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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-01

Study Completion Date

2024-11-30

Brief Summary

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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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Detailed Description

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Conditions

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Alzheimer Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

double-blind randomized placebo-controlled

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Subjects will be randomized through a computerized system by a Data/Statistics Group independent from the investigator or Sponsor

Study Groups

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10mg MW150 daily

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

Group Type EXPERIMENTAL

MW150

Intervention Type DRUG

oral-delivered capsule of study drug

placebo daily

placebo daily (1 capsule of matched placebo daily)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

oral delivered capsule matched to study drug capsule

Interventions

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MW150

oral-delivered capsule of study drug

Intervention Type DRUG

Placebo

oral delivered capsule matched to study drug capsule

Intervention Type DRUG

Other Intervention Names

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MW01-18-150SRM

Eligibility Criteria

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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.

Minimum Eligible Age

50 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No