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Data Analysis for Drug Repurposing for Effective Alzheimer's Medicines (DREAM) - Montelukast vs Fluticasone

Sponsor
Brigham and Women's Hospital (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05457855
Collaborator
National Institute on Aging (NIA) (NIH), Rutgers University (Other), Johns Hopkins University (Other)
75,678
Enrollment
1
Location
11.9
Anticipated Duration (Months)
6345.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study aims to evaluate the comparative risk of dementia/Alzheimer's disease onset between patients treated with medications that target specific metabolic pathways and patients treated with alternative medications for the same indication.

Condition or Disease Intervention/Treatment Phase

Detailed Description

This is a non-randomized, non-interventional study that is part of the DREAM Study of Brigham and Women's Hospital. DREAM is led by Dr. Madhav Thambisetty, MD, PhD, Chief of the Clinical and Translational Neuroscience Section, Laboratory of Behavioral Neuroscience, National Institute on Aging (NIA) intramural research program. This study aims to evaluate the comparative risk of dementia/Alzheimer's disease onset between patients treated with medications that target specific metabolic pathways and patients treated with alternative medications for the same indication using healthcare claims data.

Study Design

Study Type:
Observational
Actual Enrollment :
75678 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Data Analysis for Drug Repurposing for Effective Alzheimer's Medicines (DREAM) - Montelukast vs Fluticasone
Actual Study Start Date :
Feb 1, 2022
Anticipated Primary Completion Date :
Jul 30, 2022
Anticipated Study Completion Date :
Jan 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Montelukast

Exposure group

Drug: Montelukast
Montelukast claim is used as the exposure group.
Fluticasone

Reference group

Drug: Fluticasone
Fluticasone claim is used as the reference group.

Outcome Measures

Primary Outcome Measures

  1. Time to dementia onset [Through study completion (a median of 144 days)]

    Time to dementia onset, i.e., Alzheimer's disease, vascular dementia, senile, presenile, or unspecified dementia, or dementia in other diseases classified elsewhere. Please refer to uploaded protocol for full definition due to size limitations.

Secondary Outcome Measures

  1. Time to Alzheimer's disease onset [Through study completion (a median of 144 days)]

    Time to Alzheimer's disease onset. Please refer to uploaded protocol for full definition due to size limitations.

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes

Please see https://docs.google.com/spreadsheets/d/1u8YFpnMHI5HprhyuY14tIgd1COZcsAWKFlbYCT7aL_A/edit?us p=sharing or Appendix A for full code and algorithm definitions.

Medicare timeframe: 2008 to 2018 (end of data availability).

Inclusion Criteria:
    1. Aged >/= 65 years on the index date
    1. No prior use of Montelukast and Fluticasone anytime prior to cohort entry date
    1. Enrollment in Medicare Part A, B, and D with no HMO coverage for 365 days prior to and including cohort entry date
    1. At least two claims with asthma diagnosis measured 365 days prior to drug init
Exclusion Criteria:
    1. Prior history of dementia measured anytime prior to cohort entry date
    1. Prior history of nursing home admission in the 365 days prior to the cohort entry date

Contacts and Locations

Locations

Site City State Country Postal Code
1 Brigham and Women's Hospital Boston Massachusetts United States 02120

Sponsors and Collaborators

  • Brigham and Women's Hospital
  • National Institute on Aging (NIA)
  • Rutgers University
  • Johns Hopkins University

Investigators

  • Principal Investigator: Madhav Thambisetty, MD, PhD, National Institute on Aging (NIA)

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Rishi J. Desai, Assistant Professor of Medicine, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT05457855
Other Study ID Numbers:
  • 2019A010961-10
First Posted:
Jul 14, 2022
Last Update Posted:
Jul 14, 2022
Last Verified:
Jul 1, 2022
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Fluticasone
Montelukast

Study Results

No Results Posted as of Jul 14, 2022