UnknownPhase 2

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

United States24 participantsStarted 2022-05-01

Plain-language 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.

Who can participate

Age range50 Years – 90 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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.

What they're measuring

Drug Safety- Blood tests

Timeframe: 84 days treatment

Drug Safety- Electrocardiographic

Timeframe: 84 days treatment

Drug Safety- C-SSRS

Timeframe: 84 days treatment

Drug Tolerability- Adverse events

Timeframe: 84 days treatment

Trial details

NCT IDNCT05194163

SponsorNeurokine Therapeutics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-08-31

Contact for this trial

Lawrence S Honig, MD PhD

2123059194 lh456@cumc.columbia.edu

View on ClinicalTrials.gov More Alzheimer Disease trials

Plain-language summary

Who can participate

Age range50 Years – 90 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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.