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Montelukast Therapy for Alzheimer's Disease

Recruiting

This clinical trial will test montelukast, drug used to treat asthma, breathing difficulties during exercise, and allergic rhinitis, in people with mild cognitive impairment and early Alzheimer's dementia. Researchers will look for adverse effects as well as changes in memory and other cognitive functions and Alzheimer's biomarkers.

Minimum Age Maximum Age Gender Healthy Volunteers
50 Years N/A All No
September 25, 2019
August 2021
150

  • Subjective memory concern or abnormal memory function, as documented by test results

  • Intolerance to montelukast
  • Current diagnosis of bronchial asthma or exercise-induced bronchospasm and currently taking montelukast or other leukotriene receptor antagonists (Zafirlukast, Pranlukast)
  • Liver disease (elevated liver enzymes >2x normal)
  • Renal disease (creatinine >2 mg/dl)
  • Diagnosis of any neurological or psychiatric disorder that affects cognition, such as uncontrolled depression, schizophrenia, Parkinson's disease, or multiple sclerosis
  • Other contributing factors to cognitive impairment, such as uncontrolled hypothyroidism or untreated low vitamin B12
  • Uncontrolled congestive heart failure, reflected by poor exercise tolerance and shortness of breath at rest or with some exertion
  • Actively undergoing chemotherapy or radiation therapy for cancer treatment
  • History of stroke in the past 3 years
  • Severely impaired cognition
  • Inability to have MRI and lumbar puncture (e.g., metal implants or cardiac pacemaker, bleeding diathesis)
  • Hearing, vision, or language issues or severe impairment that preclude cognitive assessment
  • History of increased intracranial pressure
  • Use of phenobarbital or rifampin due to drug interaction

Participants will be randomly assigned to take either the study drug or a placebo, starting at 10 mg daily and rising to 20 mg and 40 mg, for 1 year. They will also undergo lumbar puncture and brain imaging to assess changes in Alzheimer's biomarkers.

Montelukast is in a class of medications called leukotriene receptor antagonists (LTRAs). Past studies have shown it has a positive effect against inflammatory processes in the brain and on neuronal injury, blood-brain-barrier integrity, and beta-amyloid-42 accumulation. But its effects on memory and thinking abilities and on Alzheimer's biomarkers are yet to be fully understood.

Name City State Zip Status Primary Contact
Emory Clinic
Atlanta Georgia 30322 Recruiting Ihab Hajjar, MD
404-712-1763
ihajjar@emory.edu
Emory University Hospital Clinical Research Network
Atlanta Georgia 30322 Recruiting Ihab Hajjar, MD
404-712-1763
ihajjar@emory.edu
Executive Park
Atlanta Georgia 30329 Recruiting Ihab Hajjar, MD
404-712-1763
ihajjar@emory.edu
Wesley Woods
Atlanta Georgia 30329 Recruiting Ihab Hajjar, MD
404-712-1763
ihajjar@emory.edu

Emory University

Name Role Affiliation
Ihab Hajjar Principal Investigator Emory University

Name Phone Email
Ihab Hajjar, MD 4047121763 ihajjar@emory.edu

NCT03991988

Effects of Montelukast Therapy on Alzheimer's Disease (EMERALD)