Trial Outcomes & Findings for Safety and Feasibility of Dasatinib and Quercetin in Adults at Risk for Alzheimer's Disease (NCT NCT05422885)
NCT ID: NCT05422885
Last Updated: 2025-03-17
Results Overview
Change in cerebral blood flow during an N-back cognitive task using transcranial doppler ultrasound.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
15 participants
Primary outcome timeframe
Screening, 8, and 14 weeks
Results posted on
2025-03-17
Participant Flow
This study was conducted from 2022-2024 in the greater Boston, MA area. Individuals were recruited through a recruitment firm that utilizes online targeted advertisements based on an individual's browsing history, as well as senior housing presentations, study flyers at clinical practices, and invitations to previous research volunteers who agreed to be in our participant registries.
Of the 332 individuals that expressed interest in the study, 115 were screened via telephone. Sixty were ineligible due to not meeting the pre-specified inclusion/exclusion criteria. Of the 55 eligible telephone screeners, 24 were not enrolled due to loss of interest (n=12), loss to follow-up (n=10), or closed enrolment (n=2). Of the 31 participants that were screened in-person, 16 were excluded for various reasons, while 15 individuals were eligible and willing to participate.
Participant milestones
| Measure |
Dasatinib and Quercetin
Participants took 100 mg of Dasatinib and 1,250 mg of Quercetin for 2 consecutive days, every two weeks for 12 weeks
|
|---|---|
|
Overall Study
STARTED
|
15
|
|
Overall Study
COMPLETED
|
12
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Dasatinib and Quercetin
Participants took 100 mg of Dasatinib and 1,250 mg of Quercetin for 2 consecutive days, every two weeks for 12 weeks
|
|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
Baseline Characteristics
Safety and Feasibility of Dasatinib and Quercetin in Adults at Risk for Alzheimer's Disease
Baseline characteristics by cohort
| Measure |
Dasatinib and Quercetin
n=15 Participants
Participants took 100 mg of Dasatinib and 1,250 mg of Quercetin for 2 consecutive days, every two weeks for 12 weeks
|
|---|---|
|
Age, Continuous
|
77 years
STANDARD_DEVIATION 7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants
|
|
Highest Level of Education
No Diploma
|
1 Participants
n=5 Participants
|
|
Highest Level of Education
Some College/Vocational School
|
1 Participants
n=5 Participants
|
|
Highest Level of Education
Associates Degree
|
1 Participants
n=5 Participants
|
|
Highest Level of Education
Bachelors Degree
|
5 Participants
n=5 Participants
|
|
Highest Level of Education
Graduate/Doctoral/Law Degree
|
7 Participants
n=5 Participants
|
|
4-meter Gait Speed
|
0.8 meters/second
STANDARD_DEVIATION 0.1 • n=5 Participants
|
|
Telephone Montreal Cognitive Assessment Score
|
17 points
STANDARD_DEVIATION 2 • n=5 Participants
|
|
Body Mass Index
|
27 kg/m^2
STANDARD_DEVIATION 4 • n=5 Participants
|
|
Osteo- or Degenerative Arthritis
|
6 Participants
n=5 Participants
|
|
High Blood Pressure
|
5 Participants
n=5 Participants
|
|
High Cholesterol
|
6 Participants
n=5 Participants
|
|
Depression
|
4 Participants
n=5 Participants
|
|
Eye Disease
|
8 Participants
n=5 Participants
|
|
Stomach Disease (e.g., Acid Reflux)
|
7 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Screening, 8, and 14 weeksChange in cerebral blood flow during an N-back cognitive task using transcranial doppler ultrasound.
Outcome measures
| Measure |
Dasatinib and Quercetin
n=12 Participants
Participants took 100 mg of Dasatinib and 1,250 mg of Quercetin for 2 consecutive days, every two weeks for 12 weeks
|
|---|---|
|
Neurovascular Coupling
Screening
|
0.68 cm/s
Standard Deviation 1.40
|
|
Neurovascular Coupling
Week 8
|
0.26 cm/s
Standard Deviation 2.04
|
|
Neurovascular Coupling
Week 14
|
0.80 cm/s
Standard Deviation 2.13
|
PRIMARY outcome
Timeframe: Baseline, 8, and 14 weeksAssess change in executive cognitive function using TRAILS test, corrected for response time. Higher scores indicate worse executive functioning.
Outcome measures
| Measure |
Dasatinib and Quercetin
n=12 Participants
Participants took 100 mg of Dasatinib and 1,250 mg of Quercetin for 2 consecutive days, every two weeks for 12 weeks
|
|---|---|
|
Executive Function
Baseline (Week 2)
|
80.6 seconds
Standard Deviation 80.2
|
|
Executive Function
Week 8
|
75.0 seconds
Standard Deviation 61.4
|
|
Executive Function
Week 14
|
63.4 seconds
Standard Deviation 44.6
|
PRIMARY outcome
Timeframe: Baseline, 8, and 14 weeksAssess change in gait speed. Performed without a distracting cognitive task.
Outcome measures
| Measure |
Dasatinib and Quercetin
n=12 Participants
Participants took 100 mg of Dasatinib and 1,250 mg of Quercetin for 2 consecutive days, every two weeks for 12 weeks
|
|---|---|
|
Gait Speed
Baseline (Week 2)
|
0.87 meters/second
Standard Deviation 0.15
|
|
Gait Speed
Week 8
|
0.85 meters/second
Standard Deviation 0.16
|
|
Gait Speed
Week 14
|
0.87 meters/second
Standard Deviation 0.14
|
PRIMARY outcome
Timeframe: Baseline, 8, and 14 weeksThe Montreal Cognitive Assessment evaluates global cognition. Scores range from 0-30 points, with higher scores indicating better cognition
Outcome measures
| Measure |
Dasatinib and Quercetin
n=12 Participants
Participants took 100 mg of Dasatinib and 1,250 mg of Quercetin for 2 consecutive days, every two weeks for 12 weeks
|
|---|---|
|
Montreal Cognitive Assessment (MoCA) Score
Baseline
|
23 points
Standard Deviation 2
|
|
Montreal Cognitive Assessment (MoCA) Score
8 Weeks
|
25 points
Standard Deviation 3
|
|
Montreal Cognitive Assessment (MoCA) Score
14 Weeks
|
24 points
Standard Deviation 2
|
SECONDARY outcome
Timeframe: Baseline, 8, and 14 weeksAssessment 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. Higher scores indicate better mobility.
Outcome measures
| Measure |
Dasatinib and Quercetin
n=12 Participants
Participants took 100 mg of Dasatinib and 1,250 mg of Quercetin for 2 consecutive days, every two weeks for 12 weeks
|
|---|---|
|
Physical Performance
Baseline (Week 2)
|
9 points
Standard Deviation 1
|
|
Physical Performance
Week 8
|
9 points
Standard Deviation 2
|
|
Physical Performance
Week 14
|
9 points
Standard Deviation 2
|
SECONDARY outcome
Timeframe: Baseline, 8, and 14 weeksTest of mobility using timed up and go test, including standing from a chair, walking, and turning.
Outcome measures
| Measure |
Dasatinib and Quercetin
n=12 Participants
Participants took 100 mg of Dasatinib and 1,250 mg of Quercetin for 2 consecutive days, every two weeks for 12 weeks
|
|---|---|
|
Mobility
Baseline (Week 2)
|
14.2 seconds
Standard Deviation 2.6
|
|
Mobility
Week 8
|
13.9 seconds
Standard Deviation 3.1
|
|
Mobility
Week 14
|
13.6 seconds
Standard Deviation 2.4
|
SECONDARY outcome
Timeframe: Baseline, 8, and 14 weeksMeasure of grip strength using a hand dynamometer.
Outcome measures
| Measure |
Dasatinib and Quercetin
n=12 Participants
Participants took 100 mg of Dasatinib and 1,250 mg of Quercetin for 2 consecutive days, every two weeks for 12 weeks
|
|---|---|
|
Grip Strength
Week 8
|
22.7 kilograms
Standard Deviation 5.8
|
|
Grip Strength
Week 14
|
23.6 kilograms
Standard Deviation 5.3
|
|
Grip Strength
Baseline (Week 2)
|
23.5 kilograms
Standard Deviation 7.2
|
SECONDARY outcome
Timeframe: Baseline, 8, and 14 weeksMeasure of gait speed during a cognitive task.
Outcome measures
| Measure |
Dasatinib and Quercetin
n=12 Participants
Participants took 100 mg of Dasatinib and 1,250 mg of Quercetin for 2 consecutive days, every two weeks for 12 weeks
|
|---|---|
|
Gait Speed During Cognitive Task
Baseline (Week 2)
|
0.76 meters/second
Standard Deviation 0.13
|
|
Gait Speed During Cognitive Task
Week 8
|
0.75 meters/second
Standard Deviation 0.16
|
|
Gait Speed During Cognitive Task
Week 14
|
0.78 meters/second
Standard Deviation 0.14
|
SECONDARY outcome
Timeframe: Screening and 14 weeksMeasure of P16 ink4a expression in senescent CD3 lymphocytes in the blood.
Outcome measures
| Measure |
Dasatinib and Quercetin
n=10 Participants
Participants took 100 mg of Dasatinib and 1,250 mg of Quercetin for 2 consecutive days, every two weeks for 12 weeks
|
|---|---|
|
P16 ink4a Expression in CD3 Positive Cells
Screening
|
10.6 relative expression to housekeeping gene
Standard Deviation 5.2
|
|
P16 ink4a Expression in CD3 Positive Cells
Week 14
|
9.4 relative expression to housekeeping gene
Standard Deviation 3.8
|
SECONDARY outcome
Timeframe: Screening and 14 weeksMeasure of the senescence-associated biomarkers IL-1alpha picogram/mL and IL-6 picogram/mL.
Outcome measures
| Measure |
Dasatinib and Quercetin
n=12 Participants
Participants took 100 mg of Dasatinib and 1,250 mg of Quercetin for 2 consecutive days, every two weeks for 12 weeks
|
|---|---|
|
SASP Factors in Blood and Urine
Serum IL1-alpha Screening
|
664.5 picograms/mL
Standard Deviation 368.1
|
|
SASP Factors in Blood and Urine
Serum IL1-alpha Week 14
|
742.2 picograms/mL
Standard Deviation 513.1
|
|
SASP Factors in Blood and Urine
Serum IL-6 Screening
|
3.6 picograms/mL
Standard Deviation 1.7
|
|
SASP Factors in Blood and Urine
Serum IL-6 Week 14
|
2.8 picograms/mL
Standard Deviation 1.5
|
SECONDARY outcome
Timeframe: Screening and 14 weeksMeasure of the senescence-associated biomarkers MMP-9 nanograms/mL and MMP-12 nanograms/mL.
Outcome measures
| Measure |
Dasatinib and Quercetin
n=12 Participants
Participants took 100 mg of Dasatinib and 1,250 mg of Quercetin for 2 consecutive days, every two weeks for 12 weeks
|
|---|---|
|
SASP Factors in Blood and Urine
Serum MMP-9 Screening
|
458.5 nanograms/mL
Standard Deviation 189.4
|
|
SASP Factors in Blood and Urine
Serum MMP-9 Week 14
|
541.6 nanograms/mL
Standard Deviation 454.4
|
Adverse Events
Dasatinib and Quercetin
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dasatinib and Quercetin
n=15 participants at risk
Participants took 100 mg of Dasatinib and 1,250 mg of Quercetin for 2 consecutive days, every two weeks for 12 weeks
|
|---|---|
|
Injury, poisoning and procedural complications
Serious Adverse Event
|
6.7%
1/15 • Number of events 1 • For all participants, adverse events were collected during the entire 14 week study. We were collecting during the period of June 2022 to January 2024, which is approximately 1 year and 8 months.
|
Other adverse events
| Measure |
Dasatinib and Quercetin
n=15 participants at risk
Participants took 100 mg of Dasatinib and 1,250 mg of Quercetin for 2 consecutive days, every two weeks for 12 weeks
|
|---|---|
|
General disorders
Headache
|
26.7%
4/15 • Number of events 5 • For all participants, adverse events were collected during the entire 14 week study. We were collecting during the period of June 2022 to January 2024, which is approximately 1 year and 8 months.
|
|
Renal and urinary disorders
Producing more urine than usual
|
6.7%
1/15 • Number of events 1 • For all participants, adverse events were collected during the entire 14 week study. We were collecting during the period of June 2022 to January 2024, which is approximately 1 year and 8 months.
|
|
Injury, poisoning and procedural complications
Bruising
|
20.0%
3/15 • Number of events 4 • For all participants, adverse events were collected during the entire 14 week study. We were collecting during the period of June 2022 to January 2024, which is approximately 1 year and 8 months.
|
|
Metabolism and nutrition disorders
High Glucose
|
13.3%
2/15 • Number of events 3 • For all participants, adverse events were collected during the entire 14 week study. We were collecting during the period of June 2022 to January 2024, which is approximately 1 year and 8 months.
|
|
Blood and lymphatic system disorders
Low White Blood Cell Count
|
20.0%
3/15 • Number of events 6 • For all participants, adverse events were collected during the entire 14 week study. We were collecting during the period of June 2022 to January 2024, which is approximately 1 year and 8 months.
|
|
Renal and urinary disorders
High Cystatin C Value
|
6.7%
1/15 • Number of events 1 • For all participants, adverse events were collected during the entire 14 week study. We were collecting during the period of June 2022 to January 2024, which is approximately 1 year and 8 months.
|
|
Renal and urinary disorders
Irregular Glomerular Filtration Rate
|
6.7%
1/15 • Number of events 2 • For all participants, adverse events were collected during the entire 14 week study. We were collecting during the period of June 2022 to January 2024, which is approximately 1 year and 8 months.
|
|
General disorders
Ankle Edema
|
6.7%
1/15 • Number of events 1 • For all participants, adverse events were collected during the entire 14 week study. We were collecting during the period of June 2022 to January 2024, which is approximately 1 year and 8 months.
|
|
Respiratory, thoracic and mediastinal disorders
Basilar Rales
|
6.7%
1/15 • Number of events 1 • For all participants, adverse events were collected during the entire 14 week study. We were collecting during the period of June 2022 to January 2024, which is approximately 1 year and 8 months.
|
|
Cardiac disorders
Irregular Heart Beat
|
6.7%
1/15 • Number of events 1 • For all participants, adverse events were collected during the entire 14 week study. We were collecting during the period of June 2022 to January 2024, which is approximately 1 year and 8 months.
|
|
Injury, poisoning and procedural complications
Muscle or Hip Pain
|
13.3%
2/15 • Number of events 2 • For all participants, adverse events were collected during the entire 14 week study. We were collecting during the period of June 2022 to January 2024, which is approximately 1 year and 8 months.
|
|
Musculoskeletal and connective tissue disorders
Difficulty with Balance
|
6.7%
1/15 • Number of events 1 • For all participants, adverse events were collected during the entire 14 week study. We were collecting during the period of June 2022 to January 2024, which is approximately 1 year and 8 months.
|
|
Psychiatric disorders
Depressed Mood or Anxiety
|
13.3%
2/15 • Number of events 2 • For all participants, adverse events were collected during the entire 14 week study. We were collecting during the period of June 2022 to January 2024, which is approximately 1 year and 8 months.
|
|
General disorders
Sore Throat
|
6.7%
1/15 • Number of events 1 • For all participants, adverse events were collected during the entire 14 week study. We were collecting during the period of June 2022 to January 2024, which is approximately 1 year and 8 months.
|
|
Respiratory, thoracic and mediastinal disorders
Difficulty Breathing
|
13.3%
2/15 • Number of events 2 • For all participants, adverse events were collected during the entire 14 week study. We were collecting during the period of June 2022 to January 2024, which is approximately 1 year and 8 months.
|
|
Blood and lymphatic system disorders
Low Hemoglobin
|
6.7%
1/15 • Number of events 2 • For all participants, adverse events were collected during the entire 14 week study. We were collecting during the period of June 2022 to January 2024, which is approximately 1 year and 8 months.
|
|
Respiratory, thoracic and mediastinal disorders
Chest Pressure
|
6.7%
1/15 • Number of events 1 • For all participants, adverse events were collected during the entire 14 week study. We were collecting during the period of June 2022 to January 2024, which is approximately 1 year and 8 months.
|
|
Blood and lymphatic system disorders
High Potassium
|
6.7%
1/15 • Number of events 1 • For all participants, adverse events were collected during the entire 14 week study. We were collecting during the period of June 2022 to January 2024, which is approximately 1 year and 8 months.
|
|
Blood and lymphatic system disorders
High Creatinine
|
13.3%
2/15 • Number of events 2 • For all participants, adverse events were collected during the entire 14 week study. We were collecting during the period of June 2022 to January 2024, which is approximately 1 year and 8 months.
|
|
Gastrointestinal disorders
Diarrhea or Loose Stool
|
33.3%
5/15 • Number of events 9 • For all participants, adverse events were collected during the entire 14 week study. We were collecting during the period of June 2022 to January 2024, which is approximately 1 year and 8 months.
|
|
Cardiac disorders
Fluttering in Chest
|
6.7%
1/15 • Number of events 1 • For all participants, adverse events were collected during the entire 14 week study. We were collecting during the period of June 2022 to January 2024, which is approximately 1 year and 8 months.
|
|
Gastrointestinal disorders
Loss of Appetite or Nausea
|
20.0%
3/15 • Number of events 8 • For all participants, adverse events were collected during the entire 14 week study. We were collecting during the period of June 2022 to January 2024, which is approximately 1 year and 8 months.
|
|
General disorders
Fatigue or Tiredness
|
40.0%
6/15 • Number of events 8 • For all participants, adverse events were collected during the entire 14 week study. We were collecting during the period of June 2022 to January 2024, which is approximately 1 year and 8 months.
|
|
General disorders
Dizziness
|
13.3%
2/15 • Number of events 2 • For all participants, adverse events were collected during the entire 14 week study. We were collecting during the period of June 2022 to January 2024, which is approximately 1 year and 8 months.
|
|
Gastrointestinal disorders
Bloating
|
6.7%
1/15 • Number of events 1 • For all participants, adverse events were collected during the entire 14 week study. We were collecting during the period of June 2022 to January 2024, which is approximately 1 year and 8 months.
|
|
Blood and lymphatic system disorders
Low Hematocrit Level
|
6.7%
1/15 • Number of events 1 • For all participants, adverse events were collected during the entire 14 week study. We were collecting during the period of June 2022 to January 2024, which is approximately 1 year and 8 months.
|
|
Nervous system disorders
Tingling in Extremeties
|
6.7%
1/15 • Number of events 1 • For all participants, adverse events were collected during the entire 14 week study. We were collecting during the period of June 2022 to January 2024, which is approximately 1 year and 8 months.
|
|
Musculoskeletal and connective tissue disorders
Sprained wrist
|
6.7%
1/15 • Number of events 1 • For all participants, adverse events were collected during the entire 14 week study. We were collecting during the period of June 2022 to January 2024, which is approximately 1 year and 8 months.
|
|
Cardiac disorders
Low blood pressure
|
6.7%
1/15 • Number of events 1 • For all participants, adverse events were collected during the entire 14 week study. We were collecting during the period of June 2022 to January 2024, which is approximately 1 year and 8 months.
|
|
Respiratory, thoracic and mediastinal disorders
Coughing
|
13.3%
2/15 • Number of events 2 • For all participants, adverse events were collected during the entire 14 week study. We were collecting during the period of June 2022 to January 2024, which is approximately 1 year and 8 months.
|
|
General disorders
Restless Sleep
|
6.7%
1/15 • Number of events 1 • For all participants, adverse events were collected during the entire 14 week study. We were collecting during the period of June 2022 to January 2024, which is approximately 1 year and 8 months.
|
|
Psychiatric disorders
Memory Concerns
|
6.7%
1/15 • Number of events 1 • For all participants, adverse events were collected during the entire 14 week study. We were collecting during the period of June 2022 to January 2024, which is approximately 1 year and 8 months.
|
|
Renal and urinary disorders
High Blood Urea Nitrogen
|
6.7%
1/15 • Number of events 1 • For all participants, adverse events were collected during the entire 14 week study. We were collecting during the period of June 2022 to January 2024, which is approximately 1 year and 8 months.
|
|
Hepatobiliary disorders
High ALT Level
|
6.7%
1/15 • Number of events 1 • For all participants, adverse events were collected during the entire 14 week study. We were collecting during the period of June 2022 to January 2024, which is approximately 1 year and 8 months.
|
|
Cardiac disorders
High Heart Rate
|
6.7%
1/15 • Number of events 1 • For all participants, adverse events were collected during the entire 14 week study. We were collecting during the period of June 2022 to January 2024, which is approximately 1 year and 8 months.
|
|
Renal and urinary disorders
Chronic Kidney Disease
|
6.7%
1/15 • Number of events 1 • For all participants, adverse events were collected during the entire 14 week study. We were collecting during the period of June 2022 to January 2024, which is approximately 1 year and 8 months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place