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

Alzheimer Disease Clinical Trial

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Official title:

A Phase 2a Study of MW150 Stress Kinase Inhibitor in Mild to Moderate Alzheimer's Disease

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05194163
• Other study ID #: MW150-AD-201
• Secondary ID: R44AG071388
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: May 1, 2022
• Est. completion date: November 30, 2024

Study information

• Verified date: March 2022
• Source: Neurokine Therapeutics
• Contact: Lawrence S Honig, MD PhD
• Phone: 2123059194
• Email: lh456[@]cumc.columbia.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 24
• Est. completion date: November 30, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 90 Years

Eligibility

Inclusion Criteria:

1. Signed informed consent from subject (or legally authorized representative, LAR) and study partner.

2. Male or female, age 50 to 90 inclusive.

3. Have a study partner who is able to accompany the subject, has frequent contact with subject.

4. Meet criteria for Alzheimer's Disease by NIAA-AA criteria.

5. Must speak English fluently.

6. Must have education of at least 8 years.

7. Must have adequate hearing and visual abilities.

8. MMSE score of 14 to 28.

9. Clinical Dementia Rating (CDR) Global score of 0.5 to 2.0 inclusive.

10. Absence of suicidal ideation for at least 1 year.

11. Absence of medical conditions that could affect ability to participate in study.

12. 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.

13. Stable neuropsychiatric medications for at least 2 months prior to screening.

14. 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.

15. If male, must agree to use contraception if with a potentially childbearing partner.

Exclusion Criteria:

1. 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).

2. Serious or unstable hematologic, hepatic, renal, pulmonary, cardiac, or other medical disease.

3. Abnormal liver function tests (ALT or AST) or creatine kinase (CK) upon repeat testing.

4. Chronic hepatitis B or C infection, indicated by positive HBSAg, or HCV-Ab with HCV RNA presence.

5. Known history of human immunodeficiency virus (HIV) infection.

6. Known immune disorder that has a history of requiring treatment with immunosuppressive drugs within the past 1 year.

7. Have a drug or alcohol abuse within 12 months prior to screening.

8. Clinically significant laboratory abnormalities at screening.

9. Screening ECG showing repeated QTcF > 480 msec, or other clinically significant ECG abnormalities.

10. Clinically significant structural brain abnormalities, such as hydrocephalus or intra-axial brain tumors.

11. Participation in another investigational study within 30 days or 5 half-lives prior to screening, whichever is greater.

12. Participation in another study that would have cognitive testing during the duration of this study.

13. History of Covid19 or other viral infections within 3 months.

14. Have a clinically significant medical, surgical, laboratory, or behavioral abnormality, which in the judgment of the Investigator makes the subject unsuitable for the study.

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

Drug:
• MW150
oral-delivered capsule of study drug
• Placebo
oral delivered capsule matched to study drug capsule

Locations

Country	Name	City	State
United States	Columbia University Irving Medical Center	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
Neurokine Therapeutics	Columbia University, National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Drug Safety- Blood tests	Number of participants with treatment-related adverse events as assessed by laboratory test abnormalities.	84 days treatment
Primary	Drug Safety- Electrocardiographic	Number of participants with emergent abnormal electrocardiograms.	84 days treatment
Primary	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
Primary	Drug Tolerability- Adverse events	Incidence of adverse events (AE).	84 days treatment
Secondary	Cognitive change-MMSE	Change in MiniMental State Examination (MMSE) score (0-30, higher score better).	84 days treatment
Secondary	Cognitive change-ADAScog	Change in Alzheimer's Disease Assessment Scale (ADAScog) score (0-70, higher score worse).	84 days treatment
Secondary	Cognitive change-Executive	Change in Trails A (0 - 150 sec) and Trails B test scores (0-300 sec), higher scores worse.	84 days treatment
Secondary	Cognitive change-Language	Change in Verbal Fluency tests for animals and letters (both minimum 0, no maximum, higher scores better).	84 days treatment
Secondary	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
Secondary	Functional performance-CDR	Change in Clinical Disease Rating Scale (0 - 3, higher score worse).	84 days treatment
Secondary	Behavioral Scale - NPI-Q	Change in Neuropsychiatric Inventory Questionnaire (NPI-Q) (0-36, higher scores worse).	84 days treatment
Secondary	Pharmacodynamics - cytokines	Changes in biomarker measurements of plasma levels of cytokines (IFN-?, IL-1ß, IL-4, IL-5, IL-6, IL-8, IL-10, IL-12P70, IL-22, and TNFa) by Simoa assay (pg/mL).	84 days treatment
Secondary	Pharmacodynamics - neuronal biomarkers	Changes in biomarker measurements of plasma levels of tau protein and NfL protein by Simoa assay (pg/mL).	84 days treatment