Clinical trial NCT05602727: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Alzheimer's Disease
Keywords: Alzheimer's Disease
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2022-11-02
Enrollment: 99
Sex: ALL
Minimum age (years): 55
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: Change From Baseline in the Alzheimer's Disease Assessment Scale-11-item Cognitive Subscale (ADAS-Cog11) Score at Week 12
timeFrame: Baseline and Week 12
measure: Number of Participants Experiencing an Adverse Event (AE)
timeFrame: Up to ~ 14 Weeks
measure: Number of Participants Discontinuing Study Medication Due to an Adverse Event
timeFrame: Up to ~ 12 Weeks
Secondary outcomes:
measure: Alzheimer's Disease Cooperative Study Clinical Global Impression of Change (ADCS-CGIC) Overall Score at Week 12
timeFrame: Week 12
measure: Mean Change From Baseline in The Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL) Total Score at Week 12
timeFrame: Baseline and Week 12
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Banner Alzheimer's Institute ( Site 0017)
state: Arizona
city: Fullerton
country: United States
facility: Neurology Center of North Orange County ( Site 0039)
state: California
city: Sherman Oaks
country: United States
facility: California Neuroscience Research, LLC ( Site 0058)
state: California
city: Atlantis
country: United States
facility: JEM Research Institute ( Site 0013)
state: Florida
city: Hallandale Beach
country: United States
facility: Velocity Clinical Research, Hallandale Beach ( Site 0025)
state: Florida
city: Maitland
country: United States
facility: K2 Medical Research ( Site 0057)
state: Florida
city: Miami
country: United States
facility: Premier Clinical Research Institute ( Site 0038)
state: Florida
city: Naples
country: United States
facility: Collier Neurologic Specialists ( Site 0045)
state: Florida
city: Atlanta
country: United States
facility: Atlanta Center for Medical Research ( Site 0044)
state: Georgia
city: Decatur
country: United States
facility: iResearch Atlanta ( Site 0016)
state: Georgia
city: Elk Grove Village
country: United States
facility: Alexian Brothers Medical Center ( Site 0011)
state: Illinois
city: Marrero
country: United States
facility: Tandem Clinical Research ( Site 0055)
state: Louisiana
city: Princeton
country: United States
facility: Global Medical Institutes LLC; Princeton Medical Institute ( Site 0053)
state: New Jersey
city: Toms River
country: United States
facility: Advanced Memory Research Institute of New Jersey ( Site 0027)
state: New Jersey
city: Staten Island
country: United States
facility: Richmond Behavioral Associates ( Site 0008)
state: New York
city: Matthews
country: United States
facility: AMC Research, LLC ( Site 0004)
state: North Carolina
city: Canton
country: United States
facility: NeuroScience Research Center ( Site 0009)
state: Ohio
city: Portland
country: United States
facility: Summit Headlands ( Site 0018)
state: Oregon
city: Wichita Falls
country: United States
facility: Grayline Research Center ( Site 0003)
state: Texas
city: Bennington
country: United States
facility: The Memory Clinic ( Site 0054)
state: Vermont
city: Fairfax
country: United States
facility: Re:Cognition Health ( Site 0031)
state: Virginia
city: Bellevue
country: United States
facility: Northwest Clinical Research Center ( Site 0056)
state: Washington
city: Banfield
country: Argentina
facility: Clinica Privada Banfield ( Site 0205)
state: Buenos Aires
city: Buenos Aires
country: Argentina
facility: Hospital Italiano de Buenos Aires-Geriatrics ( Site 0210)
state: Caba
city: Córdoba
country: Argentina
facility: Instituto Kremer ( Site 0202)
state: Cordoba
city: Buenos Aires
country: Argentina
facility: IDIM - Instituto de Diagnóstico e Investigaciones Metabólicas ( Site 0204)
city: Buenos Aires
country: Argentina
facility: Instituto Geriatrico Nuestra Señora de Las Nieves ( Site 0208)
city: Buenos Aires
country: Argentina
facility: Fundación para la Lucha contra las Enfermedades Neurológicas de la Infancia (FLENI) ( Site 0201)
city: Sydney
country: Australia
facility: KARA Institute for Neurological Diseases ( Site 1902)
state: New South Wales
city: Ivanhoe
country: Australia
facility: Austin Health-Medical & Cognitive Research Unit ( Site 1901)
state: Victoria
city: Malvern
country: Australia
facility: HammondCare ( Site 1903)
state: Victoria
city: Kelowna
country: Canada
facility: OCT Research ULC ( Site 0113)
state: British Columbia
city: Halifax
country: Canada
facility: Centricity Research - Halifax ( Site 0111)
state: Nova Scotia
city: Ottawa
country: Canada
facility: Ottawa Memory Clinic ( Site 0105)
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre ( Site 0106)
state: Ontario
city: Toronto
country: Canada
facility: Toronto Western Hospital-Memory clinic ( Site 0102)
state: Ontario
city: Gatineau
country: Canada
facility: Clinique de la Mémoire de l'Outaouais ( Site 0114)
state: Quebec
city: Medellin
country: Colombia
facility: Instituto Neurológico de Colombia ( Site 0415)
state: Antioquia
city: Medellin
country: Colombia
facility: Grupo Neurociencias de Antioquia ( Site 0417)
state: Antioquia
city: Bogotá
country: Colombia
facility: Centro de Investigaciones del Sistema Nervioso - Grupo Cisne ( Site 0414)
state: Distrito Capital De Bogota
city: Cali
country: Colombia
facility: Fundacion Valle del Lili- CIC ( Site 0418)
state: Valle Del Cauca
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore (
state: Lazio
city: Milano
country: Italy
facility: Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico-UOSD Malattie Neurodegenerative ( Site 1204
state: Lombardia
city: Milano
country: Italy
facility: Ospedale San Raffaele ( Site 1202)
state: Lombardia
city: Monza
country: Italy
facility: Ospedale San Gerardo-ASST Monza-Dipartimento di Neuroscienze ( Site 1201)
state: Lombardia
city: Brescia
country: Italy
facility: Centro S Giovanni Di Dio Fatebenefratelli ( Site 1205)
city: Kobe
country: Japan
facility: Kakigi Cognition and Emotion Clinic of Hope ( Site 2307)
state: Hyogo
city: Kita-gun
country: Japan
facility: Kagawa University Hospital ( Site 2308)
state: Kagawa
city: Kawasaki
country: Japan
facility: Kishiro Mental Clinic ( Site 2310)
state: Kanagawa
city: Saiwaiku,Kawasaki
country: Japan
facility: Kawasaki Saiwai Clinic ( Site 2302)
state: Kanagawa
city: Toyonaka
country: Japan
facility: Nagomi Clinic ( Site 2305)
state: Osaka
city: Itabashi
country: Japan
facility: Tokyo Metropolitan Geriatric Hospital ( Site 2301)
state: Tokyo
city: Kyoto
country: Japan
facility: Ishikawa Clinic ( Site 2306)
city: Osaka
country: Japan
facility: Himuro Neurology Clinic ( Site 2304)
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital ( Site 2104)
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center-Department of Neurology ( Site 2101)
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center ( Site 2102)
city: Seoul
country: Korea, Republic of
facility: Ewha Womans University Seoul Hospital ( Site 2103)
city: Christchurch
country: New Zealand
facility: CGM Research Trust ( Site 2001)
state: Canterbury
city: Terrassa
country: Spain
facility: Hospital Universitari Mutua Terrassa-Neurology ( Site 1607)
state: Barcelona
city: Barcelona
country: Spain
facility: HOSPITAL CLÍNIC DE BARCELONA ( Site 1609)
state: Cataluna
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau ( Site 1603)
state: Cataluna
city: Pamplona
country: Spain
facility: Clinica Universidad de Navarra-Neurology ( Site 1602)
state: Navarra
city: Getxo
country: Spain
facility: Centro de Atención Especializada Oroitu ( Site 1610)
state: Pais Vasco
city: Valencia
country: Spain
facility: Hospital Universitario Doctor Peset-Neurología ( Site 1601)
state: Valenciana, Comunitat
city: Barcelona
country: Spain
facility: Fundació ACE ( Site 1604)
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos ( Site 1608)
city: Zaragoza
country: Spain
facility: Hospital Viamed Montecanal-Neurociencia ( Site 1606)
city: Edinburgh
country: United Kingdom
facility: Brain Health Scotland Life Sciences ( Site 1810)
state: Edinburgh, City Of
city: Glasgow
country: United Kingdom
facility: Queen Elizabeth University Hospital-Glasgow Clinical Research Facility ( Site 1808)
state: Glasgow City
city: London
country: United Kingdom
facility: Re:Cognition Health - London ( Site 1804)
state: London, City Of
city: Swindon
country: United Kingdom
facility: Kingshill Research Centre ( Site 1807)
state: Wiltshire
city: Birmingham
country: United Kingdom
facility: Re:Cognition Health - Birmingham ( Site 1801)
city: Plymouth
country: United Kingdom
facility: Re:Cognition Health - Plymouth ( Site 1803)
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: