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

NCT ID: NCT05422885

Last Updated: 2025-03-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-20
• Study Completion Date: 2024-01-24

Brief 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). 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.

Conditions

Aging

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Arm 1

Dasatinib and Quercetin

Group Type: EXPERIMENTAL

Dasatinib

Intervention Type: DRUG

Dasatinib 100 mg for 2 consecutive days, every two weeks for 12 weeks

Quercetin

Intervention Type: DRUG

Quercetin 1,250 mg for 2 consecutive days, every two weeks for 12 weeks

Interventions

Dasatinib

Dasatinib 100 mg for 2 consecutive days, every two weeks for 12 weeks

Intervention Type: DRUG

Quercetin

Quercetin 1,250 mg for 2 consecutive days, every two weeks for 12 weeks

Intervention Type: DRUG

Other Intervention Names

Sprycel

Eligibility Criteria

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

• 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.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lewis Lipsitz

OTHER

Sponsor Role: lead

Responsible Party

Lewis Lipsitz

Director, Marcus Institute for Aging Research

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Lewis Lipsitz, MD

Role: PRINCIPAL_INVESTIGATOR

Hebrew Senior Life

Locations

Hebrew Senior Life

Boston, Massachusetts, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 40248131 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Informed Consent Form

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

Pro00053594

Identifier Type: -

Identifier Source: org_study_id