Alzheimer DiseasePhase 2SKI-ADNCT05194163
MW150 Stress Kinase Inhibitor in Mild to Moderate Alzheimer's Disease
A Phase 2 study testing MW150 in people with Alzheimer Disease, run by Neurokine Therapeutics at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- MW150
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2022to 30 Nov 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- Must have adequate hearing and visual abilities.
- MMSE score of 14 to 28.
- Clinical Dementia Rating (CDR) Global score of 0.5 to 2.0 inclusive.
- Absence of suicidal ideation for at least 1 year.
- Absence of medical conditions that could affect ability to participate in study.
- MRI within 1 year of screening, not showing clinically significant structural lesions. Subjects without available MRI within 1 year, must have an MRI performed for eligibility.
- Stable neuropsychiatric medications for at least 2 months prior to screening.
- If female, must not be of childbearing potential, as defined by being postmenopausal (more than 1 year without periods) or surgically sterile for at least 6 months prior to screening.
- If male, must agree to use contraception if with a potentially childbearing partner.
Who cannot join
- 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.
- Known history of human immunodeficiency virus (HIV) infection.
- Known immune disorder that has a history of requiring treatment with immunosuppressive drugs within the past 1 year.
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- Have a drug or alcohol abuse within 12 months prior to screening.
- Clinically significant laboratory abnormalities at screening.
- Screening ECG showing repeated QTcF > 480 msec, or other clinically significant ECG abnormalities.
- Clinically significant structural brain abnormalities, such as hydrocephalus or intra-axial brain tumors.
- Participation in another investigational study within 30 days or 5 half-lives prior to screening, whichever is greater.
- Participation in another study that would have cognitive testing during the duration of this study.
- History of Covid19 or other viral infections within 3 months.
- Have a clinically significant medical, surgical, laboratory, or behavioral abnormality, which in the judgment of the Investigator makes the subject unsuitable for the study.
Trial locations and contacts
1 site in 1 country.
Wayne P Anderson, PhD contact
United States1 site
Columbia University Irving Medical Center
New York, New York, 10032
Lawrence S Honig, MD PhD, 212-305-9194, lh456@cumc.columbia.edu
Katrina Cuasay, AB, 2123052077, kc2305@cumc.columbia.edu
About this study
Official title: A Phase 2a Study of MW150 Stress Kinase Inhibitor in Mild to Moderate Alzheimer's Disease
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.
- Conditions
- Alzheimer Disease
- Being tested
- MW150, Placebo
- Keywords
- p38alphaMAPK; dementia
- Medical subject headings
- Alzheimer Disease, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MW150Drug
Also called MW01-18-150SRM
oral-delivered capsule of study drug
PlaceboDrug
oral delivered capsule matched to study drug capsule
| Study group | Role | What they receive |
|---|---|---|
| 10mg MW150 daily | Experimental | 10 mg MW150 daily (1 capsule of 10 mg daily) Receives: Drug: MW150 |
| placebo daily | Placebo comparator | placebo daily (1 capsule of matched placebo daily) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Drug Safety- Blood tests
Number of participants with treatment-related adverse events as assessed by laboratory test abnormalities.
Measured: 84 days treatment
Drug Safety- Electrocardiographic
Number of participants with emergent abnormal electrocardiograms.
Measured: 84 days treatment
Drug Safety- C-SSRS
Development of any suicidality on COLUMBIA-SUICIDE SEVERITY RATING SCALE (C-SSRS) score (minimum 0, no maximum, higher number worse).
Measured: 84 days treatment
Drug Tolerability- Adverse events
Incidence of adverse events (AE).
Measured: 84 days treatment
Secondary outcomes (9)
Cognitive change-MMSE
Change in MiniMental State Examination (MMSE) score (0-30, higher score better).
Measured: 84 days treatment
Cognitive change-ADAScog
Change in Alzheimer's Disease Assessment Scale (ADAScog) score (0-70, higher score worse).
Measured: 84 days treatment
Cognitive change-Executive
Change in Trails A (0 - 150 sec) and Trails B test scores (0-300 sec), higher scores worse.
Measured: 84 days treatment
Cognitive change-Language
Change in Verbal Fluency tests for animals and letters (both minimum 0, no maximum, higher scores better).
Measured: 84 days treatment
Functional performance- ADCS-ADL
Change in Alzheimers Disease Cooperative Study Activities of Daily Living (ADCS-ADL) scale (0 - 78, higher score better).
Measured: 84 days treatment
Functional performance-CDR
Change in Clinical Disease Rating Scale (0 - 3, higher score worse).
Measured: 84 days treatment
Behavioral Scale - NPI-Q
Change in Neuropsychiatric Inventory Questionnaire (NPI-Q) (0-36, higher scores worse).
Measured: 84 days treatment
Pharmacodynamics - cytokines
Changes in biomarker measurements of plasma levels of cytokines (IFN-γ, IL-1β, IL-4, IL-5, IL-6, IL-8, IL-10, IL-12P70, IL-22, and TNFα) by Simoa assay (pg/mL).
Measured: 84 days treatment
Pharmacodynamics - neuronal biomarkers
Changes in biomarker measurements of plasma levels of tau protein and NfL protein by Simoa assay (pg/mL).
Measured: 84 days treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2022
- Study start1 May 2022 (estimated)
- Primary completion31 Aug 2024 (estimated)
- Study completion30 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- double-blind randomized placebo-controlled
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Neurokine Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Columbia University, National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Lawrence S Honig, MD, PhD, FAAN, Columbia University
- Investigators
- Lawrence S Honig, MD PhD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05194163
- Sponsor's protocol ID
- MW150-AD-201
- Other IDs
- R44AG071388
- Acronym
- SKI-AD
- Status last verified
- Mar 2022
- First submitted
- 13 Jan 2022
- Last updated
- 29 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Once study complete, de-identified participant data will be shared upon request by investigators from an academic institution.
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a Study of MW150 Stress Kinase Inhibitor in Mild to Moderate Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT05194163
- Acronym / sponsor ID
- SKI-AD / MW150-AD-201
- Conditions
- Alzheimer Disease
- Keywords
- p38alphaMAPK; dementia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Neurokine TherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- Columbia University, National Institute on Aging (NIA)
- Study start
- 1 May 2022 (estimated)
- Primary completion
- 31 Aug 2024 (estimated)
- Study completion
- 30 Nov 2024 (estimated)
- First posted
- 18 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- double-blind randomized placebo-controlled
| Arm | Type | Receives |
|---|---|---|
| 10mg MW150 daily | Experimental | Drug: MW15010 mg MW150 daily (1 capsule of 10 mg daily) |
| placebo daily | Placebo comparator | Drug: Placeboplacebo daily (1 capsule of matched placebo daily) |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
- Known history of human immunodeficiency virus (HIV) infection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MW150Also: MW01-18-150SRMoral-delivered capsule of study drug | Drug | 10mg MW150 daily |
| Placebooral delivered capsule matched to study drug capsule | Drug | placebo daily |
Primary outcome
Drug Safety- Blood tests
Time frame: 84 days treatment
Number of participants with treatment-related adverse events as assessed by laboratory test abnormalities.
Drug Safety- Electrocardiographic
Time frame: 84 days treatment
Number of participants with emergent abnormal electrocardiograms.
Drug Safety- C-SSRS
Time frame: 84 days treatment
Development of any suicidality on COLUMBIA-SUICIDE SEVERITY RATING SCALE (C-SSRS) score (minimum 0, no maximum, higher number worse).
Drug Tolerability- Adverse events
Time frame: 84 days treatment
Incidence of adverse events (AE).
9 secondary outcomes
Cognitive change-MMSE
Time frame: 84 days treatment
Cognitive change-ADAScog
Time frame: 84 days treatment
Cognitive change-Executive
Time frame: 84 days treatment
Cognitive change-Language
Time frame: 84 days treatment
Functional performance- ADCS-ADL
Time frame: 84 days treatment
Functional performance-CDR
Time frame: 84 days treatment
Behavioral Scale - NPI-Q
Time frame: 84 days treatment
Pharmacodynamics - cytokines
Time frame: 84 days treatment
Pharmacodynamics - neuronal biomarkers
Time frame: 84 days treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2022.
- Individual participant dataSharing planned: Yes. Once study complete, de-identified participant data will be shared upon request by investigators from an academic institution.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wayne P Anderson, PhD contact
Lawrence S Honig, MD PhD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MW150 in people with Alzheimer Disease, run by Neurokine Therapeutics at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lawrence S Honig, MD PhD (2123059194, lh456@cumc.columbia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Drug Safety- Blood tests (time frame: 84 days treatment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2022.