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

Lewis Lipsitz

Status and phase

Completed

Phase 2

Phase 1

Conditions

Aging

Treatments

Drug: Dasatinib

Drug: Quercetin

Study type

Interventional

Funder types

Other

Identifiers

NCT05422885

Pro00053594

Details and patient eligibility

About

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.

Full 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.

Enrollment

15 patients

Sex

All

Ages

65+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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, 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.