Clinical trial NCT05194163: MW150 Stress Kinase Inhibitor in Mild to Moderate Alzheimer's Disease
Official title: A Phase 2a Study of MW150 Stress Kinase Inhibitor in Mild to Moderate Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Alzheimer Disease
Keywords: p38alphaMAPK; dementia
Lead sponsor: Neurokine Therapeutics
Sponsor class: INDUSTRY
Collaborators: name: Columbia University
name: National Institute on Aging (NIA)
First posted: 2022-01-18
Enrollment: 24
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: double-blind randomized placebo-controlled
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Drug Safety- Blood tests
timeFrame: 84 days treatment
measure: Drug Safety- Electrocardiographic
timeFrame: 84 days treatment
measure: Drug Safety- C-SSRS
timeFrame: 84 days treatment
measure: Drug Tolerability- Adverse events
timeFrame: 84 days treatment
Secondary outcomes:
measure: Cognitive change-MMSE
timeFrame: 84 days treatment
measure: Cognitive change-ADAScog
timeFrame: 84 days treatment
measure: Cognitive change-Executive
timeFrame: 84 days treatment
measure: Cognitive change-Language
timeFrame: 84 days treatment
measure: Functional performance- ADCS-ADL
timeFrame: 84 days treatment
measure: Functional performance-CDR
timeFrame: 84 days treatment
measure: Behavioral Scale - NPI-Q
timeFrame: 84 days treatment
measure: Pharmacodynamics - cytokines
timeFrame: 84 days treatment
measure: Pharmacodynamics - neuronal biomarkers
timeFrame: 84 days treatment
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Irving Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: Lawrence S Honig, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: