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

Primary Purpose

Aging

Status

Recruiting

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Dasatinib

Quercetin

About this trial

This is an interventional prevention trial for Aging focused on measuring Alzheimer's disease, Senescence

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Ambulatory,
Community dwelling,
Slow gait speed (<1 m/second),
Mild Cognitive Impairment (Telephone MoCA score <19, 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.

Sites / Locations

Hebrew Senior LifeRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm 1

Arm Description

Dasatinib and Quercetin

Outcomes

Primary Outcome Measures

Neurovascular coupling

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

Executive function

Assess change in executive cognitive function using TRAILS test, corrected for response time

Gait speed

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

Secondary Outcome Measures

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.

Mobility

Test of mobility using timed up and go test, including standing from a chair, walking, and turning.

Grip strength

Measure of grip strength using a hand dynamometer.

Gait speed during cognitive task

Measure of gait speed during a cognitive task.

Senescent CD3 cells expressing p16

Measure of the number of senescent CD3 lymphocytes in the blood.

SASP factors in blood and urine

Measure of the senescence-associated biomarkers IL-1alpha picogram/mL and IL-6 picogram/mL.

SASP factors in blood and urine

Measure of the senescence-associated biomarkers MMP-9 nanograms/mL and MMP-12 nanograms/mL.

Full Information

NCT ID

NCT05422885

First Posted

March 14, 2022

Last Updated

May 25, 2023

Sponsor

Lew Lipsitz

1. Study Identification

Unique Protocol Identification Number

NCT05422885

Brief Title

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

Acronym

STAMINA

Official Title

Senolytics To Alleviate Mobility Issues and Neurological Impairment in Aging

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Recruiting

Study Start Date

May 20, 2022 (Actual)

Primary Completion Date

June 1, 2024 (Anticipated)

Study Completion Date

June 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Lew Lipsitz

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Aging

Keywords

Alzheimer's disease, Senescence

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm 1

Arm Type

Experimental

Arm Description

Dasatinib and Quercetin

Intervention Type

Drug

Intervention Name(s)

Dasatinib

Other Intervention Name(s)

Sprycel

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Quercetin

Intervention Description

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

Primary Outcome Measure Information:

Title

Neurovascular coupling

Description

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

Time Frame

Screening, 8, and 14 weeks

Title

Executive function

Description

Assess change in executive cognitive function using TRAILS test, corrected for response time

Time Frame

Baseline, 8, and 14 weeks

Title

Gait speed

Description

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

Time Frame

Screening, 8, and 14 weeks

Secondary Outcome Measure Information:

Title

Physical performance

Description

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.

Time Frame

Baseline, 8, and 14 weeks

Title

Mobility

Description

Test of mobility using timed up and go test, including standing from a chair, walking, and turning.

Time Frame

Baseline, 8, and 14 weeks

Title

Grip strength

Description

Measure of grip strength using a hand dynamometer.

Time Frame

Baseline, 8, and 14 weeks

Title

Gait speed during cognitive task

Description

Measure of gait speed during a cognitive task.

Time Frame

Baseline, 8, and 14 weeks

Title

Senescent CD3 cells expressing p16

Description

Measure of the number of senescent CD3 lymphocytes in the blood.

Time Frame

Screening and 14 weeks

Title

SASP factors in blood and urine

Description

Measure of the senescence-associated biomarkers IL-1alpha picogram/mL and IL-6 picogram/mL.

Time Frame

Screening and 14 weeks

Title

SASP factors in blood and urine

Description

Measure of the senescence-associated biomarkers MMP-9 nanograms/mL and MMP-12 nanograms/mL.

Time Frame

Screening and 14 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Ambulatory, Community dwelling, Slow gait speed (<1 m/second), Mild Cognitive Impairment (Telephone MoCA score <19, 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Kathryn Baldyga

Phone

6179715380

kathrynbaldyga@hsl.harvard.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Ikechukwu Iloputaife

Phone

6179715305

iloputaife@hsl.harvard.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lewis Lipsitz, MD

Organizational Affiliation

Hebrew Senior Life

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hebrew Senior Life

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02131

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Katie Baldyga

First Name & Middle Initial & Last Name & Degree

Ike Iloputaife

12. IPD Sharing Statement

Plan to Share IPD

Yes

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

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