Last reviewed · How we verify
Montelukast Therapy on Alzheimer's Disease
Phase 2 trial testing Montelukast in Alzheimer Disease in 32 participants. Completed in 18 November 2022.
| Lead sponsor | Emory University |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 32 |
| Start date | 25 September 2019 |
| Primary completion | 18 November 2022 |
| Estimated completion | 18 November 2022 |
| Sites | 4 locations across United States |
Emory University
50 and older, any sex, with Alzheimer Disease. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of participants with any GI symptoms reported: diarrhea, nausea, vomiting
| Group | Value | 95% CI |
|---|---|---|
| Montelukast Group | 1 | |
| Placebo Group | 1 |
Number of participants with reported anaphylaxis during follow up time
| Group | Value | 95% CI |
|---|---|---|
| Montelukast Group | 1 | |
| Placebo Group | 0 |
Number of participants with elevated liver enzymes during follow up
| Group | Value | 95% CI |
|---|---|---|
| Montelukast Group | 0 | |
| Placebo Group | 0 |
Prothrombin time (PT)/ international normalized ratio (INR) will be measured at baseline and 1 year.
| Group | Value | 95% CI |
|---|---|---|
| Montelukast Group | 1.05 | ± 0.02 |
| Placebo Group | 1.02 | ± 0.01 |
| Group | Value | 95% CI |
|---|---|---|
| Placebo Group | 1.05 | ± 0.05 |
The NPI-Q is designed to be a self-administered questionnaire completed by informants about patients for whom they care. Each of the 12 NPI-Q domains contains a survey question that reflects cardinal symptoms of that domain. Initial responses to each domain question are "Yes" (present) or "No" (absent). If the response to the domain question is "No", the informant goes to the next question. If "Yes", the informant then rates both the Severity of the symptoms present within the last month on a 3-point scale and the associated impact of the symptom manifestations on them (i.e. Caregiver Distress
| Group | Value | 95% CI |
|---|---|---|
| Montelukast Group | 5.00 | ± 0.97 |
| Placebo Group | 2.62 | ± 0.95 |
| Group | Value | 95% CI |
|---|---|---|
| Montelukast Group | 5.68 | ± 1.04 |
| Placebo Group | 2.73 | ± 1.02 |
Number of participants that reported seizures during follow up time
| Group | Value | 95% CI |
|---|---|---|
| Montelukast Group | 0 | |
| Placebo Group | 0 |
Number of participants that stopped taking Montelukast during follow up time
| Group | Value | 95% CI |
|---|---|---|
| Montelukast Group | 0 | |
| Placebo Group | 0 |
A lumbar puncture will be done at baseline and at 12 months follow up Approximately 30-45 ml of CSF will be collected using sterile polypropylene collection tubes. Amyloid-β42 is reported as pg/ml.
| Group | Value | 95% CI |
|---|---|---|
| Montelukast Group | 849.4 | ± 77.34 |
| Placebo Group | 704.6 | ± 89.48 |
| Group | Value | 95% CI |
|---|---|---|
| Montelukast Group | 795.5 | ± 76.60 |
| Placebo Group | 695.2 | ± 88.11 |
CSF tau protein (CSF-tau) is found in most patients with Alzheimer's disease. A lumbar puncture will be done at baseline and at 12 months follow up. Approximately 30-45 ml of CSF will be collected using sterile polypropylene collection tubes. Results will be reported as Phospho tau (p-tau181) in pg/ml.
| Group | Value | 95% CI |
|---|---|---|
| Montelukast Group | 20.6 | ± 2.42 |
| Placebo Group | 22.8 | ± 2.81 |
| Group | Value | 95% CI |
|---|---|---|
| Montelukast Group | 21.1 | ± 2.48 |
| Placebo Group | 21.9 | ± 2.86 |
The CDR rates each of the six general domains (or boxes) involving memory, orientation, judgment and problem-solving, community affairs, home and hobbies, and personal care, and a global rating is then generated, ranging from 0 to 3. A score of 0 = normal, 0.5 = very mild dementia, 1 = mild dementia, 2 = moderate dementia, and 3 = severe dementia.
| Group | Value | 95% CI |
|---|---|---|
| Montelukast Group | 0.6 | ± 0.05 |
| Placebo Group | 0.6 | ± 0.04 |
| Group | Value | 95% CI |
|---|---|---|
| Montelukast Group | 0.7 | ± 0.07 |
| Placebo Group | 0.7 | ± 0.07 |
The NIH Toolbox® is a computer-based comprehensive set of neuro-behavioral measurements that reliably and validly assesses neurocognitive sub-domains in clinical trials, including working memory, episodic memory, processing speed, language, attention and executive function. The fluid cognitive composite (FCC) score is derived by averaging the standard scores of each of the fluid tests (Picture Sequence Memory, List Sorting, Pattern Comparison, Flanker, and Dimensional Change Card Sort.), and then deriving standard scores based on this new distribution. The fully-adjusted FCC T-score is reporte
| Group | Value | 95% CI |
|---|---|---|
| Montelukast Group | 35.2 | ± 2.53 |
| Placebo Group | 35.4 | ± 2.93 |
| Group | Value | 95% CI |
|---|---|---|
| Montelukast Group | 33.9 | ± 2.89 |
| Placebo Group | 37.3 | ± 3.41 |
Time frame: During follow up time, an average of 1 year. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Montelukast Group | Placebo Group |
|---|---|---|---|
| Nausea | Gastrointestinal disorders | — | — |
| Vomiting | Gastrointestinal disorders | — | — |
| Rash | General disorders | — | — |
| Dizziness | General disorders | — | — |
| Headache | General disorders | — | — |
| Fatigue | General disorders | — | — |
| Low Mood | General disorders | — | — |
Data from ClinicalTrials.gov NCT03991988 adverse events section.
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.
8 peer-reviewed publications reference this trial (live from Europe PMC):
Verify or expand the search:
Trials testing the same drug.
Currently open trials in the same condition.
Trials by the same sponsor.
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03991988.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing