24 Participants Needed

MW150 for Alzheimer's Disease

(SKI-AD Trial)

LS
WP
Overseen ByWayne P Anderson, PhD
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Neurokine Therapeutics
Must be taking: Neuropsychiatric medications
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

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 MW150 safe for humans?

AF150(S), which is similar to MW150, has been tested in animals and showed a high safety margin, meaning it was safe at much higher doses than needed for effectiveness. This suggests it might be generally safe, but specific human safety data for MW150 is not provided.12345

How does the drug MW150 differ from other Alzheimer's treatments?

MW150 is unique because it acts as a full agonist on m1 muscarinic receptors, which may help delay Alzheimer's progression by enhancing the secretion of amyloid precursor protein derivatives and reducing tau phosphorylation, potentially improving memory and learning deficits.14678

What is the purpose of this trial?

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.

Research Team

LS

Lawrence S Honig, MD PhD

Principal Investigator

Columbia University

Eligibility Criteria

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.
See 11 more

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
See 11 more

Timeline

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

Treatment Details

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.
Participant Groups
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)

Find a Clinic Near You

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+

Findings from Research

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.
Efficacy and safety of BMY 21,502 in Alzheimer disease.Shrotriya, RC., Cutler, NR., Sramek, JJ., et al.[2017]
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.
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]
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.
M1 muscarinic agonists target major hallmarks of Alzheimer's disease--the pivotal role of brain M1 receptors.Fisher, A.[2008]

References

AF150(S): a new functionally selective M1 agonist improves cognitive performance in rats. [2019]
AF150(S) and AF267B: M1 muscarinic agonists as innovative therapies for Alzheimer's disease. [2018]
Efficacy and safety of BMY 21,502 in Alzheimer disease. [2017]
Safety, tolerability, pharmacokinetics and effects of diet on AD16, a novel neuroinflammatory inhibitor for Alzheimer's disease: a randomized phase 1 study. [2023]
M1 muscarinic agonists target major hallmarks of Alzheimer's disease--the pivotal role of brain M1 receptors. [2008]
SEN1500, a novel oral amyloid-β aggregation inhibitor, attenuates brain pathology in a mouse model of Alzheimer's disease. [2018]
Facilitation of memory performance by a novel muscarinic agonist in young and old rats. [2019]
M1 agonists for the treatment of Alzheimer's disease. Novel properties and clinical update. [2019]
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