PGx Medication Safety Reviews of Persons With IDD

NCT07092852 | Not Yet Recruiting

• 1 other identifier: GRx-PGx001_CPU_2025
• Study Type: observational
• Target: 700
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to assess the feasibility of a comprehensive medication review and PGx initiative as part of the care process for individuals in the care of CP Unlimited. This initiative may help improve management of medications and overall health and well-being for participating individuals. Please note that in the context of the research being conducted, all information will remain confidential and deidentified for analyses. Under the proposed study protocol, CP Unlimited, in partnership with pharmacists at GalenusRx, will implement and assess a comprehensive medication safety and PGx initiative. Almost three quarters of all clinical trials have eligibility criteria resulting in the exclusion of adults with IDD. This study will help address ongoing health practice disparity. As indicated above, the investigators are requesting the authorization of the guardian or representative, on behalf of the participant under their supervision, to enroll this individual in the proposed study because she/he is currently prescribed medications or may eventually receive prescribed or over-the-counter medications. Hereinafter, the denomination "he/she, him/her, his/her or them/their" will be used to refer to the individual with IDD. The response to medication can be affected by variations in our genes and by other medications and various disease conditions. Information contained in our genes can vary from one patient to another patient and this can explain why we all can respond differently to medications. Genetic testing and a review of his/her medications can help to determine if the medication will work for him/her. PGx is how his/her genes affect the way he/she responds to specific drugs. PGx can tell if he/she is more or less likely to feel bad reactions to a drug, or if a drug is likely to benefit him/her and be safe for him/her to take. Knowing his/her genetic information and all medicines that he/she is taking can help his/her pharmacist and his/her doctor find the combination of medicines that will work the best for him/her, now and in the future.

Conditions

Intellectual Disability, Mild; Intellectual Disability, Mild to Moderate; Developmental Disability

Keywords

Intellectual disabilities; Developmental disabilities; IDD; pharmacogenomics

Outcome Measures

Primary Outcomes (2)

• Measure the Feasibility of PGx Testing in IDD Population

  Measure feasibility of a PGx testing program calculating the number of pharmacogenetic tests / medication safety reviews completed.

  Two years

• Measure the Acceptability of Implementing a PGx Program

  Measure the acceptability of implementing a PGx program by examining the recommendations accepted and transferred to a dispensing pharmacy.

  Two years

Secondary Outcomes (3)

• Identify the PGx Profile of CP Unlimited Patients

  Two years

• Identify Drug and Drug Classes of Drug-Gene and Drug-Drug-Gene Interactions

  Two years

• Program Feasibility Considering Data Collection

  Two years

Other Outcomes (1)

• Personalized Medication Safety Management, Genetic Results, and Acceptance

  Two years

Study Arms (1)

Residents of CP Unlimited

All persons residing in CPU facilities during the study period will be included in the study, except those who are under 21 years of age, in whom a cheek swab cannot be obtained, and those who for whom no valid consent for participation is in place.

Other: Cheek swab for PGx testing; Other: Medication safety review

Interventions

Cheek swab for PGx testing OTHER

Pharmacogenetic test kits will be provided to each CPU residence. An order will be issued to obtain samples for the study - a cheek swab - to be collected by residence direct care providers or nursing staff, trained in the procedure for obtaining the sample, and preparing and submitting it for transport. Failures to collect and submit valid samples, the number of samples submitted that cannot be processed, and the reasons for failure, will be recorded. If a submitted sample cannot be processed, another sample can be obtained and submitted.

Residents of CP Unlimited

Medication safety review OTHER

A medication reconciliation will be performed by a GalenusRx pharmacist on all included residents. Medication data for enrolled participants will be collected by the GalenusRx pharmacist from the unique pharmacy provider and/or the medication records from the facility and a medication reconciliation will be conducted with the nurse of the residents' facility. GalenusRx pharmacists will apply a CDSS to patients' medication regimens, screening for drug interactions, assess medication related risks, and consider pharmacogenomic type and phenoconversion results in recommending appropriate drug selection and dosage to prescribing clinicians.

Residents of CP Unlimited

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All persons residing in CPU facilities during the study period will be included in the study, except those who are under 21 years of age, in whom a cheek swab cannot be obtained, and those who for whom no valid consent for participation is in place. Beneficiaries will be identified by the CMO and/or the medical care team of the project. The number of persons excluded and the reasons for exclusion will be reported and analyzed. All residents have current consent for standard medical care, subject to individual 'carve-outs.' Any procedures or analyses performed on any individual in the course of this research project.

You may qualify if:

• Beneficiary with IDD
• Reside in a CP Unlimited facility, NY state
• At least 21 years of age

You may not qualify if:

• Pregnant
• Medical or physical abnormality that prevents cheek swab collection

Sponsors & Collaborators

• GalenusRx, Inc.: lead
• CP Unlimited: collaborator

Study Sites (2)

GalenusRx, Inc.

Montverde, Florida, 34756, United States

Location

CP Unlimited

The Bronx, New York, 10460, United States

Location

Related Publications (3)

• Holden B, Gitlesen JP. Psychotropic medication in adults with mental retardation: prevalence, and prescription practices. Res Dev Disabil. 2004 Nov-Dec;25(6):509-21. doi: 10.1016/j.ridd.2004.03.004.

  PMID: 15541629 BACKGROUND

• Doan TN, Lennox NG, Taylor-Gomez M, Ware RS. Medication use among Australian adults with intellectual disability in primary healthcare settings: a cross-sectional study. J Intellect Dev Disabil. 2013 Jun;38(2):177-81. doi: 10.3109/13668250.2013.778968. Epub 2013 Apr 3.

  PMID: 23550741 BACKGROUND

• Aman MG, Lam KS, Van Bourgondien ME. Medication patterns in patients with autism: temporal, regional, and demographic influences. J Child Adolesc Psychopharmacol. 2005 Feb;15(1):116-26. doi: 10.1089/cap.2005.15.116.

  PMID: 15741793 BACKGROUND

MeSH Terms

Conditions

Intellectual Disability; Lymphoma, Follicular; Developmental Disabilities

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Veronique Michaud, BPharm, MSc, PhD

  GalenusRx, Inc.

  PRINCIPAL INVESTIGATOR

• Ira Salom, MD

  CP Unlimited

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ira L Salom, MD, MSc(Med), FACP, CPE

CONTACT

718-665-7565; isalom@mchcny.org

Veronique Michaud, BPharm, MSc, PhD

CONTACT

407-497-0331; vmichaud@galenusrx.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2025
• First Posted: July 30, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): January 31, 2028
• Last Updated: July 30, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)