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Montelukast Therapy for Alzheimer's Disease

Start: September 25, 2019
End: June 2022
Enrollment: 150

What Is This Study About?

This clinical trial will test montelukast, a medication used to treat asthma, on the memory and thinking in people with mild cognitive impairment and early Alzheimer's dementia. 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 one year. Researchers will look at brain imaging, cognitive function, and biomarkers from a lumbar puncture to measure the effect.

Do I Qualify To Participate in This Study?

Minimum Age: 50 Years

Maximum Age: N/A

Must have:

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

Must NOT have:

  • 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 three 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
 

Study Contact
Ihab Hajjar, MD
4047121763
ihajjar@emory.edu

Need Help?

Contact NIA’s Alzheimer’s and related Dementias Education and Referral (ADEAR) Center at 800-438-4380 or email ADEAR.

Where Is This Study Located?

Georgia
Emory Clinic
Atlanta, GA 30322
Recruiting
Ihab Hajjar, MD
404-712-1763
ihajjar@emory.edu
Emory University Hospital Clinical Research Network
Atlanta, GA 30322
Recruiting
Ihab Hajjar, MD
404-712-1763
ihajjar@emory.edu
Executive Park
Atlanta, GA 30329
Recruiting
Ihab Hajjar, MD
404-712-1763
ihajjar@emory.edu
Wesley Woods
Atlanta, GA 30329
Recruiting
Ihab Hajjar, MD
404-712-1763
ihajjar@emory.edu

Who Sponsors This Study?

Lead: Emory University

Source: ClinicalTrials.gov ID: NCT03991988