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| ID | Type | Description | Link |
|---|---|---|---|
| R44AG071388 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Columbia University | OTHER |
| National Institute on Aging (NIA) | NIH |
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This study is a phase 2a randomized double-blind, placebo-controlled, study, in mild-to-moderate Alzheimer's disease, of the oral investigational drug MW150, a p38alphaMAPK kinase inhibitor. The primary goals of this study are to investigate the safety and tolerability, and drug movements in the body. The secondary goals of the study are to investigate the effects of the drug on cognitive performance, activities of daily living, and behavior, and the biological effects of the drug on blood biomarkers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 10mg MW150 daily | Experimental | 10 mg MW150 daily (1 capsule of 10 mg daily) |
|
| placebo daily | Placebo Comparator | placebo daily (1 capsule of matched placebo daily) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MW150 | Drug | oral-delivered capsule of study drug |
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| Measure | Description | Time Frame |
|---|---|---|
| Drug Safety- Blood tests | Number of participants with treatment-related adverse events as assessed by laboratory test abnormalities. | 84 days treatment |
| Drug Safety- Electrocardiographic | Number of participants with emergent abnormal electrocardiograms. | 84 days treatment |
| Drug Safety- C-SSRS | Development of any suicidality on COLUMBIA-SUICIDE SEVERITY RATING SCALE (C-SSRS) score (minimum 0, no maximum, higher number worse). | 84 days treatment |
| Drug Tolerability- Adverse events | Incidence of adverse events (AE). | 84 days treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Cognitive change-MMSE | Change in MiniMental State Examination (MMSE) score (0-30, higher score better). | 84 days treatment |
| Cognitive change-ADAScog | Change in Alzheimer's Disease Assessment Scale (ADAScog) score (0-70, higher score worse). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lawrence S Honig, MD PhD | Contact | 2123059194 | lh456@cumc.columbia.edu | |
| Wayne P Anderson, PhD | Contact | nkt.wanderson@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Lawrence S Honig, MD PhD | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University Irving Medical Center | New York | New York | 10032 | United States |
Once study complete, de-identified participant data will be shared upon request by investigators from an academic institution.
ICF will be shared at onset of enrollment. Study Protocol and SAP will be shared once study published. CSR will be shared once completed.
Protocol, SAP will be shared via publication. CSR will be shared upon request
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D003704 | Dementia |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
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| ID | Term |
|---|---|
| C000634366 | MW01-18-150SRM |
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double-blind randomized placebo-controlled
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Subjects will be randomized through a computerized system by a Data/Statistics Group independent from the investigator or Sponsor
| Placebo | Drug | oral delivered capsule matched to study drug capsule |
|
| 84 days treatment |
| Cognitive change-Executive | Change in Trails A (0 - 150 sec) and Trails B test scores (0-300 sec), higher scores worse. | 84 days treatment |
| Cognitive change-Language | Change in Verbal Fluency tests for animals and letters (both minimum 0, no maximum, higher scores better). | 84 days treatment |
| Functional performance- ADCS-ADL | Change in Alzheimers Disease Cooperative Study Activities of Daily Living (ADCS-ADL) scale (0 - 78, higher score better). | 84 days treatment |
| Functional performance-CDR | Change in Clinical Disease Rating Scale (0 - 3, higher score worse). | 84 days treatment |
| Behavioral Scale - NPI-Q | Change in Neuropsychiatric Inventory Questionnaire (NPI-Q) (0-36, higher scores worse). | 84 days treatment |
| Pharmacodynamics - cytokines | Changes in biomarker measurements of plasma levels of cytokines (IFN-γ, IL-1β, IL-4, IL-5, IL-6, IL-8, IL-10, IL-12P70, IL-22, and TNFα) by Simoa assay (pg/mL). | 84 days treatment |
| Pharmacodynamics - neuronal biomarkers | Changes in biomarker measurements of plasma levels of tau protein and NfL protein by Simoa assay (pg/mL). | 84 days treatment |
| D019636 |
| Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |