Data Analysis for Drug Repurposing for Effective Alzheimer's Medicines (DREAM) - Salbutamol vs Long-acting Muscarinic Antagonists

NCT05457868 | Completed FDA Drug

• 1 other identifier: 2019A010961-9
• Study Type: observational
• Target: 124,117
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

• 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 120 days)

Secondary Outcomes (1)

• Time to Alzheimer's disease onset

  Through study completion (a median of 120 days)

Study Arms (2)

Salbutamol

Exposure group

Drug: Salbutamol

Long-acting muscarinic antagonists (LAMA)

Reference group

Drug: LAMA

Interventions

Salbutamol DRUG

Salbutamol claim is used as the exposure group.

Salbutamol

LAMA DRUG

Long-acting muscarinic antagonists (LAMA) - umeclidinium, aclidinium, tiotropium, glycopyrolate, glycopyrronium - claim is used as the reference group.

Long-acting muscarinic antagonists (LAMA)

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study will employ a new user, active comparator, observational cohort study design comparing Salbutamol versus Long-acting muscarinic antagonists (LAMAs). The patients will be required to have continuous enrollment during the baseline period of 365 days before initiation of study drugs (cohort entry/index date). Follow-up for the outcome (dementia) differs between analyses. Follow-up begins the day after drug initiation (analysis 1, 3, 4); 180 days after drug initiation (analysis 2).

You may qualify if:

• \. Aged \>/= 65 years on the index date
• \. No prior use of Salbutamol and Long-acting Muscarinic Antagonists (LAMA) anytime prior to cohort entry date
• \. Enrollment in Medicare Part A, B, and D with no HMO coverage for 365 days prior to and including cohort entry date
• \. At least two claims with COPD diagnosis measured 365 days prior to drug initiation

You may not qualify if:

• \. Prior history of dementia measured anytime prior to cohort entry date
• \. Prior history of nursing home admission in the 365 days prior to the cohort entry date

Sponsors & Collaborators

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

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02120, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Albuterol

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines

Study Officials

• Madhav Thambisetty, MD, PhD

  National Institute on Aging (NIA)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: July 11, 2022
• First Posted: July 14, 2022
• Study Start: February 1, 2021
• Primary Completion: July 30, 2022
• Study Completion: December 31, 2023
• Last Updated: July 28, 2025

Record last verified: 2025-07

Locations

US (1)