Computational Drug Repurposing for AD/ADRD with Integrative Analysis of Real-World Data and Biomedical Knowledge

Study Updated 03/28/2024

Study Design: Retrospective Observational
PCORnet Infrastructure: Collaboration, CDM (+supplemental data), Engagement
Principal Investigator: Jiang Bian
Site Name: University of Florida and University of Florida Health
PCORnet® Network Partner: OneFlorida+
Funder: NIH
Funding Date: 2022
Study Duration: 2022 – 2027
Participating Clinical Research Networks: INSIGHT, OneFlorida+
Therapeutic Area: Neurosciences
Condition: Dementia
Population: 18 Years and older (Adult,  Older Adult )
Status: Active, not recruiting

Research Question(s): Can existing drugs be repurposed to treat Alzheimer’s disease and related dementia?

Primary Publication(s):

Newer glucose-lowering drugs and risk of dementia: A systematic review and meta-analysis of observational studies
Tang H, Shao H, Shaaban CE, et al. Newer glucose-lowering drugs and risk of dementia: A systematic review and meta-analysis of observational studies. J Am Geriatr Soc. 2023;71(7):2096-2106. doi: 10.1111/jgs.18306.

Assess the documentation of cognitive tests and biomarkers in electronic health records via natural language processing for Alzheimer’s disease and related dementias
Chen Z, Zhang H, Yang X, et al. Assess the documentation of cognitive tests and biomarkers in electronic health records via natural language processing for Alzheimer’s disease and related dementias. Int J Med Inform. 2023. doi: 10.1016/j.ijmedinf.2022.104973.

PANDA – MSD: Predictive Analytics via Networked Distributed Algorithms for Multi – System Diseases

Study Updated 03/28/2024

Study Design: Retrospective Observational
PCORnet Infrastructure: Collaboration, CDM, Engagement
Principal Investigator: Jiang Bian
Site Name: University of Florida and University of Florida Health
PCORnet® Network Partner: OneFlorida+
Funder: NIH
Funding Date: 2022
Study Duration: 2022 – 2026
Participating Clinical Research Networks: OneFlorida+, STAR
Therapeutic Area: Rare Disease
Condition: Granulomatosis with Polyangiitis (GPA); Psoriatic Arthritis (PsA)
Population: 18 Years and older (Adult, Older Adult )
Status: Recruiting

Research Question(s):
Can the use of EHR data develop predictive tools to assist healthcare providers in reaching earlier diagnoses and interventions, and improve the diagnostic journey and clinical outcomes of patients with rare diseases?

PCORnet® Study of Post-Acute Sequelae of SARS-CoV-2 Infection in Adults (PCORnetPASC)

Study Updated 03/28/2024

Study Website: RECOVERCOVID
ClinicalTrials.gov#: NCT05292274
Study Design: Retrospective Observational
PCORnet Infrastructure: Collaboration, CDM, Engagement, Single IRB
Principal Investigator: Rainu Kaushal
Site Name: Weill Cornell Medicine
PCORnet® Network Partner: INSIGHT
Funder: NIH
Funding Date: 2022
Study Duration: 2022 – 2025
Participating Clinical Research Networks: GPC, INSIGHT, OneFlorida+, PaTH, REACHnet, STAR
Therapeutic Area: Infectious Disease
Condition: COVID-19; SARS CoV 2 Infection
Population: 18 Years and older (Adult, Older Adult)
Status: Active, not recruiting

Research Question(s):

  1. What are the long term health effects of COVID-19 after a person has recovered from infection?
  2. How can we better detect, predict, and treat these health effects and prevent future infection?

Primary Publication(s):
Prevalence of Select New Symptoms and Conditions Among Persons Aged Younger Than 20 Years and 20 Years or Older at 31 to 150 Days After Testing Positive or Negative for SARS-CoV-2
Hernandez-Romieu AC, Carton TW, Saydah S, et al. Prevalence of select new symptoms and conditions among person aged younger than 20 years and 20 years or older at 31 to 150 days after testing positive or negative for SARS-CoV-2. JAMA Netw Open. 2022;5(2):e2147053.

ACTIV-6: COVID-19 Study of Repurposed Medications

Study Updated 03/28/2024

Study Website: The Activ-6 Study
ClinicalTrials.gov#: NCT04885530
Study Design: Interventional
PCORnet Infrastructure: Collaboration, Engagement, Single IRB
Principal Investigator: Adrian Hernandez
Site Name: Duke Clinical Research Institute
PCORnet® Network Partner: Coordinating Center
Funder: NIH
Funding Date: 2021
Study Duration: 2021 – 2024
Participating Clinical Research Networks: GPC, INSIGHT, OneFlorida+, PaTH, REACHnet, STAR
Therapeutic Area: Infectious Disease
Condition
: COVID-19
Population: 30 Years and older (Adult, Older Adult)
Status: Recruiting

Research Question(s):
Can repurposed medications reduce symptoms of non-hospitalized participants with mild to moderate COVID-19?

Primary Publication(s):
Effect of Ivermectin vs Placebo on Time to Sustained Recovery in Outpatients With Mild to Moderate COVID-19
Naggie S, Boulware DR, Lindsell CJ, et al. Effect of Ivermectin vs Placebo on Time to Sustained Recovery in Outpatients With Mild to Moderate COVID-19: A Randomized Clinical Trial. JAMA. 2022;328(16):1595–1603. doi:10.1001/jama.2022.18590

Effect of Fluvoxamine vs Placebo on Time to Sustained Recovery in Outpatients With Mild to Moderate COVID-19
McCarthy MW, Naggie S, Boulware DR, et al. Effect of Fluvoxamine vs Placebo on Time to Sustained Recovery in Outpatients With Mild to Moderate COVID-19: A Randomized Clinical Trial. JAMA. 2023;329(4):296–305. doi:10.1001/jama.2022.24100

Medications and Weight Gain in PCORnet: The MedWeight Study

Study Updated 03/28/2024

Study Website: Medications and Weight Gain in PCORnet: The MedWeight Study
Study Design: Prospective Observational
PCORnet Infrastructure: Collaboration, CDM, Engagement, Single IRB
Principal Investigator: Jason Block
Site Name: Harvard Pilgrim Healthcare Institute
PCORnet® Network Partner: Legacy PCORnet Partner
Funder: NIH
Funding Date: 2020
Study Duration: 2020 – 2024
Participating Clinical Research Networks: GPC, OneFlorida+, PEDSnet, STAR
Therapeutic Area: Metabolic Disorders
Condition: Obesity; Diabetes
Population: Children 5 to 19 Years and Adults 20+ Years (Child, Adult)
Status: Completed

Research Question(s):
How do six classes of commonly prescribed medications influence weight, risk for diabetes, and cholesterol over time?

Pragmatic Evaluation of Events and Benefits of Lipid-lowering in Older Adults (PREVENTABLE)

Study Updated 03/28/2024

Study Website: PREVENTABLE
ClinicalTrials.gov#: NCT04262206
Study Design: Interventional
PCORnet Infrastructure: Collaboration, CDM (+ supplemental data), Engagement, Single IRB
Principal Investigator: Karen Alexander
Site Name: Duke Clinical Research Institute
PCORnet® Network Partner: Coordinating Center
Funder: NIH; (Project webpage)
Funding Date: 2019
Study Duration: 2020 – 2026
Participating Clinical Research Networks: GPC, INSIGHT, OneFlorida+, PaTH, REACHnet, STAR
Therapeutic Area: Cardiovascular
Condition: Cognitive Impairment, Mild; Dementia; Cardiovascular Diseases
Population: 75 Years and older (Older Adult)
Status: Recruiting

Research Question(s):
Can a statin help prevent dementia and disability in adults aged 75 or older, as well as heart attacks and other cardiovascular-related deaths, while not increasing risks of adverse health outcomes?

Primary Publication(s):
The PRagmatic EValuation of evENTs And Benefits of Lipid-lowering in oldEr adults (PREVENTABLE) trial: Study design and procedures for cognitive assessment and adjudication
Sachs BC, Rapp SR, Kistler CE, et al. The pragmatic evaluation of events and benefits of lipid-lowering in older adults (PREVENTABLE) trial: study design and procedures for cognitive assessment and adjudication. Alzherimers. Dement., 2021; 17(Supp.9).