Clinical trial • Phase II • Neurology
MK-1167 for Alzheimer's disease dementia
Phase II trial of MK-1167 for Alzheimer's disease dementia.
Overview
- Trial Therapeutic Area
- Neurology
- Trial Disease
- Alzheimer's disease dementia
- Trial Stage
- Phase II
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 12-11-2024
- First CTIS Authorization Date
- 18-03-2025
Trial design
Randomised, placebo to mk-1167 (placebo comparator). no dose or schedule for mk-1167 or placebo specified in the available ctis entries.-controlled Phase II trial in Italy, Netherlands, Spain.
- Randomised
- Yes
- Comparator
- Placebo to MK-1167 (placebo comparator). No dose or schedule for MK-1167 or placebo specified in the available CTIS entries.
- Target Sample Size
- 271
- Trial Duration For Participant
- 168
Eligibility
Recruits 271 isVulnerablePopulationSelected: false; the study requires a designated study partner for each participant to provide information on function/behaviour. Informed consent documentation for multiple countries includes legal representative and trial partner forms (e.g. L1_ICF_Main legal representative_NLD_NL_IN-RFI005_for pub; L1_ICF_Main consent files for ITA/NLD/ESP; L1_ICF_FBR consent files), indicating provisions for obtaining consent from a legal representative or trial partner where applicable..
- Vulnerable Population
- isVulnerablePopulationSelected: false; the study requires a designated study partner for each participant to provide information on function/behaviour. Informed consent documentation for multiple countries includes legal representative and trial partner forms (e.g. L1_ICF_Main legal representative_NLD_NL_IN-RFI005_for pub; L1_ICF_Main consent files for ITA/NLD/ESP; L1_ICF_FBR consent files), indicating provisions for obtaining consent from a legal representative or trial partner where applicable.
Inclusion criteria
- {"criterion_text":"-Has mild to moderate Alzheimer’s Disease (AD) dementia (ie, Stage 4 or Stage 5 AD) based on the Alzheimer’s Association Revised Criteria for Diagnosis and Staging of Alzheimer's Disease"}
- {"criterion_text":"-Has a Mini-Mental State Examination (MMSE) score of 12 to 24 (inclusive)"}
- {"criterion_text":"-Is using acetylcholinesterase inhibitors (AChEI) therapy for management of AD dementia"}
- {"criterion_text":"-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
- {"criterion_text":"-Has a known history of stroke or cerebrovascular disease"}
- {"criterion_text":"-Has diagnosis of a clinically relevant central nervous system (CNS) disease other than AD dementia or other condition that negatively impacts cognition or cognitive status chronically"}
- {"criterion_text":"-Has structural brain disease"}
- {"criterion_text":"-Has a history of seizures or epilepsy"}
- {"criterion_text":"-Has any other major CNS trauma, or infections that affect brain function (eg, Human immunodeficiency virus (HIV), syphilis, and/or neurological sequelae of Coronavirus disease caused by severe acute respiratory syndrome coronavirus 2 (COVID-19), including impact on cognition)"}
- {"criterion_text":"-Has major medical illness or unstable medical condition"}
- {"criterion_text":"-Has a history of malignancy"}
- {"criterion_text":"-Resides in a nursing home or assisted care facility with need for direct continuous medical care and nursing supervision (with protocol-specified exceptions)"}
- {"criterion_text":"-Has liver disease, including but not limited to chronic viral hepatitis, nonviral hepatitis, cirrhosis, malignancies, autoimmune liver diseases"}
Endpoints
Primary endpoints
- {"endpoint_text":"-Change From Baseline in the Alzheimer's Disease Assessment Scale-11-item Cognitive Subscale (ADAS-Cog11) Total Score at Week 24","definition_or_measurement_approach":"Change from baseline measured by the ADAS-Cog11 total score at Week 24."}
- {"endpoint_text":"-Number of participants who experience one or more adverse events (AEs)","definition_or_measurement_approach":"Count of participants reporting one or more adverse events during the study period."}
- {"endpoint_text":"-Number of participants who discontinue study intervention due to an AE","definition_or_measurement_approach":"Count of participants who discontinue the study intervention because of one or more adverse events."}
Secondary endpoints
- {"endpoint_text":"-Alzheimer's Disease Cooperative Study Clinical Global Impression of Change (ADCS-CGIC) Overall Score at Week 24","definition_or_measurement_approach":"ADCS-CGIC overall score assessed at Week 24."}
- {"endpoint_text":"-Change From Baseline in The Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL) Total Score at Week 24","definition_or_measurement_approach":"Change from baseline in ADCS-ADL total score measured at Week 24."}
- {"endpoint_text":"-Change From Baseline in the ADAS-Cog11 Total Score at Week 12","definition_or_measurement_approach":"Change from baseline measured by the ADAS-Cog11 total score at Week 12."}
- {"endpoint_text":"-ADCS-CGIC Overall Score at Week 12","definition_or_measurement_approach":"ADCS-CGIC overall score assessed at Week 12."}
- {"endpoint_text":"-Change From Baseline in the ADCS-ADL Total Score at Week 12","definition_or_measurement_approach":"Change from baseline in ADCS-ADL total score measured at Week 12."}
Recruitment
- Registry Or Advocacy Recruitment
- Yes
- Digital Remote Recruitment
- Yes
- Planned Sample Size
- 271
- Recruitment Window Months
- 27
- Consent Approach
- Informed consent obtained using country-specific ICFs. Main consent forms and data privacy forms available for Italy, Netherlands and Spain (e.g. L1_ICF_Main consent files for ITA/NLD/ESP). Legal representative and trial partner consent/information forms are available (e.g. L1_ICF_Main legal representative_NLD, L1_ICF_Main trial partner files, L1_ICF_FBR consent), indicating processes for consent by participant or by legal representative/trial partner where applicable. Documents available in country languages (Italian, Dutch, Spanish) and English versions for recruitment materials/web content.
Methods
- Study website materials (K2_Recruitment Doc Website files exist for multiple countries/languages)
- Posters (K2_Recruitment Doc Poster)
- Brochures (K2_Recruitment Doc Brochure)
- Patient flyer (K2_Recruitment Doc Patient Flyer)
- Study fact sheet (K2_Recruitment Doc Study Fact Sheet_NLD)
- Material items described (pillbox, bag) for recruitment materials (country-specific K2 documents)
- Use of patient organisation as site/partner (Fundacio Ace in Spain)
- Call center and medical services support via Parexel (noted as 'EUB Services (call center and medical services)')
Geography
- Total Number Of Sites
- 17
- Total Number Of Participants
- 79
Italy
- Earliest CTIS Part Ii Submission Date
- 11-03-2025
- Latest Decision Or Authorization Date
- 15-09-2025
- Processing Time Days
- 188
- Number Of Sites
- 5
- Number Of Participants
- 21
Sites
- Site Name
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Department Name
- UOC Medicina Interna Geriatrica
- Contact Person Name
- Francesco Landi
- Contact Person Email
- francesco.landi@policlinicogemelli.it
- Site Name
- Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
- Department Name
- UOSD Malattie Neurodegenerative
- Contact Person Name
- Andrea Arighi
- Contact Person Email
- andrea.arighi@policlinico.mi.it
- Site Name
- Provincia Lombardo Veneta Dell’Ordine Ospedaliero Di San Giovanni Di Dio Fatebenefratelli
- Department Name
- Unità di Neuroimmagine e Epidemiologia Alzheimer
- Contact Person Name
- Samantha Galluzzi
- Contact Person Email
- sgalluzzi@fatebenefratelli.eu
- Site Name
- Ospedale San Raffaele S.r.l.
- Department Name
- UO di Riabilitazione Specialistica Disturbi Cognitivi e Motori
- Contact Person Name
- Sandro Iannaccone
- Contact Person Email
- iannaccone.sandro@hsr.it
- Site Name
- Fondazione IRCCS San Gerardo Dei Tintori
- Department Name
- Dipartimento di Neuroscienze
- Contact Person Name
- Fulvio Da Re
- Contact Person Email
- fulvio.dare@irccs-sangerardo.it
Netherlands
- Earliest CTIS Part Ii Submission Date
- 20-02-2025
- Latest Decision Or Authorization Date
- 08-09-2025
- Processing Time Days
- 200
- Number Of Sites
- 4
- Number Of Participants
- 17
Sites
- Site Name
- Brain Research Center Zwolle B.V.
- Department Name
- Brain Research centrum
- Contact Person Name
- Jort (E.G.B) Vijverberg
- Contact Person Email
- start-up@brainresearchcenter.nl
- Site Name
- Brain Research Center Amsterdam B.V.
- Department Name
- Brain Research centrum
- Contact Person Name
- Jort (E.G.B) Vijverberg
- Contact Person Email
- start-up@brainresearchcenter.nl
- Site Name
- PreCare Trial & Recruitment B.V.
- Department Name
- PT&R BV
- Contact Person Name
- Vivienne van de Walle
- Contact Person Email
- info@ptr.nu
- Site Name
- Brain Research Center Den Bosch B.V.
- Department Name
- Brain Research centrum
- Contact Person Name
- Jort (E.G.B) Vijverberg
- Contact Person Email
- start-up@brainresearchcenter.nl
Spain
- Earliest CTIS Part Ii Submission Date
- 03-02-2025
- Latest Decision Or Authorization Date
- 15-09-2025
- Processing Time Days
- 224
- Number Of Sites
- 8
- Number Of Participants
- 41
Sites
- Site Name
- Oroitu S.L.
- Department Name
- Neurology
- Contact Person Name
- Manuel Fernandez Martinez
- Contact Person Email
- centrocaeoroitu@oroitu.com
- Site Name
- Hospital Universitario Virgen De La Macarena
- Department Name
- Neurology
- Contact Person Name
- Felix Viñuela Fernandez
- Contact Person Email
- fvinuela@us.es
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- Neurology
- Contact Person Name
- Alberto Villarejo Galende
- Contact Person Email
- alberto.villarejo@salud.madrid.org
- Site Name
- Hospital Universitario Y Politecnico La Fe
- Department Name
- Neurology
- Contact Person Name
- Miquel Baquero Toledo
- Contact Person Email
- baquero_miq@gva.es
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Neurology
- Contact Person Name
- Maria Pilar Delgado Martinez
- Contact Person Email
- mpilar.delgado@vallhebron.cat
- Site Name
- Fundacio Ace Institut Catala De Neurociencies Aplicades
- Department Name
- Neurology
- Contact Person Name
- Juan Pablo Tartari Diaz Zorita
- Contact Person Email
- jptartari@fundacioace.org
- Site Name
- Hospital De La Santa Creu I Sant Pau
- Department Name
- Neurology
- Contact Person Name
- Juan Fortea Ormaechea
- Contact Person Email
- jforteaac@santpau.cat
- Site Name
- Additional Spanish site (listed in Part II)
- Department Name
- Neurology
Sponsor
Primary sponsor
- Full Name
- Merck Sharp & Dohme LLC
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Contract research organisations
- Name
- Parexel International Corp.
- Responsibilities
- EUB Services (call center and medical services)
- Name
- Fortrea Inc.
- Responsibilities
- code: 1
- Name
- Almac Clinical Services LLC
- Responsibilities
- code: 3
- Name
- Bioclinica Inc.
- Responsibilities
- MRI Vendor / ECG Vendor
- Name
- WCG Clinical Inc.
- Responsibilities
- ECOA and Rater Training
- Name
- Labcorp Central Laboratory Services SARL
- Responsibilities
- central laboratory services (code: 4)
Third parties
- {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"code: 4","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Parexel International Corp.","duties_or_roles":"EUB Services (call center and medical services)","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"MRI Vendor","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Fortrea Inc.","duties_or_roles":"code: 1","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Almac Clinical Services LLC","duties_or_roles":"code: 3","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"ECG Vendor","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"WCG Clinical Inc.","duties_or_roles":"ECOA and Rater Training","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- MK-1167
- Active Substance
- MK-1167
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- Authorized
- Investigational Product Name
- Placebo to MK-1167
- Modality
- Other
- Combination Treatment
- Yes
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