NCT03794856

The Dallas Asthma Brain and Cognition (ABC) Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 130 (actual)
• Sponsor: University of Texas Southwestern Medical Center · Academic / Other
• Sex: All
• Age: 40 Years – 69 Years
• Healthy volunteers: Accepted

Summary

Asthma is a chronic inflammatory airway disease that leads to episodic symptom exacerbations, which exerts a substantial burden on quality of life and can influence other health domains if not adequately controlled. Asthma prevalence rates have increased in the past decade, affecting 8.4% (25.7 million people) of the United States population. The economic costs of asthma have been estimated annually with $56 billion in the US alone. Despite progress in pharmacological treatment, overall asthma control remains unsatisfactory and treatment non-adherence is extremely high. Asthma is particularly under diagnosed and understudied in aging adults. This problem will increase in coming decades given demographic trends and will disproportionally contribute to the societal and personal economic costs associated with asthma treatment and management. In the proposed 4-year project we will evaluate, in a two-session assessment recruiting a total of 126 asthma patients and 66 healthy controls aged 40-69 years, the extent to which asthma and aging are associated with changes in cognition and brain chemistry, structure, and function.

Detailed description

This study will implement a cross-sectional design, conducted across two sessions. The first session will capture cognitive performance, health history, and relevant social, behavioral, and emotional processes. The second session approximately one week later will capture neural structure, function, and chemistry. In the first session, participants will undergo screening for psychological disorders, neuropsychological testing and pulmonary function assessment at the Southern Methodist University (SMU) or UT Southwestern site. They will then participate in a second session at University of Texas Southwestern Medical Center (UTSW) Advanced Imaging Research Center (AIRC) with structural and functional magnetic resonance imaging (MRI), diffusion tensor imaging (DTI), and brain metabolic activity with spectroscopy. Blood draws and additional pre- and post-neuroimaging spirometry will also be performed at the second session. Potential participants identified by brief phone screen will be invited for two assessment sessions 1 week apart. At the first session, they will be consented, interviewed about their asthma and/or general health status, and pulmonary function tests will be performed. They will then fill in questionnaires and will be screened for psychological disorders by standardized psychiatric interview. After that, they will complete the neuropsychological test battery. The second session will entail spirometry (to ascertain adequate lung function for imaging), the 1 ½ hour neuroimaging protocol, saliva samples, and blood sampling. Spirometry will be repeated at the end of the imaging session. We will also offer patients a brief optional session before the imaging session to get acquainted to the scanning environment in a mock scanner.

Conditions

• Asthma

Interventions

Type	Name	Description
OTHER	Functional and Structural Magnetic Resonance Imaging (research grade)	Brain structure and function will be compared in middle to late-age adults with asthma compared to healthy adults.
OTHER	Cognitive Function Testing (non-diagnostic)	Multiple domains of cognitive functioning will be investigated, including processing speed, executive functioning/working memory and episodic memory.
OTHER	Asthma and Psychological Questionnaires (non-diagnostic)	Participants will fill out asthma and psychological questionnaires (non-diagnostic)

Timeline

• Start date: 2019-02-21
• Primary completion: 2025-05-28
• Completion: 2025-05-28
• First posted: 2019-01-07
• Last updated: 2025-07-09

Locations

2 sites across 1 country: United States