Genetic Evaluation for Medication Selection (GEMS) Study

NCT03736057 | Completed

• 1 other identifier: IRB-150902001
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Dementia; Psychiatric Disorders Mood; Behavior Disorders

Outcome Measures

Primary Outcomes (2)

• Psychiatric Symptoms of Dementia

  Comparison from baseline Neuropsychiatric Inventory-Questionnaire (NPI-Q) and the 12-week follow-up. Neuropsychiatric Inventory-Questionnaire is a questionnaire completed by caregivers about patients designed to measure both neuropsychiatric symptoms (e.g., agitation/aggression, anxiety, hallucinations). There are 12 symptoms included in NPI-Q. Each domain includes an initial response of "yes" or "no". If "yes", then the caregiver rates the severity of the symptom on a 3-point scale (1= mild, 2=moderate and 3=severe). The NPI-Q provides a total severity score ranged 0-36 with higher scores indicating more severe symptoms.

  12 weeks

• Behavioral Symptoms of Dementia

  Comparison from baseline Patient Reported Outcomes Measurement Information System (PROMIS) and the 12-week follow-up. This assessment is a self- or informant-rated measure that ascertains mental health domains that are important across psychiatric diagnoses. The scale is used as screener for symptoms severity of the following domains: Anger, anxiety, depression and sleep disturbance. Each item on the measure is rated on a 5-point scale with higher scores reflect greater symptom severity. A rating of mild (i.e., 2) or greater on any item within a domain may serve as a guide for additional inquiry and follow up to determine if a more detailed assessment for that domain is necessary. On the subscales noted above, The raw scores should be summed to obtain a total raw score and identify the associated T-score The T-scores are interpreted as follows: Less than 55 = None to slight 55.0-59.9 = Mild 60.0-69.9 = Moderate 70 and over = Severe

  12 weeks

Interventions

Delayed results of pharmacogenomic results OTHER

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.

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

As director of the Division of Memory Disorders, PI Dr. Geldmacher leads the effort of the four neurologists and two nurse practitioners who provide clinical services at the UAB Memory Disorders Clinic (MDC). During 2013, there were 1595 total outpatient MDC visits for patients with dementia-related diagnoses. A sample of 100 consecutive MDC patients from April 2015 demonstrated that 69 were treated with psychotropic agents, including antidepressants (n=67), antipsychotics (n=6), or both.

You may qualify if:

• Score \<26 on the Alabama Brief Cognitive screen or \<24 on the Montreal Cognitive Assessment.
• Have a caregiver/informant/family member who spends at least 10 hours per week with the affected person and who is willing to participate
• Be rated by a caregiver/informant as scoring ≥9 on the Functional Activities Questionnaire, including at least one domain score of 3 (dependent).
• 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.

You may not qualify if:

• BPSD of sufficient severity or intensity that (in clinician's opinion) require immediate medication change or referral for emergency services
• Lack of reliable informant with adequate exposure to patient and ability to communicate with study staff in English

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Saliva by cheek swab and/spit cup

MeSH Terms

Conditions

Dementia; Mood Disorders; Mental Disorders

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders

Study Officials

• David Geldmacher, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Neurology

Study Record Dates

• First Submitted: October 9, 2018
• First Posted: November 8, 2018
• Study Start: May 13, 2016
• Primary Completion: August 14, 2018
• Study Completion: August 14, 2018
• Last Updated: October 7, 2019

Record last verified: 2019-10

Locations

US (1)