Clinical trial NCT03736057: Genetic Evaluation for Medication Selection (GEMS) Study
Official title: Pharmacogenic Guidance to Optimize Safety and Efficacy of Psychotropic Drug Use in Treatment of Behavioral and Psychiatric Symptoms in Dementia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dementia
Psychiatric Disorders Mood
Behavior Disorders
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2018-11-08
Enrollment: 40
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Psychiatric Symptoms of Dementia
timeFrame: 12 weeks
measure: Behavioral Symptoms of Dementia
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: David Geldmacher, MD
role: PRINCIPAL_INVESTIGATOR
References: