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Efficacy and Safety of MK-1942 as an Adjunct Therapy in Participants With Mild to Moderate Alzheimer's Disease Dementia (MK-1942-008)

Primary Purpose

Alzheimer's Disease

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
MK-1942
Placebo
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer's Disease focused on measuring Alzheimer's Disease

Eligibility Criteria

55 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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. 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.

Sites / Locations

  • Banner Alzheimer's Institute ( Site 0017)
  • Neurology Center of North Orange County ( Site 0039)
  • California Neuroscience Research, LLC ( Site 0058)
  • JEM Research Institute ( Site 0013)
  • Velocity Clinical Research, Hallandale Beach ( Site 0025)
  • K2 Medical Research ( Site 0057)
  • Premier Clinical Research Institute ( Site 0038)
  • Collier Neurologic Specialists ( Site 0045)
  • Atlanta Center for Medical Research ( Site 0044)
  • iResearch Atlanta ( Site 0016)
  • Alexian Brothers Medical Center ( Site 0011)
  • Tandem Clinical Research ( Site 0055)
  • Global Medical Institutes LLC; Princeton Medical Institute ( Site 0053)
  • Advanced Memory Research Institute of New Jersey ( Site 0027)
  • Richmond Behavioral Associates ( Site 0008)
  • AMC Research, LLC ( Site 0004)
  • NeuroScience Research Center ( Site 0009)
  • Summit Headlands ( Site 0018)
  • Grayline Research Center ( Site 0003)
  • The Memory Clinic ( Site 0054)
  • Re:Cognition Health ( Site 0031)
  • Northwest Clinical Research Center ( Site 0056)
  • Clinica Privada Banfield ( Site 0205)
  • Hospital Italiano de Buenos Aires-Geriatrics ( Site 0210)
  • Instituto Kremer ( Site 0202)
  • IDIM - Instituto de Diagnóstico e Investigaciones Metabólicas ( Site 0204)
  • Instituto Geriatrico Nuestra Señora de Las Nieves ( Site 0208)
  • Fundación para la Lucha contra las Enfermedades Neurológicas de la Infancia (FLENI) ( Site 0201)
  • KARA Institute for Neurological Diseases ( Site 1902)
  • Austin Health-Medical & Cognitive Research Unit ( Site 1901)
  • HammondCare ( Site 1903)
  • OCT Research ULC ( Site 0113)
  • Centricity Research - Halifax ( Site 0111)
  • Ottawa Memory Clinic ( Site 0105)
  • Sunnybrook Health Sciences Centre ( Site 0106)
  • Toronto Western Hospital-Memory clinic ( Site 0102)
  • Clinique de la Mémoire de l'Outaouais ( Site 0114)
  • Instituto Neurológico de Colombia ( Site 0415)
  • Grupo Neurociencias de Antioquia ( Site 0417)
  • Centro de Investigaciones del Sistema Nervioso - Grupo Cisne ( Site 0414)
  • Fundacion Valle del Lili- CIC ( Site 0418)
  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore (
  • Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico-UOSD Malattie Neurodegenerative ( Site 1204
  • Ospedale San Raffaele ( Site 1202)
  • Ospedale San Gerardo-ASST Monza-Dipartimento di Neuroscienze ( Site 1201)
  • Centro S Giovanni Di Dio Fatebenefratelli ( Site 1205)
  • Kakigi Cognition and Emotion Clinic of Hope ( Site 2307)
  • Kagawa University Hospital ( Site 2308)
  • Kishiro Mental Clinic ( Site 2310)
  • Kawasaki Saiwai Clinic ( Site 2302)
  • Nagomi Clinic ( Site 2305)
  • Tokyo Metropolitan Geriatric Hospital ( Site 2301)
  • Ishikawa Clinic ( Site 2306)
  • Himuro Neurology Clinic ( Site 2304)
  • Inha University Hospital ( Site 2104)
  • Asan Medical Center-Department of Neurology ( Site 2101)
  • Samsung Medical Center ( Site 2102)
  • Ewha Womans University Seoul Hospital ( Site 2103)
  • CGM Research Trust ( Site 2001)
  • Hospital Universitari Mutua Terrassa-Neurology ( Site 1607)
  • HOSPITAL CLÍNIC DE BARCELONA ( Site 1609)
  • Hospital de la Santa Creu i Sant Pau ( Site 1603)
  • Clinica Universidad de Navarra-Neurology ( Site 1602)
  • Centro de Atención Especializada Oroitu ( Site 1610)
  • Hospital Universitario Doctor Peset-Neurología ( Site 1601)
  • Fundació ACE ( Site 1604)
  • Hospital Clinico San Carlos ( Site 1608)
  • Hospital Viamed Montecanal-Neurociencia ( Site 1606)
  • Brain Health Scotland Life Sciences ( Site 1810)
  • Queen Elizabeth University Hospital-Glasgow Clinical Research Facility ( Site 1808)
  • Re:Cognition Health - London ( Site 1804)
  • Kingshill Research Centre ( Site 1807)
  • Re:Cognition Health - Birmingham ( Site 1801)
  • Re:Cognition Health - Plymouth ( Site 1803)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

MK-1942 5 mg

MK-1942 15 mg

Placebo

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Mean Change From Baseline in the Alzheimer's Disease Assessment Scale-11-item Cognitive Subscale (ADAS-Cog11) Score at Week 12
Mean change from baseline at week 12 is assessed for ADAS-Cog11 score. The ADAS-Cog11 is a structured scale that evaluates memory, orientation, attention, reasoning, language, and constructional praxis. ADAS-Cog11 measures cognition by assessing 11 metrics impaired in AD: word recall; commands; constructional praxis; naming objects and fingers; ideational praxis; orientation; word recognition; remembering test instructions; spoken language ability; word-finding difficulty; and comprehension of spoken language. Higher scores indicate greater impairment.
Number of Participants Experiencing an Adverse Event (AE)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Number of Participants Discontinuing Study Medication due to an Adverse Event
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.

Secondary Outcome Measures

Alzheimer's Disease Cooperative Study Clinical Global Impression of Change (ADCS-CGIC) Overall Score at Week 12
ADCS-CGIC scores are assessed at week 12. The ADCS-CGIC is a global scale assessing cognition and function based on structured interviews of both the participant and study partner. The ADCS-CGIC focuses on clinicians' observations of change in the patient's cognitive, functional, and behavioral performance since the beginning of the study. Improvement in the ADCS-CGIC overall score, with a score of 1, 2, or 3 indicates improvement. The ADCS-CGIC is a clinician-rated measure of: global severity at baseline scored from 1 (normal, not at all ill) to 7 (among the most extremely ill patients); and global change at follow-up scored from 1 (marked improvement) to 7 (marked worsening), where 4 indicates no change.
Mean Change From Baseline in The Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL) Total Score at Week 12
Mean change from baseline at week 12 is assessed for ADCS-ADL score. The ADCS-ADL is an informant-based measure of the patient's functional ability in activities of daily living (ADL). The ADCS-ADL assesses the competence of participants with AD dementia in basic and instrumental ADLs. The ADCS-ADL is a 23 item scale that includes 6 basic ADL tems and 17 instrumental ADL items that provide a total score from 0-78, with a lower score indicating greater severity.

Full Information

First Posted
October 27, 2022
Last Updated
October 20, 2023
Sponsor
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT05602727
Brief Title
Efficacy and Safety of MK-1942 as an Adjunct Therapy in Participants With Mild to Moderate Alzheimer's Disease Dementia (MK-1942-008)
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Terminated
Why Stopped
Voluntarily terminated due to benefit/risk assessment
Study Start Date
December 2, 2022 (Actual)
Primary Completion Date
September 27, 2023 (Actual)
Study Completion Date
September 27, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The main purpose of this study is to assess is to evaluate the safety and efficacy of MK-1942 as adjunctive therapy in participants with mild to moderate Alzheimer's Disease (AD) dementia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
Keywords
Alzheimer's Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
99 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MK-1942 5 mg
Arm Type
Experimental
Arm Description
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.
Arm Title
MK-1942 15 mg
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
MK-1942
Intervention Description
MK-1942 oral capsule
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo oral capsule
Primary Outcome Measure Information:
Title
Mean Change From Baseline in the Alzheimer's Disease Assessment Scale-11-item Cognitive Subscale (ADAS-Cog11) Score at Week 12
Description
Mean change from baseline at week 12 is assessed for ADAS-Cog11 score. The ADAS-Cog11 is a structured scale that evaluates memory, orientation, attention, reasoning, language, and constructional praxis. ADAS-Cog11 measures cognition by assessing 11 metrics impaired in AD: word recall; commands; constructional praxis; naming objects and fingers; ideational praxis; orientation; word recognition; remembering test instructions; spoken language ability; word-finding difficulty; and comprehension of spoken language. Higher scores indicate greater impairment.
Time Frame
Baseline and Week 12
Title
Number of Participants Experiencing an Adverse Event (AE)
Description
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Time Frame
Up to ~ 14 Weeks
Title
Number of Participants Discontinuing Study Medication due to an Adverse Event
Description
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
Time Frame
Up to ~ 12 Weeks
Secondary Outcome Measure Information:
Title
Alzheimer's Disease Cooperative Study Clinical Global Impression of Change (ADCS-CGIC) Overall Score at Week 12
Description
ADCS-CGIC scores are assessed at week 12. The ADCS-CGIC is a global scale assessing cognition and function based on structured interviews of both the participant and study partner. The ADCS-CGIC focuses on clinicians' observations of change in the patient's cognitive, functional, and behavioral performance since the beginning of the study. Improvement in the ADCS-CGIC overall score, with a score of 1, 2, or 3 indicates improvement. The ADCS-CGIC is a clinician-rated measure of: global severity at baseline scored from 1 (normal, not at all ill) to 7 (among the most extremely ill patients); and global change at follow-up scored from 1 (marked improvement) to 7 (marked worsening), where 4 indicates no change.
Time Frame
Week 12
Title
Mean Change From Baseline in The Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL) Total Score at Week 12
Description
Mean change from baseline at week 12 is assessed for ADCS-ADL score. The ADCS-ADL is an informant-based measure of the patient's functional ability in activities of daily living (ADL). The ADCS-ADL assesses the competence of participants with AD dementia in basic and instrumental ADLs. The ADCS-ADL is a 23 item scale that includes 6 basic ADL tems and 17 instrumental ADL items that provide a total score from 0-78, with a lower score indicating greater severity.
Time Frame
Baseline and Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
Facility Information:
Facility Name
Banner Alzheimer's Institute ( Site 0017)
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
Neurology Center of North Orange County ( Site 0039)
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Facility Name
California Neuroscience Research, LLC ( Site 0058)
City
Sherman Oaks
State/Province
California
ZIP/Postal Code
91403
Country
United States
Facility Name
JEM Research Institute ( Site 0013)
City
Atlantis
State/Province
Florida
ZIP/Postal Code
33462
Country
United States
Facility Name
Velocity Clinical Research, Hallandale Beach ( Site 0025)
City
Hallandale Beach
State/Province
Florida
ZIP/Postal Code
33009
Country
United States
Facility Name
K2 Medical Research ( Site 0057)
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Facility Name
Premier Clinical Research Institute ( Site 0038)
City
Miami
State/Province
Florida
ZIP/Postal Code
33122
Country
United States
Facility Name
Collier Neurologic Specialists ( Site 0045)
City
Naples
State/Province
Florida
ZIP/Postal Code
34105
Country
United States
Facility Name
Atlanta Center for Medical Research ( Site 0044)
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30331
Country
United States
Facility Name
iResearch Atlanta ( Site 0016)
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30030
Country
United States
Facility Name
Alexian Brothers Medical Center ( Site 0011)
City
Elk Grove Village
State/Province
Illinois
ZIP/Postal Code
60007
Country
United States
Facility Name
Tandem Clinical Research ( Site 0055)
City
Marrero
State/Province
Louisiana
ZIP/Postal Code
70072
Country
United States
Facility Name
Global Medical Institutes LLC; Princeton Medical Institute ( Site 0053)
City
Princeton
State/Province
New Jersey
ZIP/Postal Code
08540
Country
United States
Facility Name
Advanced Memory Research Institute of New Jersey ( Site 0027)
City
Toms River
State/Province
New Jersey
ZIP/Postal Code
08755
Country
United States
Facility Name
Richmond Behavioral Associates ( Site 0008)
City
Staten Island
State/Province
New York
ZIP/Postal Code
10314
Country
United States
Facility Name
AMC Research, LLC ( Site 0004)
City
Matthews
State/Province
North Carolina
ZIP/Postal Code
28105
Country
United States
Facility Name
NeuroScience Research Center ( Site 0009)
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
Summit Headlands ( Site 0018)
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Grayline Research Center ( Site 0003)
City
Wichita Falls
State/Province
Texas
ZIP/Postal Code
76309
Country
United States
Facility Name
The Memory Clinic ( Site 0054)
City
Bennington
State/Province
Vermont
ZIP/Postal Code
05201
Country
United States
Facility Name
Re:Cognition Health ( Site 0031)
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Facility Name
Northwest Clinical Research Center ( Site 0056)
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98007
Country
United States
Facility Name
Clinica Privada Banfield ( Site 0205)
City
Banfield
State/Province
Buenos Aires
ZIP/Postal Code
1828
Country
Argentina
Facility Name
Hospital Italiano de Buenos Aires-Geriatrics ( Site 0210)
City
Buenos Aires
State/Province
Caba
ZIP/Postal Code
1181
Country
Argentina
Facility Name
Instituto Kremer ( Site 0202)
City
Córdoba
State/Province
Cordoba
ZIP/Postal Code
X5004AOA
Country
Argentina
Facility Name
IDIM - Instituto de Diagnóstico e Investigaciones Metabólicas ( Site 0204)
City
Buenos Aires
ZIP/Postal Code
1012
Country
Argentina
Facility Name
Instituto Geriatrico Nuestra Señora de Las Nieves ( Site 0208)
City
Buenos Aires
ZIP/Postal Code
C1427CCP
Country
Argentina
Facility Name
Fundación para la Lucha contra las Enfermedades Neurológicas de la Infancia (FLENI) ( Site 0201)
City
Buenos Aires
ZIP/Postal Code
C1428AQK
Country
Argentina
Facility Name
KARA Institute for Neurological Diseases ( Site 1902)
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2113
Country
Australia
Facility Name
Austin Health-Medical & Cognitive Research Unit ( Site 1901)
City
Ivanhoe
State/Province
Victoria
ZIP/Postal Code
3079
Country
Australia
Facility Name
HammondCare ( Site 1903)
City
Malvern
State/Province
Victoria
ZIP/Postal Code
3144
Country
Australia
Facility Name
OCT Research ULC ( Site 0113)
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1Y 1Z9
Country
Canada
Facility Name
Centricity Research - Halifax ( Site 0111)
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3S 1N2
Country
Canada
Facility Name
Ottawa Memory Clinic ( Site 0105)
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Z1G3
Country
Canada
Facility Name
Sunnybrook Health Sciences Centre ( Site 0106)
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
Toronto Western Hospital-Memory clinic ( Site 0102)
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 2S8
Country
Canada
Facility Name
Clinique de la Mémoire de l'Outaouais ( Site 0114)
City
Gatineau
State/Province
Quebec
ZIP/Postal Code
J8T 8J1
Country
Canada
Facility Name
Instituto Neurológico de Colombia ( Site 0415)
City
Medellin
State/Province
Antioquia
ZIP/Postal Code
050012
Country
Colombia
Facility Name
Grupo Neurociencias de Antioquia ( Site 0417)
City
Medellin
State/Province
Antioquia
Country
Colombia
Facility Name
Centro de Investigaciones del Sistema Nervioso - Grupo Cisne ( Site 0414)
City
Bogotá
State/Province
Distrito Capital De Bogota
ZIP/Postal Code
111166
Country
Colombia
Facility Name
Fundacion Valle del Lili- CIC ( Site 0418)
City
Cali
State/Province
Valle Del Cauca
ZIP/Postal Code
760032
Country
Colombia
Facility Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore (
City
Roma
State/Province
Lazio
ZIP/Postal Code
00168
Country
Italy
Facility Name
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico-UOSD Malattie Neurodegenerative ( Site 1204
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20122
Country
Italy
Facility Name
Ospedale San Raffaele ( Site 1202)
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20132
Country
Italy
Facility Name
Ospedale San Gerardo-ASST Monza-Dipartimento di Neuroscienze ( Site 1201)
City
Monza
State/Province
Lombardia
ZIP/Postal Code
20900
Country
Italy
Facility Name
Centro S Giovanni Di Dio Fatebenefratelli ( Site 1205)
City
Brescia
ZIP/Postal Code
25125
Country
Italy
Facility Name
Kakigi Cognition and Emotion Clinic of Hope ( Site 2307)
City
Kobe
State/Province
Hyogo
ZIP/Postal Code
657-0825
Country
Japan
Facility Name
Kagawa University Hospital ( Site 2308)
City
Kita-gun
State/Province
Kagawa
ZIP/Postal Code
761-0793
Country
Japan
Facility Name
Kishiro Mental Clinic ( Site 2310)
City
Kawasaki
State/Province
Kanagawa
ZIP/Postal Code
214-0014
Country
Japan
Facility Name
Kawasaki Saiwai Clinic ( Site 2302)
City
Saiwaiku,Kawasaki
State/Province
Kanagawa
ZIP/Postal Code
212-0016
Country
Japan
Facility Name
Nagomi Clinic ( Site 2305)
City
Toyonaka
State/Province
Osaka
ZIP/Postal Code
5600004
Country
Japan
Facility Name
Tokyo Metropolitan Geriatric Hospital ( Site 2301)
City
Itabashi
State/Province
Tokyo
ZIP/Postal Code
173-0015
Country
Japan
Facility Name
Ishikawa Clinic ( Site 2306)
City
Kyoto
ZIP/Postal Code
606-0851
Country
Japan
Facility Name
Himuro Neurology Clinic ( Site 2304)
City
Osaka
ZIP/Postal Code
5340021
Country
Japan
Facility Name
Inha University Hospital ( Site 2104)
City
Incheon
ZIP/Postal Code
22332
Country
Korea, Republic of
Facility Name
Asan Medical Center-Department of Neurology ( Site 2101)
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Samsung Medical Center ( Site 2102)
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Ewha Womans University Seoul Hospital ( Site 2103)
City
Seoul
ZIP/Postal Code
07804
Country
Korea, Republic of
Facility Name
CGM Research Trust ( Site 2001)
City
Christchurch
State/Province
Canterbury
ZIP/Postal Code
8011
Country
New Zealand
Facility Name
Hospital Universitari Mutua Terrassa-Neurology ( Site 1607)
City
Terrassa
State/Province
Barcelona
ZIP/Postal Code
08222
Country
Spain
Facility Name
HOSPITAL CLÍNIC DE BARCELONA ( Site 1609)
City
Barcelona
State/Province
Cataluna
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital de la Santa Creu i Sant Pau ( Site 1603)
City
Barcelona
State/Province
Cataluna
ZIP/Postal Code
08041
Country
Spain
Facility Name
Clinica Universidad de Navarra-Neurology ( Site 1602)
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
Facility Name
Centro de Atención Especializada Oroitu ( Site 1610)
City
Getxo
State/Province
Pais Vasco
ZIP/Postal Code
48993
Country
Spain
Facility Name
Hospital Universitario Doctor Peset-Neurología ( Site 1601)
City
Valencia
State/Province
Valenciana, Comunitat
ZIP/Postal Code
46017
Country
Spain
Facility Name
Fundació ACE ( Site 1604)
City
Barcelona
ZIP/Postal Code
08034
Country
Spain
Facility Name
Hospital Clinico San Carlos ( Site 1608)
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Viamed Montecanal-Neurociencia ( Site 1606)
City
Zaragoza
ZIP/Postal Code
50012
Country
Spain
Facility Name
Brain Health Scotland Life Sciences ( Site 1810)
City
Edinburgh
State/Province
Edinburgh, City Of
ZIP/Postal Code
EH12 9DQ
Country
United Kingdom
Facility Name
Queen Elizabeth University Hospital-Glasgow Clinical Research Facility ( Site 1808)
City
Glasgow
State/Province
Glasgow City
ZIP/Postal Code
G51 4TF
Country
United Kingdom
Facility Name
Re:Cognition Health - London ( Site 1804)
City
London
State/Province
London, City Of
ZIP/Postal Code
W1G 9JF
Country
United Kingdom
Facility Name
Kingshill Research Centre ( Site 1807)
City
Swindon
State/Province
Wiltshire
ZIP/Postal Code
SN3 6BW
Country
United Kingdom
Facility Name
Re:Cognition Health - Birmingham ( Site 1801)
City
Birmingham
ZIP/Postal Code
B16 8LT
Country
United Kingdom
Facility Name
Re:Cognition Health - Plymouth ( Site 1803)
City
Plymouth
ZIP/Postal Code
PL6 8BT
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
IPD Sharing URL
http://engagezone.msd.com/ds_documentation.php
Links:
URL
https://www.merckclinicaltrials.com/
Description
Merck Clinical Trials Information

Learn more about this trial

Efficacy and Safety of MK-1942 as an Adjunct Therapy in Participants With Mild to Moderate Alzheimer's Disease Dementia (MK-1942-008)

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