Phase 2 N=32 Randomized Double-blind Treatment

Montelukast Therapy on Alzheimer's Disease

Alzheimer Disease

Bottom Line

View on ClinicalTrials.gov: NCT03991988 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2024

Primary outcome: Primary: Number of Participants With Any Gastrointestinal (GI) Symptoms — 1; 1 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Montelukast (Drug); Placebo oral tablet (Drug)
Age: Adult, Older Adult · 50+ yrs
Sex: All
Sponsor: Emory University
Primary completion: Nov 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Any Gastrointestinal (GI) Symptoms	1; 1	—
PRIMARY Number of Participants With Reported Anaphylaxis	1; 0	—
PRIMARY Number of Participants With Elevated Liver Enzymes	0; 0	—
PRIMARY Prothrombin Time (PT)/ International Normalized Ratio (INR)	1.05; 1.02; 1.05	—
PRIMARY Neuropsychiatric Inventory Questionnaire (NPI-Q) Score	5.00; 2.62; 5.68; 2.73	—
PRIMARY Number of Patients With Seizures	0; 0	—
PRIMARY Number of Discontinuations From Montelukast	0; 0	—
SECONDARY CSF Amyloid	849.4; 704.6; 795.5; 695.2	—
SECONDARY CSF Tau Levels	20.6; 22.8; 21.1; 21.9	—
SECONDARY Clinical Dementia Rating (CDR) Score	0.6; 0.6; 0.7; 0.7	—
SECONDARY NIH Toolbox Cognition Battery (NIHTB-CB)	35.2; 35.4; 33.9; 37.3	—

Summary

This is a one-year, double-blind placebo-controlled randomized clinical trial that compares montelukast to placebo in individuals with mild cognitive impairment (MCI) and early Alzheimer's disease (AD) dementia. The measures include cognitive function, cerebrospinal fluid (CSF) biomarkers and neuroimaging (cerebral perfusion and markers of vascular brain damage). Participants will be treated with montelukast (escalating doses:10, 20 to 40 mg) or matched placebo.

Eligibility Criteria

Inclusion Criteria

Age: 50 years or older
MCI group will be defined based on:

(i) Subjective memory concern;

(ii) Abnormal memory function documented using the Logical Memory subscale (Delayed Paragraph Recall, Paragraph A only) from the Wechsler Memory Scale-Revised (the maximum score is 25): [ 2x normal): Alanine aminotransferase (ALT), AST, alkaline phosphatase, total bilirubin);

Renal disease (Creatinine >2.0 mg/dl), platelets 1.9;
Diagnosis of any neurological or psychiatric disorders that affects cognition such as uncontrolled depression, schizophrenia, Parkinson's disease or use of anti-Parkinsonian therapies (unless used for essential tremor), multiple sclerosis, or other active medical condition that in the judgment of the study physicians would affect the safety of the subject or scientific integrity of the study;
Other contributing factors to cognitive impairment such as uncontrolled hypothyroidism (TSH >10 mU/l) or untreated low vitamin B12 ( 5 or CDR >2);
Inability to have MRI and LP e.g. for MRI, metal implants or cardiac pacemaker or for LP, bleeding diathesis from disease states or from use of anticoagulants such as warfarin, heparin and related products, Rivaroxaban or Xarelto, Apixaban or Eliquis, Edoxaban or Savaysa, Dabigatran or Pradaxa. Subjects who can have either one lumbar puncture (LP) or MRI will be enrolled;
Inability to have cognitive assessment due to hearing, vision, or language issues or due to severe impairment;
History of increased intracranial pressure (ICP);
In those who are unable to demonstrate that they understood the details of the study using the University of California, San Diego Brief Assessment of Capacity to Consent (UBACC) instrument modified for EMERALD (i.e. lack of decisional-capacity to consent), a study partner/surrogate who can sign on their behalf will be required; otherwise, they will be excluded;
Use of phenobarbital or rifampin due to drug interaction.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03991988). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.