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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
24
Columbia University Irving Medical Center
New York, New York, United States
Drug Safety- Blood tests
Number of participants with treatment-related adverse events as assessed by laboratory test abnormalities.
Time frame: 84 days treatment
Drug Safety- Electrocardiographic
Number of participants with emergent abnormal electrocardiograms.
Time frame: 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).
Time frame: 84 days treatment
Drug Tolerability- Adverse events
Incidence of adverse events (AE).
Time frame: 84 days treatment
Cognitive change-MMSE
Change in MiniMental State Examination (MMSE) score (0-30, higher score better).
Time frame: 84 days treatment
Cognitive change-ADAScog
Change in Alzheimer's Disease Assessment Scale (ADAScog) score (0-70, higher score worse).
Time frame: 84 days treatment
Cognitive change-Executive
Change in Trails A (0 - 150 sec) and Trails B test scores (0-300 sec), higher scores worse.
Time frame: 84 days treatment
Cognitive change-Language
Change in Verbal Fluency tests for animals and letters (both minimum 0, no maximum, higher scores better).
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Time frame: 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).
Time frame: 84 days treatment
Functional performance-CDR
Change in Clinical Disease Rating Scale (0 - 3, higher score worse).
Time frame: 84 days treatment
Behavioral Scale - NPI-Q
Change in Neuropsychiatric Inventory Questionnaire (NPI-Q) (0-36, higher scores worse).
Time frame: 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).
Time frame: 84 days treatment
Pharmacodynamics - neuronal biomarkers
Changes in biomarker measurements of plasma levels of tau protein and NfL protein by Simoa assay (pg/mL).
Time frame: 84 days treatment