Ignite Creation Date:
2024-05-06 @ 6:56 PM
Last Modification Date:
2024-10-26 @ 2:57 PM
Study NCT ID:
NCT05838560
Status:
RECRUITING
Last Update Posted:
2023-09-05
First Post:
2023-04-17
Brief Title:
Dasatinib Plus Quercetin for Accelerated Aging in Mental Disorders
Sponsor:
Washington University School of Medicine
Organization:
Washington University School of Medicine
Study Overview
Official Title:
Dasatinib Plus Quercetin for Accelerated Aging in Mental Disorders
Status:
RECRUITING
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This pilot open-label study examines the effects of a combination of dasatinib plus quercetin - two drugs that have known senolytics properties - on physiological aging in older individuals with depression or schizophrenia
Detailed Description:
This is a pilot study that will enroll up to 40 participants and will examine the following
1 test the safety and feasibility of dasatinibquercetin in two mental illnesses associated with accelerated aging schizophrenia and treatment-resistant depression
2 examine changes in SASP senescence-associated secretory phenotype with dasatinibquercetin treatment
3 examine acute and long-term changes in neuropsychological functioning functional status and brain markers of aging as well as in clinical symptoms of the illnesses treatment-resistant depression and schizophrenia
This study will also combine the treatment of dasatinib plus quercetin and lifestyle-based risk factor management - which will involve the research team during the medication intervention portion to provide lifestyle education focusing on strength balance and nutrition The research team will maintain close contact with participants to offer encouragement address questions and help navigate barriers to engaging in the activities
Before study enrollment participants will be screened using questionnaires and a phone screen prior to being consented
The participant will be involved for about 1 year and self-administer 8 total doses of the medications - two consecutive days of dasatinib 100mg orally plus quercetin 1250mg orally on weeks 1 ie 2 days on 5 days off 2 3 and 4
The participant will undergo an MRI scan at baseline and approximately week 10 of the study
Blood draws will occur at baseline week 1 2 3 4 10 and at the endpoint 10 ml of blood will be taken each time for 700 ml over 1 year
Participants will have several questionnaires and assessments to complete at baseline week 10 and the studys endpoint
1 test the safety and feasibility of dasatinibquercetin in two mental illnesses associated with accelerated aging schizophrenia and treatment-resistant depression
2 examine changes in SASP senescence-associated secretory phenotype with dasatinibquercetin treatment
3 examine acute and long-term changes in neuropsychological functioning functional status and brain markers of aging as well as in clinical symptoms of the illnesses treatment-resistant depression and schizophrenia
This study will also combine the treatment of dasatinib plus quercetin and lifestyle-based risk factor management - which will involve the research team during the medication intervention portion to provide lifestyle education focusing on strength balance and nutrition The research team will maintain close contact with participants to offer encouragement address questions and help navigate barriers to engaging in the activities
Before study enrollment participants will be screened using questionnaires and a phone screen prior to being consented
The participant will be involved for about 1 year and self-administer 8 total doses of the medications - two consecutive days of dasatinib 100mg orally plus quercetin 1250mg orally on weeks 1 ie 2 days on 5 days off 2 3 and 4
The participant will undergo an MRI scan at baseline and approximately week 10 of the study
Blood draws will occur at baseline week 1 2 3 4 10 and at the endpoint 10 ml of blood will be taken each time for 700 ml over 1 year
Participants will have several questionnaires and assessments to complete at baseline week 10 and the studys endpoint
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None