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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05602727




Registration number
NCT05602727
Ethics application status
Date submitted
27/10/2022
Date registered
2/11/2022

Titles & IDs
Public title
Efficacy and Safety of MK-1942 as an Adjunct Therapy in Participants With Mild to Moderate Alzheimer's Disease Dementia (MK-1942-008)
Scientific title
A Phase 2a/2b Randomized, Placebo-Controlled Clinical Study To Evaluate The Safety And Efficacy Of MK-1942 As Adjunctive Therapy In Participants With Mild To Moderate Alzheimer's Disease Dementia
Secondary ID [1] 0 0
MK-1942-008
Secondary ID [2] 0 0
1942-008
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alzheimer's Disease 0 0
Condition category
Condition code
Neurological 0 0 0 0
Alzheimer's disease
Neurological 0 0 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - MK-1942
Treatment: Drugs - Placebo

Experimental: MK-1942 5 mg - Participants will receive a single 5 mg MK-1942 capsule twice daily (BID), taken orally for 12 weeks. A mock titration will be done to maintain the study blind despite no changes in dose.

Experimental: MK-1942 15 mg - Participants will receive a single 8 mg MK-1942 capsule twice daily (BID), taken orally for one week. Then the dose is titrated up to 15 mg MK-1942 capsule twice daily (BID), taken orally for up to 11 weeks.

Placebo comparator: Placebo - Participants will receive a placebo capsule twice daily (BID), taken orally for 12 weeks. A mock titration will be done to maintain the study blind despite no changes in dose.


Treatment: Drugs: MK-1942
MK-1942 oral capsule

Treatment: Drugs: Placebo
Placebo oral capsule
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline in the Alzheimer's Disease Assessment Scale-11-item Cognitive Subscale (ADAS-Cog11) Score at Week 12
Timepoint [1] 0 0
Baseline and Week 12
Primary outcome [2] 0 0
Number of Participants Experiencing an Adverse Event (AE)
Timepoint [2] 0 0
Up to ~ 14 Weeks
Primary outcome [3] 0 0
Number of Participants Discontinuing Study Medication Due to an Adverse Event
Timepoint [3] 0 0
Up to ~ 12 Weeks
Secondary outcome [1] 0 0
Alzheimer's Disease Cooperative Study Clinical Global Impression of Change (ADCS-CGIC) Overall Score at Week 12
Timepoint [1] 0 0
Week 12
Secondary outcome [2] 0 0
Mean Change From Baseline in The Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL) Total Score at Week 12
Timepoint [2] 0 0
Baseline and Week 12

Eligibility
Key inclusion criteria
* Has mild to moderate AD dementia based on the national institute of neurological and communicative diseases and stroke/Alzheimer's Disease and related disorders association (NINCDS-ADRDA) criteria.
* Has mini-mental state examination (MMSE) score between 12-22 (inclusive) at screening.
* Is using acetylcholinesterase inhibitors (AChEI) therapy for management of AD dementia at Screening and during the study. These medications must be at stable approved dose levels =3 months before the first dose of study intervention and the regimens must remain constant throughout the study to the extent that is clinically appropriate.
* Has a designated study partner who can fulfill the requirements of this study. The study partner will need to spend sufficient time with the participant to be familiar with their overall function and behavior and be able to provide adequate information about the participant needed for the study including, knowledge of functional and basic activities of daily life, work/educational history, cognitive performance, emotional/psychological state, and general health status.
Minimum age
55 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Has a known history of stroke or cerebrovascular disease that is clinically important in the investigator's opinion.
* Has diagnosis of a clinically relevant central nervous system (CNS) disease other than AD dementia (with protocol-specified exceptions).
* Has a history of seizures or epilepsy within the 10 years preceding Screening.
* Has any other major CNS trauma, or infections that affect brain function.
* Has evidence of a clinically relevant or unstable psychiatric disorder, based on criteria from the diagnostic and statistical manual of mental disorders (fifth edition), including schizophrenia or other psychotic disorder, bipolar disorder, major depression, or delirium. Major depression in remission is not exclusionary.
* Has a severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or administration intervention.
* Has a history of malignancy occurring within the 5 years immediately before Screening, except for a participant who has been adequately treated for 1 or more of the following: basal cell or squamous cell skin cancer; in situ cervical cancer; localized prostate carcinoma; who has undergone potentially curative therapy with no evidence of recurrence for =3 years post-therapy, and who is deemed to be at low risk for recurrence.
* Has a risk factor for QTc prolongation.
* Has a history of alcoholism or drug dependency/abuse within the 5 years preceding screening.
* Has a known allergy or intolerance to the active or inert ingredients in MK-1942.
* Has received any anti-amyloid agents or antibodies, or any of the following medications: CNS-penetrant anticholinergics, neuroleptics, anticonvulsants, narcotics, glutamatergic agents, agents with possible psychotropic effects, and experimental acute respiratory syndrome coronavirus 2 (COVID-19) therapies.
* Has liver disease, including but not limited to chronic viral hepatitis, non viral hepatitis, cirrhosis, malignancies, autoimmune liver diseases.
* Has an abnormal thyroid-stimulating hormone (TSH) value if confirmed by abnormal T4 value.
* Resides in a nursing home or assisted care facility with need for direct continuous medical care and nursing supervision. Participant may reside in such facilities provided continuous direct medical care is not required and a qualified study partner is available for coparticipation and the participant is physically able to attend all required study visits.
* Had major surgical procedure or donated or lost >1 unit of blood (approximately 500 mL) within the 4 weeks before screening.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
2/12/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
27/09/2023
Sample size
Target
Accrual to date
Final
99
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
KARA Institute for Neurological Diseases ( Site 1902) - Sydney
Recruitment hospital [2] 0 0
Austin Health-Medical & Cognitive Research Unit ( Site 1901) - Ivanhoe
Recruitment hospital [3] 0 0
HammondCare ( Site 1903) - Malvern
Recruitment postcode(s) [1] 0 0
2113 - Sydney
Recruitment postcode(s) [2] 0 0
3079 - Ivanhoe
Recruitment postcode(s) [3] 0 0
3144 - Malvern
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Louisiana
Country [7] 0 0
United States of America
State/province [7] 0 0
New Jersey
Country [8] 0 0
United States of America
State/province [8] 0 0
New York
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United States of America
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North Carolina
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United States of America
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Ohio
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United States of America
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Oregon
Country [12] 0 0
United States of America
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Texas
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United States of America
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Vermont
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United States of America
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Virginia
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United States of America
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Washington
Country [16] 0 0
Argentina
State/province [16] 0 0
Buenos Aires
Country [17] 0 0
Argentina
State/province [17] 0 0
Caba
Country [18] 0 0
Argentina
State/province [18] 0 0
Cordoba
Country [19] 0 0
Canada
State/province [19] 0 0
British Columbia
Country [20] 0 0
Canada
State/province [20] 0 0
Nova Scotia
Country [21] 0 0
Canada
State/province [21] 0 0
Ontario
Country [22] 0 0
Canada
State/province [22] 0 0
Quebec
Country [23] 0 0
Colombia
State/province [23] 0 0
Antioquia
Country [24] 0 0
Colombia
State/province [24] 0 0
Distrito Capital De Bogota
Country [25] 0 0
Colombia
State/province [25] 0 0
Valle Del Cauca
Country [26] 0 0
Italy
State/province [26] 0 0
Lazio
Country [27] 0 0
Italy
State/province [27] 0 0
Lombardia
Country [28] 0 0
Italy
State/province [28] 0 0
Brescia
Country [29] 0 0
Japan
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Hyogo
Country [30] 0 0
Japan
State/province [30] 0 0
Kagawa
Country [31] 0 0
Japan
State/province [31] 0 0
Kanagawa
Country [32] 0 0
Japan
State/province [32] 0 0
Osaka
Country [33] 0 0
Japan
State/province [33] 0 0
Tokyo
Country [34] 0 0
Japan
State/province [34] 0 0
Kyoto
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Korea, Republic of
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Incheon
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Korea, Republic of
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Seoul
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New Zealand
State/province [37] 0 0
Canterbury
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Spain
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Barcelona
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Spain
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Cataluna
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Spain
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Navarra
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Spain
State/province [41] 0 0
Pais Vasco
Country [42] 0 0
Spain
State/province [42] 0 0
Valenciana, Comunitat
Country [43] 0 0
Spain
State/province [43] 0 0
Madrid
Country [44] 0 0
Spain
State/province [44] 0 0
Zaragoza
Country [45] 0 0
United Kingdom
State/province [45] 0 0
Edinburgh, City Of
Country [46] 0 0
United Kingdom
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Glasgow City
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United Kingdom
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London, City Of
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United Kingdom
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Wiltshire
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United Kingdom
State/province [49] 0 0
Birmingham
Country [50] 0 0
United Kingdom
State/province [50] 0 0
Plymouth

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Merck Sharp & Dohme LLC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Merck Sharp & Dohme LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: http://engagezone.msd.com/ds_documentation.php


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT05602727