Genetic Evaluation for Medication Selection (GEMS) Study
Genetic Evaluation for Medication Selection (GEMS) Study
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.
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.
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