← Trials/Trial dossier/NCT05422885

STAMINA

CompletedPhase 1 / PHASE2Results posted

Safety and Feasibility of Dasatinib and Quercetin in Adults at Risk for Alzheimer's Disease

Senolytics To Alleviate Mobility Issues and Neurological Impairment in Aging

Lead sponsor

Lewis Lipsitz

Assets

Dasatinib / Quercetin

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criterion

•MoCA ≤21

Primary endpoints

•Neurovascular Coupling•Executive Function•Gait Speed

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

NCT IDNCT05422885

Org study IDPro00053594

Timeline

Milestones

Study start2022-05-20actual

Study first posted2022-06-21actual

Primary completion2024-01-24actual

Study completion2024-01-24actual

Last update posted2025-03-17actual

Results first posted2025-03-17actual

Assets

Drug assets

Dasatinib Quercetin

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age65 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Men and women >/= 65 years

•Ambulatory,

•Community dwelling,

•Slow gait speed (<1 m/second),

•Mild Cognitive Impairment (Telephone MoCA score <21, which is indicative of cognitive impairment)

Exclusion criteria

, or as per clinical judgment:

•Telephone MoCA score <10 points

•Unwilling to take study medications or follow study protocol

•Inability to independently perform Katz Activities of Daily Living (ADLs),

•Allergies to Dasatinib or Quercetin,

•Hospitalization within 6 months,

•Unstable coronary artery disease (myocardial infarction within 6 months or angina),

•Stroke or transient ischemic attack in the past 6 months,

•Chronic heart failure,

•Current or chronic history of liver disease,

•Neurodegenerative disease including Parkinson's disease,

•Anemia,

•Chronic renal disease,

•Drug or alcohol abuse in the last 5 years,

•QTc prolongation,

•Thrombocytopenia,

•Neutropenia,

•Prolonged prothrombin time or INR,

•Indications of current fluid retention,

•History or current diagnosis of pulmonary hypertension,

•Inability to insonate the middle cerebral artery through a temporal bone window on at least one side using transcranial Doppler ultrasound, or

•Chronic use of any of the following medications: anti-arrhythmic medications, antipsychotics, anxiolytics, anti-platelet or anti-coagulant medications other than aspirin, quinolone antibiotics, or drugs metabolized by the same liver enzymes as Quercetin or Dasatinib.

Endpoints (22)

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

Other clinical outcomes

Other (unclassified)

Global cognition

Neuroimaging

Global cognition

4 endpoints

Primary/protocol endpoint

Executive Function

Time frame:Baseline, 8, and 14 weeks

change from baseline, improvement

Primary/protocol endpoint

Montreal Cognitive Assessment (MoCA) Score

Time frame:Baseline, 8, and 14 weeks

Montreal Cognitive Assessment (MoCA)

descriptive

Primary/registry result

Executive Function

Time frame:Baseline, 8, and 14 weeks

change from baseline, improvement

Posted result

Group	Value (mean), seconds	Standard deviation
Dasatinib and QuercetinBaseline (Week 2)n=12 Participants	80.6	80.2
Week 8n=12 Participants	75.0	61.4
Week 14n=12 Participants	63.4	44.6

Primary/registry result

Montreal Cognitive Assessment (MoCA) Score

Time frame:Baseline, 8, and 14 weeks

Montreal Cognitive Assessment (MoCA)

descriptive

Posted result

Group	Value (mean), points	Standard deviation
Arm 1Baselinen=12 Participants	23	2
8 Weeksn=12 Participants	25	3
14 Weeksn=12 Participants	24	2

Neuroimaging

2 endpoints

Primary/protocol endpoint

Neurovascular Coupling

Time frame:Screening, 8, and 14 weeks

change from baseline, improvement

Primary/registry result

Neurovascular Coupling

Time frame:Screening, 8, and 14 weeks

change from baseline, improvement

Posted result

Group	Value (mean), cm/s	Standard deviation
Dasatinib and QuercetinScreeningn=12 Participants	0.68	1.40
Week 8n=12 Participants	0.26	2.04
Week 14n=12 Participants	0.80	2.13

Other clinical outcomes

10 endpoints

Primary/protocol endpoint

Gait Speed

Time frame:Baseline, 8, and 14 weeks

change from baseline, improvement

Primary/registry result

Gait Speed

Time frame:Baseline, 8, and 14 weeks

change from baseline, improvement

Posted result

Group	Value (mean), meters/second	Standard deviation
Dasatinib and QuercetinBaseline (Week 2)n=12 Participants	0.87	0.15
Week 8n=12 Participants	0.85	0.16
Week 14n=12 Participants	0.87	0.14

Secondary/protocol endpoint

Physical Performance

Time frame:Baseline, 8, and 14 weeks

descriptive

Secondary/protocol endpoint

Mobility

Time frame:Baseline, 8, and 14 weeks

descriptive

Secondary/protocol endpoint

Grip Strength

Time frame:Baseline, 8, and 14 weeks

descriptive

Secondary/protocol endpoint

Gait Speed During Cognitive Task

Time frame:Baseline, 8, and 14 weeks

descriptive

Secondary/registry result

Physical Performance

Time frame:Baseline, 8, and 14 weeks

descriptive

Posted result

Group	Value (mean), points	Standard deviation
Dasatinib and QuercetinBaseline (Week 2)n=12 Participants	9	1
Week 8n=12 Participants	9	2
Week 14n=12 Participants	9	2

Secondary/registry result

Mobility

Time frame:Baseline, 8, and 14 weeks

descriptive

Posted result

Group	Value (mean), seconds	Standard deviation
Dasatinib and QuercetinBaseline (Week 2)n=12 Participants	14.2	2.6
Week 8n=12 Participants	13.9	3.1
Week 14n=12 Participants	13.6	2.4

Secondary/registry result

Grip Strength

Time frame:Baseline, 8, and 14 weeks

descriptive

Posted result

Group	Value (mean), kilograms	Standard deviation
Dasatinib and QuercetinBaseline (Week 2)n=12 Participants	23.5	7.2
Week 8n=12 Participants	22.7	5.8
Week 14n=12 Participants	23.6	5.3

Secondary/registry result

Gait Speed During Cognitive Task

Time frame:Baseline, 8, and 14 weeks

descriptive

Posted result

Group	Value (mean), meters/second	Standard deviation
Dasatinib and QuercetinBaseline (Week 2)n=12 Participants	0.76	0.13
Week 8n=12 Participants	0.75	0.16
Week 14n=12 Participants	0.78	0.14

Other (unclassified)

6 endpoints

Secondary/protocol endpoint/low confidence

P16 ink4a Expression in CD3 Positive Cells

Time frame:Screening and 14 weeks

descriptive

Secondary/protocol endpoint/low confidence

SASP Factors in Blood and Urine

Time frame:Screening and 14 weeks

descriptive

Secondary/protocol endpoint/low confidence

SASP Factors in Blood and Urine

Time frame:Screening and 14 weeks

descriptive

Secondary/registry result/low confidence

P16 ink4a Expression in CD3 Positive Cells

Time frame:Screening and 14 weeks

descriptive

Posted result

Group	Value (mean), relative expression to housekeeping gene	Standard deviation
Dasatinib and QuercetinScreeningn=10 Participants	10.6	5.2
Week 14n=10 Participants	9.4	3.8

Secondary/registry result/low confidence

SASP Factors in Blood and Urine

Time frame:Screening and 14 weeks

descriptive

Posted result

Group	Value (mean), picograms/mL	Standard deviation
Dasatinib and QuercetinSerum IL1-alpha Screeningn=12 Participants	664.5	368.1
Serum IL1-alpha Week 14n=12 Participants	742.2	513.1
Serum IL-6 Screeningn=12 Participants	3.6	1.7
Serum IL-6 Week 14n=12 Participants	2.8	1.5

Secondary/registry result/low confidence

SASP Factors in Blood and Urine

Time frame:Screening and 14 weeks

descriptive

Posted result

Group	Value (mean), nanograms/mL	Standard deviation
Dasatinib and QuercetinSerum MMP-9 Screeningn=12 Participants	458.5	189.4
Serum MMP-9 Week 14n=12 Participants	541.6	454.4

Publications (1)

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

Millar CL, Iloputaife I, Baldyga K, Kuo J, Tchkonia T, Kirkland JL, Travison TG, Lipsitz LA. Rationale and Design of STAMINA: Senolytics To Alleviate Mobility Issues and Neurological Impairments in Aging, A Geroscience Feasibility Study. Transl Med Aging. 2023;7:109-117. doi: 10.1016/j.tma.2023.10.004. Epub 2023 Oct 21.
PMID40248131via DERIVED

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.