Genetic Evaluation for Medication Selection (GEMS) Study

NCT ID: NCT03736057

Last Updated: 2019-10-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-05-13
• Study Completion Date: 2018-08-14

Brief Summary

Investigators propose to determine whether knowing details about how a person's 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 (CYP)polymorphism 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.

Conditions

Dementia; Psychiatric Disorders Mood; Behavior Disorders

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Delayed results of pharmacogenomic results

1:1 randomization schedule for delayed knowledge of pharmacogenomic results to clinician and patient. Results are released to prescriber at \<1 week (unblinded) or 12 weeks (blinded). When genomic results are available upon receipt, unblinded clinicians select an FDA-approved drug from the "recommended" drugs when possible. Blinded prescribers provide the intended prescription when notified of blinded status. At 4 weeks, 1° outcome measures, NPI-Q and side effects ratings are collected. Clinicians make a GO/NO-GO decision for continuation based on those measures. A NO-GO decision is unblinding and an alternative drug may be prescribed. At 12 weeks, 1° outcomes are collected again. Previously blinded clinicians will be unblinded and may decide to continue or revise the treatment plan based on the clinical outcomes and the genetic results. After the 12 week visit, results of the genetic tests will be entered in the EHR. Further clinical follow-up is based on need.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Score <26 on the Alabama Brief Cognitive screen or <24 on the Montreal Cognitive Assessment.

2. Have a caregiver/informant/family member who spends at least 10 hours per week with the affected person and who is willing to participate

3. Be rated by a caregiver/informant as scoring ≥9 on the Functional Activities Questionnaire, including at least one domain score of 3 (dependent).

4. Have BPSD sufficient for the treating clinician to begin or change psychotropic drugs, and of sufficiently mild severity that a delay of 5 days before changing the prescription would not be harmful to the patient.

Exclusion Criteria

1. BPSD of sufficient severity or intensity that (in clinician's opinion) require immediate medication change or referral for emergency services

2. Lack of reliable informant with adequate exposure to patient and ability to communicate with study staff in English

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

David Geldmacher

Professor of Neurology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David Geldmacher, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

University of Alabama at Birmingham

Birmingham, Alabama, United States

Countries

United States

Other Identifiers

IRB-150902001

Identifier Type: -

Identifier Source: org_study_id