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

NCT05422885 | Completed Phase 1 Results DMC FDA Drug

• 1 other identifier: Pro00053594
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Aging

Keywords

Alzheimer's disease; Senescence

Outcome Measures

Primary Outcomes (4)

• Neurovascular Coupling

  Change in cerebral blood flow during an N-back cognitive task using transcranial doppler ultrasound.

  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.

  Baseline, 8, and 14 weeks

• Gait Speed

  Assess change in gait speed. Performed without a distracting cognitive task.

  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

  Baseline, 8, and 14 weeks

Secondary Outcomes (7)

• Physical Performance

  Baseline, 8, and 14 weeks

• Mobility

  Baseline, 8, and 14 weeks

• Grip Strength

  Baseline, 8, and 14 weeks

• Gait Speed During Cognitive Task

  Baseline, 8, and 14 weeks

• P16 ink4a Expression in CD3 Positive Cells

  Screening and 14 weeks

Study Arms (1)

Arm 1

EXPERIMENTAL

Dasatinib and Quercetin

Drug: Dasatinib; Drug: Quercetin

Interventions

Dasatinib DRUG

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

Also known as: Sprycel

Arm 1

Quercetin DRUG

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

Arm 1

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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,

Sponsors & Collaborators

• Lewis Lipsitz: lead

Study Sites (1)

Hebrew Senior Life

Boston, Massachusetts, 02131, United States

Location

Related Publications (1)

• 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.

  PMID: 40248131 DERIVED

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Dasatinib; Quercetin

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines; Flavonols; Flavonoids; Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Limitations and Caveats

Although we collected urine samples, the SASP factors (i.e., biomarkers) we were not measured due to insufficient funds and resources. Therefore, we are unable to analyze any data.

Results Point of Contact

• Title: Courtney Millar
• Organization: Marcus Institute

courtneymillar@hsl.harvard.edu

6179715531

Study Officials

• Lewis Lipsitz, MD

  Hebrew Senior Life

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director, Marcus Institute for Aging Research

Study Record Dates

• First Submitted: March 14, 2022
• First Posted: June 21, 2022
• Study Start: May 20, 2022
• Primary Completion: January 24, 2024
• Study Completion: January 24, 2024
• Last Updated: March 17, 2025
• Results First Posted: March 17, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share

Locations

US (1)