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

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05457855
• Other study ID #: 2019P003607-10
• Status: Active, not recruiting
• Start date: February 1, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: July 2023
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 75678
• Est. completion date: December 31, 2023
• Est. primary completion date: July 7, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

Please see https://docs.google.com/spreadsheets/d/1u8YFpnMHI5HprhyuY14tIgd1COZcsAWKFlbYCT7aL_A/edit?us p=sharing or Appendix A (https://drive.google.com/file/d/1uC_G8TJ1ujoJbas1p1gFaYFzY7Hw7xMq/view?usp=sharing) 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

• 2. No prior use of Montelukast and Fluticasone anytime prior to cohort entry date

• 3. Enrollment in Medicare Part A, B, and D with no HMO coverage for 365 days prior to and including cohort entry date

• 4. 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

• 2. Prior history of nursing home admission in the 365 days prior to the cohort entry date

Related Conditions & MeSH terms

• Asthma

Intervention

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

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (4)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	Johns Hopkins University, National Institute on Aging (NIA), Rutgers University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to dementia onset	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.	Through study completion (a median of 144 days)
Secondary	Time to Alzheimer's disease onset	Time to Alzheimer's disease onset. Please refer to uploaded protocol for full definition due to size limitations.	Through study completion (a median of 144 days)