MW150 Stress Kinase Inhibitor in Mild to Moderate Alzheimer's Disease

NCT05194163 | Unknown Phase 2 DMC FDA Drug

• 2 other identifiers: MW150-AD-201R44AG071388
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Alzheimer Disease

Keywords

p38alphaMAPK; dementia

Outcome Measures

Primary Outcomes (4)

• 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

Secondary Outcomes (9)

• Cognitive change-MMSE

  84 days treatment

• Cognitive change-ADAScog

  84 days treatment

• Cognitive change-Executive

  84 days treatment

• Cognitive change-Language

  84 days treatment

• Functional performance- ADCS-ADL

  84 days treatment

Study Arms (2)

10mg MW150 daily

EXPERIMENTAL

10 mg MW150 daily (1 capsule of 10 mg daily)

Drug: MW150

placebo daily

PLACEBO COMPARATOR

placebo daily (1 capsule of matched placebo daily)

Drug: Placebo

Interventions

MW150 DRUG

oral-delivered capsule of study drug

Also known as: MW01-18-150SRM

10mg MW150 daily

Placebo DRUG

oral delivered capsule matched to study drug capsule

placebo daily

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent from subject (or legally authorized representative, LAR) and study partner.
• Male or female, age 50 to 90 inclusive.
• Have a study partner who is able to accompany the subject, has frequent contact with subject.
• Meet criteria for Alzheimer's Disease by NIAA-AA criteria.
• Must speak English fluently.
• Must have education of at least 8 years.
• Must have adequate hearing and visual abilities.
• MMSE score of 14 to 28.
• Clinical Dementia Rating (CDR) Global score of 0.5 to 2.0 inclusive.
• Absence of suicidal ideation for at least 1 year.
• Absence of medical conditions that could affect ability to participate in study.
• MRI within 1 year of screening, not showing clinically significant structural lesions. Subjects without available MRI within 1 year, must have an MRI performed for eligibility.
• Stable neuropsychiatric medications for at least 2 months prior to screening.
• If female, must not be of childbearing potential, as defined by being postmenopausal (more than 1 year without periods) or surgically sterile for at least 6 months prior to screening.
• If male, must agree to use contraception if with a potentially childbearing partner.

You may not qualify if:

• Presence of clinically significant disorders of the central nervous system other than Alzheimer's disease, such as Lewy Body Disease, Parkinson's disease, hydrocephalus, epilepsy, demyelinating disease, brain tumors, or psychiatric disorders (such as schizophrenia, or severe affective disorders).
• Serious or unstable hematologic, hepatic, renal, pulmonary, cardiac, or other medical disease.
• Abnormal liver function tests (ALT or AST) or creatine kinase (CK) upon repeat testing.
• Chronic hepatitis B or C infection, indicated by positive HBSAg, or HCV-Ab with HCV RNA presence.
• Known history of human immunodeficiency virus (HIV) infection.
• Known immune disorder that has a history of requiring treatment with immunosuppressive drugs within the past 1 year.
• Have a drug or alcohol abuse within 12 months prior to screening.
• Clinically significant laboratory abnormalities at screening.
• Screening ECG showing repeated QTcF \> 480 msec, or other clinically significant ECG abnormalities.
• Clinically significant structural brain abnormalities, such as hydrocephalus or intra-axial brain tumors.
• Participation in another investigational study within 30 days or 5 half-lives prior to screening, whichever is greater.
• Participation in another study that would have cognitive testing during the duration of this study.
• History of Covid19 or other viral infections within 3 months.
• Have a clinically significant medical, surgical, laboratory, or behavioral abnormality, which in the judgment of the Investigator makes the subject unsuitable for the study.

Sponsors & Collaborators

• Neurokine Therapeutics: lead
• Columbia University: collaborator
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Alzheimer Disease; Dementia

Interventions

MW01-18-150SRM

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Lawrence S Honig, MD PhD

  Columbia University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lawrence S Honig, MD PhD

CONTACT

2123059194; lh456@cumc.columbia.edu

Wayne P Anderson, PhD

CONTACT

nkt.wanderson@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Subjects will be randomized through a computerized system by a Data/Statistics Group independent from the investigator or Sponsor
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Neurology at Columbia University Irving Medical Center

Model Details: double-blind randomized placebo-controlled

Study Record Dates

• First Submitted: January 13, 2022
• First Posted: January 18, 2022
• Study Start: May 1, 2022
• Primary Completion: August 31, 2024
• Study Completion: November 30, 2024
• Last Updated: March 29, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: ICF will be shared at onset of enrollment. Study Protocol and SAP will be shared once study published. CSR will be shared once completed.
• Access Criteria: Protocol, SAP will be shared via publication. CSR will be shared upon request

Locations

US (1)