The Dallas Asthma Brain and Cognition (ABC) Study

Status:	Recruiting
Conditions:	Asthma
Therapuetic Areas:	Pulmonary / Respiratory Diseases
Healthy:	No
Age Range:	40 - 69
Updated:	3/15/2019
Start Date:	February 21, 2019
End Date:	January 2023
Contact:	Collette B. Bice, M.S.
Email:	collette.bice@utsouthwestern.edu
Phone:	214-645-6954

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.

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.

Inclusion Criteria:

- For asthma patients: diagnosis of asthma (verified by a medical documentation) for at
least 2 years; for healthy volunteers: no significant medical or psychiatric history.

- Ages 40 to 69 years old.

- Proficient in English.

- Education level of at least 10th grade level.

Exclusion Criteria:

- Treatment with oral corticosteroids in the previous 6 weeks, because of the potent
effects of this drug on airway reactivity.

- Spirometry: Forced Expiratory Volume (FEV1) below 60% of predicted.

- Diagnosis of vocal cord dysfunction (identified by abnormalities in spirometric
flow-volume curves), clinically significant chronic obstructive pulmonary disease, or
emphysema.

- Presence or history of medical or neurological disorder that may affect brain function
and the physiological systems of interest (e.g. angina, myocardial infarction,
congestive heart failure, transient ischemic attacks, cerebrovascular accidents,
diabetes mellitus, emphysema, or chronic obstructive pulmonary disease, history of
seizures or head trauma, endocrine disorders or renal disease, chemotherapy, presently
or in the past 5 years, uncontrolled diabetes, cholesterol greater than or equal to
200 (self-reported), blood pressure above 160/90 (self-reported or measured at session
1).

- Corrected vision poorer than 20/30 on Snellen Eye Chart.

- Presence or history of Schizophrenia, Psychosis, or Dementia.

- Current or recent history (within 1 year) of Substance Related Disorders, current
recreational drug use or consuming more than 20 alcoholic drinks per week.

- Current treatment with anti-psychotics, sedatives, benzodiazepines with a half-life
longer than 6 hours.

- Previous electroconvulsive therapy.

- Presence of history of orthopaedic circumstances and metallic inserts interfering with
MR scanning (prior surgeries and/or implant pacemakers, pacemaker wires, artificial
heart value, brain aneurysm surgery, middle ear implant, non-removable hearing aid or
jewelry, braces or extensive dental work, cataract surgery or lens implant, implanted
mechanical or electrical device, artificial limb or joint, foreign metallic objects in
the body such as bullets, BB's, shrapnel, or metalwork fragments, pregnancy,
claustrophobia, uncontrollable shaking, or inability to lie still for one hour.

- Not proficient in English.

- In the opinion of the principal investigator, participant is otherwise unsuitable for
this study.

We found this trial at

sites

University of Texas Southwestern Medical Center

1801 Inwood Rd
Dallas, Texas 75390

(214) 645-3300