary/registry result

Brain Penetrance of Dasatinib (D)

Time frame:Change from 0 to 12 weeks

descriptive

Posted result

GroupValue (mean), ng/mlStandard deviation
Intermittent D+Qn=5 Participants0.270.19
Primary/registry result

Brain Penetrance of Quercetin (Q)

Time frame:Change from 0 to 12 weeks

descriptive

Posted result

GroupValue (mean), ng/mlStandard deviation
Intermittent D+Qn=5 Participants00
Secondary/protocol endpoint

Alzheimer's Disease Marker - CSF Tau

Time frame:Change from 0 to 12 weeks

descriptive

Secondary/protocol endpoint

Senescence Marker IL-6 in CSF

Time frame:Change from 0 to 12 weeks

descriptive

Secondary/protocol endpoint

Senescence Marker P16 in CSF

Time frame:Change from 0 to 12 weeks

descriptive

Secondary/registry result

Alzheimer's Disease Marker - CSF Tau

Time frame:Change from 0 to 12 weeks

descriptive

Posted result

GroupValue (mean), pg/mlStandard deviation
Intermittent D+Qn=5 Participants-2135
Secondary/registry result

Senescence Marker IL-6 in CSF

Time frame:Change from 0 to 12 weeks

descriptive

Posted result

GroupValue (mean), pg/mlStandard deviation
Intermittent D+Qn=5 Participants0.370.20
Secondary/registry result

Senescence Marker P16 in CSF

Time frame:Change from 0 to 12 weeks

descriptive

Other clinical outcomes

2 endpoints
Secondary/protocol endpoint

Electronic Gait Mapping Under Single and Dual-task Conditions

Time frame:Change from 0 to 12 weeks

descriptive

Secondary/registry result

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

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableClinicalTrials.gov results section

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.