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Tyrosine Kinase Inhibitor

Dasatinib + Quercetin for Alzheimer's Disease (STAMINA Trial)

Q: Is this study meant to test a hypothesis or merely observe outcomes?

The aim of this study, which will be conducted over a period of 8 to 14 weeks, is to improve executive function in patients. Secondary objectives include reducing senescence-associated biomarkers like MMP-9 and MMP-12 nanograms/mL, improving mobility through tests like the timed up and go test, and assessing physical performance with the short physical performance battery (SPPB).

Q: Are there any available vacancies for participants in this experiment?

Yes, according to the listings on clinicaltrials.gov this study is still open for recruitment. The trial was initially posted on May 20th, 2022 and has since been updated June 13th of the same year. They are only looking for 12 more patients at a single location.

Q: How large is the pool of test subjects for this clinical trial?

Yes, this is an ongoing trial that was first posted on May 20th, 2020. The last edit to the listing was June 13th, 2020. They are enrolling 12 patients in total from a single location.

Phase 1 & 2

Waitlist Available

Led By Lewis Lipsitz, MD

Research Sponsored by Lewis Lipsitz

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Slow gait speed (<1 m/second)

Ambulatory

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 8, and 14 weeks

Awards & highlights

STAMINA Trial Summary

This trial will study whether giving Dasatinib and Quercetin (D+Q) to older adults at risk of Alzheimer's disease may help improve cognition and prevent progression to Alzheimer's disease.

Who is the study for?

This trial is for older adults who can walk but have a slow gait and mild cognitive issues, suggesting they're at risk for Alzheimer's. They must be able to care for themselves daily and agree to take study medications. People with severe cognitive impairment, recent hospitalizations, certain heart conditions, other neurodegenerative diseases, or those on conflicting medications cannot participate.Check my eligibility

What is being tested?

The trial tests the safety of Dasatinib plus Quercetin (D+Q) in preventing Alzheimer's by improving brain blood flow, mobility, and cognition. Participants will receive intermittent doses of D+Q to see if these can help prevent the progression to Alzheimer's disease.See study design

What are the potential side effects?

Possible side effects from Dasatinib include fluid retention issues like swelling around the eyes or in the lungs (pulmonary edema), blood disorders such as anemia or low platelet counts. Quercetin may cause headaches and tingling in arms/legs; both could potentially lead to allergic reactions.

STAMINA Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I walk slower than 1 meter per second.

Select...

I can walk on my own without help.

STAMINA Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 8, and 14 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 8, and 14 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 8, and 14 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Executive function

Gait speed

Neurovascular coupling

Secondary outcome measures

Gait speed during cognitive task

Grip strength

Mobility

+3 more

Side effects data

From 2022 Phase 2 trial • 54 Patients • NCT03023046

26%

Febrile neutropenia

17%

Sepsis

Mucositis oral

Upper gastrointestinal hemorrhage

Intracranial hemorrhage

Hypotension

Hypertension

Enterocolitis

Atrial fibrillation

Lower gastrointestinal hemorrhage

Delirium

Oropharyngeal pain

Gastric hemorrhage

Abdominal pain

Diarrhea

Fungemia

Typhlitis

Myocardial infarction

Fibrinogen decreased

Endophthalmitis

Multi-organ failure

Kidney infection

Peripheral motor neuropathy

Hypoxia

Sinus bradycardia

Edema limbs

Small intestinal obstruction

Aspiration

100%

80%

60%

40%

20%

Study treatment Arm

Treatment (Chemotherapy)

STAMINA Trial Design

1Treatment groups

Experimental Treatment

Group I: Arm 1Experimental Treatment2 Interventions

Dasatinib and Quercetin

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Quercetin

Not yet FDA approved

Dasatinib

FDA approved

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Lewis LipsitzLead Sponsor

Lew LipsitzLead Sponsor

Lewis Lipsitz, MDPrincipal InvestigatorHebrew Senior Life

2 Previous Clinical Trials

246 Total Patients Enrolled

1 Trials studying Aging

180 Patients Enrolled for Aging

Media Library

Dasatinib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05422885 — Phase 1 & 2

Aging Clinical Trial 2023: Dasatinib Highlights & Side Effects. Trial Name: NCT05422885 — Phase 1 & 2

Dasatinib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05422885 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this study meant to test a hypothesis or merely observe outcomes?

"The aim of this study, which will be conducted over a period of 8 to 14 weeks, is to improve executive function in patients. Secondary objectives include reducing senescence-associated biomarkers like MMP-9 and MMP-12 nanograms/mL, improving mobility through tests like the timed up and go test, and assessing physical performance with the short physical performance battery (SPPB)."

Answered by AI

Are there any available vacancies for participants in this experiment?

"Yes, according to the listings on clinicaltrials.gov this study is still open for recruitment. The trial was initially posted on May 20th, 2022 and has since been updated June 13th of the same year. They are only looking for 12 more patients at a single location."

Answered by AI

How large is the pool of test subjects for this clinical trial?

"Yes, this is an ongoing trial that was first posted on May 20th, 2020. The last edit to the listing was June 13th, 2020. They are enrolling 12 patients in total from a single location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Lewis Lipsitz 2022. "Safety and Feasibility of Dasatinib and Quercetin in Adults at Risk for Alzheimer's Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05422885.