Adenosine 2A Receptor Antagonism and AIH in ALS

Description

The purpose of this research study is to determine the effects of a medication, istradefylline, in conjunction with breathing air with reduced oxygen for short periods of time (called acute intermittent hypoxia, or AIH), on breathing. This project will study breathing in people with amyotrophic lateral sclerosis (ALS) and unaffected, age-matched adults. Istradefylline is prescribed to increase movement in people with other neuromuscular conditions. A recently completed study found that people with ALS took deeper breaths, 60 minutes after using AIH.

Conditions

ALS

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Study Overview

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Study Details

Study overview

The purpose of this research study is to determine the effects of a medication, istradefylline, in conjunction with breathing air with reduced oxygen for short periods of time (called acute intermittent hypoxia, or AIH), on breathing. This project will study breathing in people with amyotrophic lateral sclerosis (ALS) and unaffected, age-matched adults. Istradefylline is prescribed to increase movement in people with other neuromuscular conditions. A recently completed study found that people with ALS took deeper breaths, 60 minutes after using AIH.

Acute Adenosine Receptor Antagonism to Promote Breathing Plasticity in ALS

Adenosine 2A Receptor Antagonism and AIH in ALS

Condition
ALS
Intervention / Treatment

-

Contacts and Locations

Gainesville

Clinical and Translational Research Building, Gainesville, Florida, United States, 32610

Jacksonville

UF Health Jacksonville, Jacksonville, Florida, United States, 32209

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Non-smoking adults aged 21-80 years will be eligible to participate.
  • 2. ALS diagnosis (El Escorial diagnostic classifications of probable/definite ALS),
  • 3. vital capacity (VC) \> 60% of predicted value, and
  • 4. ALS Functional Rating Scale (ALSFRS-R) scores of 2 or greater for bulbar and respiratory items: swallowing, speech, salivation, dyspnea, orthopnea, and respiratory insufficiency.
  • 5. Additionally, patients taking riluzole and/or edaravone must be on a stable dose for \>30 days.
  • 6. Unaffected control subjects will be eligible if they have a vital capacity (VC) \> 60% of predicted value.
  • 1. are pregnant
  • 2. have an active respiratory infection,
  • 3. took antibiotics within 4 weeks,
  • 4. are diagnosed with another neurodegenerative disease,
  • 5. have symptomatic cardiovascular disease or dysrhythmias (resting tachycardia and hypertension),
  • 6. exhibit history or presence of hypoxemia or hypercapnia,
  • 7. presence of rest tachypnea (RR ˃30),
  • 8. have a BMI \>35 kg/m2,
  • 9. have a seizure disorder,
  • 10. take respiratory inhalers daily for airway disease, or
  • 11. require external respiratory support while awake and upright, or
  • 12. supplemental oxygen at rest or at night.
  • 13. In addition, the following conditions are exclusionary for the use of istradefylline: routine use of CYP3A4 inducers (i.e. carbamazepine, phenobarbitol, rifampin, phenytoin, St. John's Wort, glucocorticoids) or
  • 14. medications that may suppress ventilation, history of moderate renal impairment or severe hepatic impairment, and history of hallucinations or psychosis.
  • 15. Patients who cannot safety swallow thin liquids (required for administration of istradefylline and placebo) will also be ineligible.

Ages Eligible for Study

21 Years to 80 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

University of Florida,

Barbara Smith, PRINCIPAL_INVESTIGATOR, University of Florida

Study Record Dates

2025-12-31