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Senolytic
Senolytic Therapy for Alzheimer's Disease (SToMP-AD Trial)
Phase 2
Recruiting
Led By Suzanne Craft, PhD
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Must speak English fluently and have at least six years of formal education
Diagnosis of amnestic mild cognitive impairment (aMCI) or early Alzheimer's disease (AD)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to week 48
Awards & highlights
SToMP-AD Trial Summary
This trial will test whether senolytics are safe and effective in treating early Alzheimer's disease.
Who is the study for?
This trial is for adults aged 65 and older with mild cognitive impairment or early-stage Alzheimer's Disease, who have elevated tau protein levels. Participants must be on a stable dose of FDA-approved AD medications for at least three months, able to consent (or have a representative), and have a study partner. They should not plan extensive travel during the study and must speak English fluently.Check my eligibility
What is being tested?
The SToMP-AD Study is testing the safety and effectiveness of senolytic therapy using Dasatinib plus Quercetin compared to placebo capsules in slowing down Alzheimer's progression in patients with positive tau PET scans.See study design
What are the potential side effects?
Potential side effects may include changes in blood cell counts, liver or kidney function issues due to Dasatinib + Quercetin treatment. Specific side effects are not listed but will relate to the known profiles of these drugs.
SToMP-AD Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I speak English fluently and have completed at least six years of school.
Select...
I have been diagnosed with early Alzheimer's or mild cognitive impairment.
Select...
I am 65 years old or older.
SToMP-AD Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to week 48
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to week 48
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Serious Adverse Events (SAEs) and Adverse Events (AEs) in treatment group as compared to placebo group
Secondary outcome measures
Change in Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) slope
Change in Positron Emission Tomography (PET) - Computed Tomography (CT) - brain tau pathology
Change in cellular senescence blood marker Cluster of Differentiation 3 (CD3) in blood
+4 moreSide effects data
From 2023 Phase 1 & 2 trial • 5 Patients • NCT0406312440%
Urinary tract infection
20%
Hematuria
20%
Emesis
20%
Hypoglycemia
20%
Fall
20%
Diarrhea
100%
80%
60%
40%
20%
0%
Study treatment Arm
Intermittent D+Q
SToMP-AD Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: TreatmentExperimental Treatment1 Intervention
Dasatinib (D) is given as (1) 100mg capsule daily for 2 consecutive days (Sprycel®, Bristol Myers Squibb). Quercetin (Q) will be given as (4) 250 mg capsules daily (total 1000 mg daily) for the same 2 consecutive days (Thorne Research). Both are administered orally.
Group II: PlaceboPlacebo Group1 Intervention
Matching placebo capsules following the same administration protocol as the experimental treatment - administered once daily (1st dose of each cycle will be given, supervised, at the clinic visit; the 2nd dose will be taken at home) for 2 consecutive days followed by a 13-day (+/- 2 day) no-drug period for 12 consecutive weeks for 6 rounds of administration.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dasatinib + Quercetin
2016
Completed Phase 2
~40
Find a Location
Who is running the clinical trial?
Wake Forest University Health SciencesLead Sponsor
1,242 Previous Clinical Trials
1,004,219 Total Patients Enrolled
The University of Texas Health Science Center at San AntonioOTHER
452 Previous Clinical Trials
91,362 Total Patients Enrolled
Suzanne Craft, PhDPrincipal InvestigatorWake Forest University Health Sciences
16 Previous Clinical Trials
2,019 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had a heart attack, chest pain, stroke, or mini-stroke in the last 6 months.You cannot have an MRI if you are claustrophobic, have metal implants, or a cardiac pacemaker.I cannot take medicine by mouth.Your heart's electrical activity takes longer than usual.Your total cholesterol should be less than 240 mg/dl, and your HbA1c level should be 7% or lower.I am on blood thinners other than low-dose aspirin.Your blood clotting tests (PT/PTT/INR) are normal.I can stop my acid reflux medication for 2 days during treatment, or I'm okay using antacids instead.I do not have major neurological conditions other than early Alzheimer's.I have been on a stable dose of FDA-approved Alzheimer's medication for at least 3 months.I have been diagnosed with chronic heart failure.I have been on a stable dose of FDA-approved Alzheimer's medication for at least 3 months.People of all ethnic backgrounds can participate.My gender does not affect my eligibility.I have someone who can be my study partner and is available to help for about 10 hours a week.I speak English fluently and have completed at least six years of school.You have had problems with alcohol or drugs in the past 2 years.I can stop my current medications for 2 days for the study.I am not on medications that strongly affect liver enzymes.Your tau protein levels in your cerebrospinal fluid are higher than normal.I have been diagnosed with early Alzheimer's or mild cognitive impairment.I am currently on medication that includes chemotherapy drugs.My diabetes is not well-controlled, with HbA1c over 7% or I'm on insulin/sulfonylureas.You have a body mass index (BMI) higher than 40.Your blood pressure is not well controlled and is consistently high.Your kidney function is severely reduced, with an estimated glomerular filtration rate (eGFR) less than 10 ml per minute per 1.73 square meters.I can sign the consent form myself or have someone legally authorized to do it for me.I am 65 years old or older.My liver is not functioning well, with high bilirubin levels.You need to have normal blood cell counts, liver function, and kidney function.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: Treatment
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are Dasatinib + Quercetin results unique, or have other drugs been studied in this way?
"At present, there are 70 active studies investigating the effects of Dasatinib + Quercetin. Of these, 9 are currently in Phase 3. Many of the locations for these trials are based in New york City; however, there are 4264 total research sites for this combination drug therapy."
Answered by AI
What are the most common side effects of Dasatinib + Quercetin?
"Dasatinib + Quercetin, which is currently in Phase 2 trials, received a safety score of 2. This means that while there is no data supporting efficacy, there are promising signs when it comes to safety."
Answered by AI
How many research subjects are needed for this investigation?
"That is correct. The information available on clinicaltrials.gov verifies that this trial, which was first advertised on December 22nd 2021, has open enrolment at the moment. They are looking for 48 individuals total at just 1 site."
Answered by AI
Are people with the required condition still able to enroll in this clinical trial?
"That is correct. The clinical trial, which has currently open enrollment, was first posted on December 22nd, 2021 and updated most recently on January 21st, 2022. They are looking for a total of 48 participants that will be coming from 1 site."
Answered by AI
Who else is applying?
What state do they live in?
North Carolina
How old are they?
18 - 65
What site did they apply to?
Wake Forest Health Sciences
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0
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