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

24 Participants Needed

What You Need to Know Before You Apply

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.

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. ^{1 2 3 4 5}

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. ^{1 4 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

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]

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]

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]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

AF150(S): a new functionally selective M1 agonist improves cognitive performance in rats. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

AF150(S) and AF267B: M1 muscarinic agonists as innovative therapies for Alzheimer's disease. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Efficacy and safety of BMY 21,502 in Alzheimer disease. [2017]

4. England 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. [2023]

5. Switzerland pubmed.ncbi.nlm.nih.gov

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

6. Ireland pubmed.ncbi.nlm.nih.gov

SEN1500, a novel oral amyloid-β aggregation inhibitor, attenuates brain pathology in a mouse model of Alzheimer's disease. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

Facilitation of memory performance by a novel muscarinic agonist in young and old rats. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

M1 agonists for the treatment of Alzheimer's disease. Novel properties and clinical update. [2019]