Genetic Evaluation for Medication Selection (GEMS) Study

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