AgingPhase 1/2STAMINANCT05422885
Safety and Feasibility of Dasatinib and Quercetin in Adults at Risk for Alzheimer's Disease
A Phase 1/2 study testing Dasatinib and Quercetin in people with Aging, run by Lewis Lipsitz at 1 site in United States.
Trial summary
The purpose of this pilot study is to demonstrate the safety and feasibility of administering intermittent doses of Dasatinib and Quercetin (D+Q) in older adults at risk of Alzheimer's disease (AD). Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Aging
- What is being tested?
- Dasatinib and Quercetin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 20 May 2022to 24 Jan 2024
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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)
Who cannot join
- 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),
Show all 21Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Senolytics To Alleviate Mobility Issues and Neurological Impairment in Aging
The purpose of this pilot study is to demonstrate the safety and feasibility of administering intermittent doses of Dasatinib and Quercetin (D+Q) in older adults at risk of Alzheimer's disease (AD). The study will evaluate whether giving D+Q may improve cerebral blood flow regulation, mobility, and cognition in older adults, and thus may prevent progression to Alzheimer's disease.
Read the detailed description
The investigators will conduct a 12-week single arm, open label, pre-post pilot study in 12 adults aged 65 or older with slow gait speed (<1.0 m/sec) and Mild Cognitive Impairment (MCI, defined as a Telephone Montreal Cognitive Assessment Score (MoCA) <19). Participants will be asked to take 100mg of Dasatinib and 1,250mg of Quercetin for 2 consecutive days, every two weeks over a period of 12 weeks (12 doses in total, given over 6 cycles).
At baseline, enrolled participants will undergo gait speed and neurocognitive testing, and provide blood and urine to evaluate biomarkers of senescence. At visits 3,4, 6, and 7, participants will have safety labs drawn, and the study team will assess medication adherence and adverse events. At visits 2, 5, and 8, participants will undergo cognitive assessments, gait speed testing, cerebral blood flow and neurovascular coupling testing. At the final study visit, participants will again provide blood and urine to assess biomarkers of senescence.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DasatinibDrug
Also called Sprycel
Dasatinib 100 mg for 2 consecutive days, every two weeks for 12 weeks
QuercetinDrug
Quercetin 1,250 mg for 2 consecutive days, every two weeks for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Dasatinib and Quercetin Receives: Drug: Dasatinib; Drug: Quercetin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurovascular Coupling
Change in cerebral blood flow during an N-back cognitive task using transcranial doppler ultrasound.
Measured: Screening, 8, and 14 weeks
Executive Function
Assess change in executive cognitive function using TRAILS test, corrected for response time. Higher scores indicate worse executive functioning.
Measured: Baseline, 8, and 14 weeks
Gait Speed
Assess change in gait speed. Performed without a distracting cognitive task.
Measured: Baseline, 8, and 14 weeks
Montreal Cognitive Assessment (MoCA) Score
The Montreal Cognitive Assessment evaluates global cognition. Scores range from 0-30 points, with higher scores indicating better cognition
Measured: Baseline, 8, and 14 weeks
Secondary outcomes (7)
Physical Performance
Assessment of overall physical function using the short physical performance battery (SPPB) scored from 0-12, based on a composite of balance, strength, and walking speed. Higher scores indicate better mobility.
Measured: Baseline, 8, and 14 weeks
Mobility
Test of mobility using timed up and go test, including standing from a chair, walking, and turning.
Measured: Baseline, 8, and 14 weeks
Grip Strength
Measure of grip strength using a hand dynamometer.
Measured: Baseline, 8, and 14 weeks
Gait Speed During Cognitive Task
Measure of gait speed during a cognitive task.
Measured: Baseline, 8, and 14 weeks
P16 ink4a Expression in CD3 Positive Cells
Measure of P16 ink4a expression in senescent CD3 lymphocytes in the blood.
Measured: Screening and 14 weeks
SASP Factors in Blood and Urine
Measure of the senescence-associated biomarkers IL-1alpha picogram/mL and IL-6 picogram/mL.
Measured: Screening and 14 weeks
SASP Factors in Blood and Urine
Measure of the senescence-associated biomarkers MMP-9 nanograms/mL and MMP-12 nanograms/mL.
Measured: Screening and 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2022
- Study start20 May 2022
- Primary completion24 Jan 2024
- Study completion24 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lewis Lipsitz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lewis Lipsitz, Hebrew SeniorLife
- Investigators
- Lewis Lipsitz, MD, Principal investigator, Hebrew Senior Life
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05422885
- Sponsor's protocol ID
- Pro00053594
- Acronym
- STAMINA
- Status last verified
- Feb 2025
- First submitted
- 14 Mar 2022
- Last updated
- 17 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 40248131
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Senolytics To Alleviate Mobility Issues and Neurological Impairment in Aging
- ClinicalTrials.gov ID
- NCT05422885
- Acronym / sponsor ID
- STAMINA / Pro00053594
- Conditions
- Aging
- Keywords
- Alzheimer's disease, Senescence
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Lewis LipsitzUniversity, hospital or other
- Study start
- 20 May 2022 (actual)
- Primary completion
- 24 Jan 2024 (actual)
- Study completion
- 24 Jan 2024 (actual)
- First posted
- 21 Jun 2022 (actual)
- Results
- Posted 17 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this pilot study is to demonstrate the safety and feasibility of administering intermittent doses of Dasatinib and Quercetin (D+Q) in older adults at risk of Alzheimer's disease (AD). The study will evaluate whether giving D+Q may improve cerebral blood flow regulation, mobility, and cognition in older adults, and thus may prevent progression to Alzheimer's disease.
Detailed description
The investigators will conduct a 12-week single arm, open label, pre-post pilot study in 12 adults aged 65 or older with slow gait speed (<1.0 m/sec) and Mild Cognitive Impairment (MCI, defined as a Telephone Montreal Cognitive Assessment Score (MoCA) <19). Participants will be asked to take 100mg of Dasatinib and 1,250mg of Quercetin for 2 consecutive days, every two weeks over a period of 12 weeks (12 doses in total, given over 6 cycles).
At baseline, enrolled participants will undergo gait speed and neurocognitive testing, and provide blood and urine to evaluate biomarkers of senescence. At visits 3,4, 6, and 7, participants will have safety labs drawn, and the study team will assess medication adherence and adverse events. At visits 2, 5, and 8, participants will undergo cognitive assessments, gait speed testing, cerebral blood flow and neurovascular coupling testing. At the final study visit, participants will again provide blood and urine to assess biomarkers of senescence.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Dasatinib, Drug: QuercetinDasatinib and Quercetin |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (21 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DasatinibAlso: SprycelDasatinib 100 mg for 2 consecutive days, every two weeks for 12 weeks | Drug | Arm 1 |
| QuercetinQuercetin 1,250 mg for 2 consecutive days, every two weeks for 12 weeks | Drug | Arm 1 |
Primary outcome
Neurovascular Coupling
Time frame: Screening, 8, and 14 weeks
Change in cerebral blood flow during an N-back cognitive task using transcranial doppler ultrasound.
Executive Function
Time frame: Baseline, 8, and 14 weeks
Assess change in executive cognitive function using TRAILS test, corrected for response time. Higher scores indicate worse executive functioning.
Gait Speed
Time frame: Baseline, 8, and 14 weeks
Assess change in gait speed. Performed without a distracting cognitive task.
Montreal Cognitive Assessment (MoCA) Score
Time frame: Baseline, 8, and 14 weeks
The Montreal Cognitive Assessment evaluates global cognition. Scores range from 0-30 points, with higher scores indicating better cognition
7 secondary outcomes
Physical Performance
Time frame: Baseline, 8, and 14 weeks
Mobility
Time frame: Baseline, 8, and 14 weeks
Grip Strength
Time frame: Baseline, 8, and 14 weeks
Gait Speed During Cognitive Task
Time frame: Baseline, 8, and 14 weeks
P16 ink4a Expression in CD3 Positive Cells
Time frame: Screening and 14 weeks
SASP Factors in Blood and Urine
Time frame: Screening and 14 weeks
SASP Factors in Blood and Urine
Time frame: Screening and 14 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40248131Millar 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lewis Lipsitz, MD principal investigator
Hebrew Senior Life
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Dasatinib and Quercetin in people with Aging, run by Lewis Lipsitz at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neurovascular Coupling (time frame: Screening, 8, and 14 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05422885, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2025.