MW150 for Alzheimer's Disease

(SKI-AD Trial)

Overseen By Wayne P Anderson, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Neurokine Therapeutics

Must be taking: Neuropsychiatric medications

Disqualifiers: CNS disorders, Serious medical disease, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new oral treatment called MW150 for individuals with mild-to-moderate Alzheimer's disease. Researchers aim to determine the drug's safety and how it moves through the body. They also seek to understand its effects on memory, daily activities, and behavior. English-speaking individuals diagnosed with Alzheimer's disease who can bring a study partner to appointments might be suitable candidates for this trial. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group, offering participants an opportunity to contribute to significant advancements in Alzheimer's care.

Will I have to stop taking my current medications?

The trial requires that your neuropsychiatric medications be stable for at least 2 months before starting. It doesn't specify about other medications, so you should discuss your current medications with the study team.

Is there any evidence suggesting that MW150 is likely to be safe for humans?

Research has shown that MW150 has potential, particularly in early animal studies. In mice with Alzheimer's disease, MW150 reduced inflammation and improved brain function. However, these findings are preliminary. The current trial is a phase 2 study, aiming to learn more about the drug's safety in humans and its tolerability. Since MW150 is not yet approved for any condition, this phase is crucial for understanding its safety in people with Alzheimer's. Participants should know that this phase gathers important safety information but does not yet guarantee the drug's safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Alzheimer's?

Researchers are excited about MW150 for Alzheimer's disease because it targets a new mechanism of action. Unlike current treatments that mainly focus on addressing symptoms or modifying neurotransmitter levels, MW150 works by modulating inflammation in the brain, which is believed to be a key factor in the progression of Alzheimer's. This unique approach could potentially slow down or alter the course of the disease, offering hope for more effective management of Alzheimer's compared to existing options.

What evidence suggests that MW150 might be an effective treatment for Alzheimer's?

Research has shown that MW150, a drug that blocks a specific protein, may help treat Alzheimer's disease. In earlier studies, MW150 improved behavior and thinking in animals and reduced the loss of brain connections, a major issue in Alzheimer's. This trial will compare the effects of 10 mg MW150 daily to a placebo. These findings suggest that MW150 could improve memory and thinking in people with Alzheimer's. Although more research is needed, the early results offer promise for those seeking new treatment options. ^{1 3 6 7 8}

Who Is on the Research Team?

Lawrence S Honig, MD PhD

Principal Investigator

Columbia University

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

My mental health medications have been the same for the last 2 months.

Absence of suicidal ideation for at least 1 year

I am between 50 and 90 years old.

Exclusion Criteria

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

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

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 10 mg MW150 or placebo daily for 84 days to assess safety, tolerability, and effects on cognitive performance and biomarkers

12 weeks

Regular visits for monitoring and assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• MW150

Trial Overview 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.

How Is the Trial Designed?

Group I: 10mg MW150 daily Experimental Treatment 1 Intervention

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

Group II: placebo daily Placebo Group 1 Intervention

placebo daily (1 capsule of matched placebo daily)

Who Is Running the Clinical Trial?

Neurokine Therapeutics

Lead Sponsor

Trials

1

Recruited

20+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Columbia University

Collaborator

Trials

1,529

Recruited

2,832,000+

Published Research Related to This Trial

AF267B, an M1-selective muscarinic agonist, has shown promise in reducing beta-amyloid levels in both rabbits and triple transgenic mice models of Alzheimer's disease, indicating its potential as a cognitive enhancer and disease modifier.

The mechanism of action for AF267B involves the activation of M1 mAChR, which leads to reduced cognitive deficits and decreases in both beta-amyloid and tau pathologies, highlighting its role in targeting key hallmarks of Alzheimer's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

M1 muscarinic agonists target major hallmarks of Alzheimer's disease--the pivotal role of brain M1 receptors. Fisher, A.[2008]

AD16, a new drug candidate for Alzheimer's disease, showed a favorable safety and tolerability profile in a study involving 62 healthy Chinese adults, with no serious adverse events reported.

The pharmacokinetics of AD16 indicated that its absorption rate is slowed by high-fat meals, but this does not affect the overall absorption, suggesting it can be effectively administered regardless of meal conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety, tolerability, pharmacokinetics and effects of diet on AD16, a novel neuroinflammatory inhibitor for Alzheimer's disease: a randomized phase 1 study. Peng, D., Xu, S., Zou, T., et al.[2023]

In a study of 69 patients with mild-to-moderate Alzheimer's disease, BMY 21,502 showed a slight improvement in cognitive scores compared to placebo, particularly in patients with moderate dementia, but these results were not statistically significant.

While BMY 21,502 was generally well tolerated, it was associated with higher rates of abnormal liver enzyme levels and nausea, leading to a higher discontinuation rate among patients compared to the placebo group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of BMY 21,502 in Alzheimer disease. Shrotriya, RC., Cutler, NR., Sramek, JJ., et al.[2017]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05194163

MW150 Stress Kinase Inhibitor in Mild to Moderate ... 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.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11331815/

A small molecule p38α MAPK inhibitor, MW150, attenuates ... MW150 successfully reduced behavioral impairment in the Morris Water Maze, corresponding with attenuation of synaptic loss, reduction in tau ...

3. reporter.nih.gov reporter.nih.gov/project-details/10157610

Development of a stress kinase inhibitor therapeutic candidate ... MW150 development was based on the perspective that Alzheimer's and related diseases are disorders of progressive synaptic dysfunction with a common ...

4. withpower.com withpower.com/trial/phase-2-alzheimer-disease-1-2022-07250

MW150 for Alzheimer's Disease · Info for Participants In a study of 69 patients with mild-to-moderate Alzheimer's disease, BMY 21,502 showed a slight improvement in cognitive scores compared to placebo, ...

5. alz-journals.onlinelibrary.wiley.com alz-journals.onlinelibrary.wiley.com/doi/10.1002/trc2.12465

Alzheimer's disease drug development pipeline: 2024 There are 164 trials assessing 127 drugs across the 2024 AD pipeline. There were 48 trials in Phase 3 testing 32 drugs, 90 trials in Phase 2 assessing 81 drugs ...

6. alzdiscovery.org alzdiscovery.org/research-and-grants/portfolio-details/4088

Neurokine Therapeutics MW150 is efficacious in both preventive and disease stage therapeutic treatment paradigms. It improves outcomes in distinct models of Alzheimer's disease and ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10582128/

Alzheimer's Disease: Novel Targets and Investigational Drugs ... In transgenic mouse models of AD, MW150 suppressed release of inflammatory cytokines and improved synaptic function. Mice treated with MW150 ...

8. ctv.veeva.com ctv.veeva.com/study/mw150-stress-kinase-inhibitor-in-mild-to-moderate-alzheimers-disease

MW150 Stress Kinase Inhibitor in Mild to Moderate ... This study is a phase 2a randomized double-blind, placebo-controlled, study, in mild-to-moderate Alzheimer's disease, ...