Ignite Creation Date:
2024-05-06 @ 12:20 PM
Last Modification Date:
2024-10-26 @ 12:57 PM
Study NCT ID:
NCT03736057
Status:
COMPLETED
Last Update Posted:
2019-10-07
First Post:
2018-10-09
Brief Title:
Genetic Evaluation for Medication Selection GEMS Study
Sponsor:
University of Alabama at Birmingham
Organization:
University of Alabama at Birmingham
Study Overview
Official Title:
Pharmacogenic Guidance to Optimize Safety and Efficacy of Psychotropic Drug Use in Treatment of Behavioral and Psychiatric Symptoms in Dementia
Status:
COMPLETED
Status Verified Date:
2019-10
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:
GEMS
Brief Summary:
Investigators propose to determine whether knowing details about how a persons genes affect the way medicines work in the brain and body will help doctors pick more effective or safer medicine for that person Target symptoms are restlessness agitation depression and related problems common in people with memory loss and dementia
Detailed Description:
This project offers an innovative approach to improving treatment outcomes for people with Behavioral and psychiatric symptoms of dementia BPSD as well as a novel electronic health record EHR -compatible means of assessing treatment response To date there has been limited investigation of pharmacogenomic testing among people with dementia Testing has mostly been focused on testing a single Cytochrome P450 CYPpolymorphism to guide treatment decisions for cognitive enhancing cholinesterase inhibitor medications in patients with Alzheimer disease Pharmacogenomic guidance of prescribing decisions for psychotropic medications has not been studied for BPSD but there is growing evidence that such analyses can assist in effective prescription decisions for treatment of depression Since affective symptoms are among the most prominent drivers of BPSD and associated distress and the highest level evidence for successful treatment of BPSD is with the antidepressant drug citalopram investigators believe that pharmacogenomic guidance for selection of drugs to treat BPSD is truly innovative and will provide new insights on implementing safer and more effective treatment for BPSD
Additionally investigators will explore the use of the NIH-sponsored Patient Reported Outcomes measurement Information System PROMIS as an outcome measure for BPSD PROMIS is a system of highly reliable valid flexible precise and responsive assessment tools that measure patient-reported health status PROMIS measures are available for typical BPSD like anger anxiety and depression but their utility has not been studied in a sample of dementia patients They offer the potential through patient-portal EHR interfaces for clinicians to track treatment responses in a more timely and efficient manner than traditional clinic-based instruments placing less burden on patients and families to present for in-clinic assessments
Additionally investigators will explore the use of the NIH-sponsored Patient Reported Outcomes measurement Information System PROMIS as an outcome measure for BPSD PROMIS is a system of highly reliable valid flexible precise and responsive assessment tools that measure patient-reported health status PROMIS measures are available for typical BPSD like anger anxiety and depression but their utility has not been studied in a sample of dementia patients They offer the potential through patient-portal EHR interfaces for clinicians to track treatment responses in a more timely and efficient manner than traditional clinic-based instruments placing less burden on patients and families to present for in-clinic assessments
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None