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Genetic Evaluation for Medication Selection (GEMS) Study

NCT03736057 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 40

Last updated 2019-10-07

No results posted yet for this study

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.

Conditions

  • Dementia
  • Psychiatric Disorders Mood
  • Behavior Disorders

Interventions

OTHER

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.

Sponsors & Collaborators

  • University of Alabama at Birmingham

    lead OTHER

Principal Investigators

  • David Geldmacher, MD · University of Alabama at Birmingham

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-13
Primary Completion
2018-08-14
Completion
2018-08-14

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03736057 on ClinicalTrials.gov