What side effects are associated with this type of intervention?

The most common treatments for Alzheimer's Disease include acetylcholinesterase inhibitors (such as donepezil and galantamine) and memantine. Known side effects of acetylcholinesterase inhibitors can include gastrointestinal issues (nausea, vomiting, diarrhea), muscle cramps, fatigue, and insomnia. Memantine may cause dizziness, headache, confusion, and constipation. While specific data on p38alphaMAPK kinase inhibitors like MW150 is limited, the general side effects of investigational drugs in Alzheimer's trials often include similar cognitive and gastrointestinal symptoms.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of Alzheimer's Disease, primarily focusing on cholinesterase inhibitors (such as donepezil, rivastigmine, and galantamine) and NMDA receptor antagonists (such as memantine). These treatments aim to manage symptoms but do not cure the disease. While MW150, a p38alphaMAPK kinase inhibitor, is still under investigation, there are no current FDA-approved Alzheimer's treatments specifically targeting this pathway. The focus remains on symptomatic relief and slowing disease progression.

What other types of research exist?

Promising novel alternatives to MW150 for Alzheimer's Disease treatment in 2024 include: 1) Lecanemab, a monoclonal antibody targeting amyloid-beta, recently approved by the FDA. 2) Donanemab, another monoclonal antibody targeting amyloid plaques, showing positive results in clinical trials. 3) Gene therapy approaches like CRISPR-Cas9 targeting amyloid precursor protein (APP) or tau protein. 4) BACE inhibitors, which reduce amyloid-beta production, such as elenbecestat. These alternatives represent diverse mechanisms of action and have shown potential in modifying disease progression.

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Stress Kinase Inhibitor

MW150 for Alzheimer's Disease (SKI-AD Trial)

Phase 2

Waitlist Available

Led By Lawrence S Honig, MD PhD

Research Sponsored by Neurokine Therapeutics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Male or female, age 50 to 90 inclusive

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

Must not have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 84 days treatment

Summary

This trial is testing a new pill called MW150 for people with mild-to-moderate Alzheimer's disease. The pill works by blocking a brain protein that may cause Alzheimer's symptoms. The study aims to see if the pill is safe and if it helps improve memory and daily activities.

Who is the study for?

This trial is for men and women aged 50-90 with mild-to-moderate Alzheimer's Disease, who have a study partner and can speak English fluently. Participants must not have significant other medical conditions or psychiatric disorders, no recent drug/alcohol abuse, and if female, be non-childbearing. Males must agree to use contraception.

What is being tested?

The trial tests MW150, an oral drug believed to affect stress kinases involved in Alzheimer's. It compares the effects of MW150 against a placebo on safety, how the body processes it, cognitive performance, daily activities behavior and blood biomarkers.

What are the potential side effects?

Specific side effects are not listed but will include monitoring for any adverse reactions related to the investigational drug MW150 as compared to a placebo. Safety assessments will focus on tolerability and potential impacts on liver function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 50 and 90 years old.

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I have been diagnosed with Alzheimer's Disease.

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I have someone who can come with me to appointments and sees me often.

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I am a woman who cannot become pregnant because I am postmenopausal or have been surgically sterilized.

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I can hear and see well enough for daily activities.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have central nervous system disorders other than Alzheimer's.

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I do not have any serious or unstable health conditions.

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I do not have major brain abnormalities like hydrocephalus or brain tumors.

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I have chronic hepatitis B or C.

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I have an immune disorder treated with immunosuppressants in the last year.

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I have been diagnosed with HIV.

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I have had COVID-19 or another viral infection in the last 3 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 84 days treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~84 days treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and 84 days treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Drug Safety- Blood tests

Drug Safety- C-SSRS

Drug Safety- Electrocardiographic

+1 more

Secondary study objectives

Behavioral Scale - NPI-Q

Cognitive change-ADAScog

Cognitive change-Executive

+6 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: 10mg MW150 dailyExperimental Treatment1 Intervention

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

Group II: placebo dailyPlacebo Group1 Intervention

placebo daily (1 capsule of matched placebo daily)

0 / 12Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Alzheimer's Disease include cholinesterase inhibitors (e.g., donepezil, rivastigmine) and NMDA receptor antagonists (e.g., memantine). Cholinesterase inhibitors work by preventing the breakdown of acetylcholine, a neurotransmitter important for learning and memory, thereby enhancing cholinergic function. NMDA receptor antagonists help regulate glutamate activity to prevent excitotoxicity, which can damage neurons. These treatments are symptomatic and aim to improve cognitive function and slow disease progression. The investigational drug MW150, a p38alphaMAPK kinase inhibitor, targets neuroinflammation by inhibiting a specific stress kinase pathway involved in inflammatory responses. This approach is significant as neuroinflammation is a key factor in Alzheimer's pathogenesis, and reducing it may help protect neurons and improve clinical outcomes.