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Alzheimer's DiseasePhase 2NCT05602727

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

A Phase 2 study testing MK-1942 in people with Alzheimer's Disease, run by Merck Sharp & Dohme LLC at 74 sites in 11 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 55 to 90 years
Conditions the study is for
Alzheimer's Disease
What is being tested?
MK-1942
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
99 participants
Where
74 sitesin 11 countries
Study dates
2 Dec 2022to 27 Sep 2023
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 55 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 15Show fewer
  • 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.

Trial locations and contacts

74 sites in 11 countries.

74 sites in 11 countries

United States22 sites

  • Atlanta Center for Medical Research ( Site 0044)

    Atlanta, Georgia, 30331

  • JEM Research Institute ( Site 0013)

    Atlantis, Florida, 33462

  • Northwest Clinical Research Center ( Site 0056)

    Bellevue, Washington, 98007

  • The Memory Clinic ( Site 0054)

    Bennington, Vermont, 05201

  • NeuroScience Research Center ( Site 0009)

    Canton, Ohio, 44718

  • iResearch Atlanta ( Site 0016)

    Decatur, Georgia, 30030

  • Alexian Brothers Medical Center ( Site 0011)

    Elk Grove Village, Illinois, 60007

  • Re:Cognition Health ( Site 0031)

    Fairfax, Virginia, 22031

  • Neurology Center of North Orange County ( Site 0039)

    Fullerton, California, 92835

  • Velocity Clinical Research, Hallandale Beach ( Site 0025)

    Hallandale, Florida, 33009

  • K2 Medical Research ( Site 0057)

    Maitland, Florida, 32751

  • Tandem Clinical Research ( Site 0055)

    Marrero, Louisiana, 70072

  • AMC Research, LLC ( Site 0004)

    Matthews, North Carolina, 28105

  • Premier Clinical Research Institute ( Site 0038)

    Miami, Florida, 33122

  • Collier Neurologic Specialists ( Site 0045)

    Naples, Florida, 34105

  • Banner Alzheimer's Institute ( Site 0017)

    Phoenix, Arizona, 85006

  • Summit Headlands ( Site 0018)

    Portland, Oregon, 97210

  • Global Medical Institutes LLC; Princeton Medical Institute ( Site 0053)

    Princeton, New Jersey, 08540

  • California Neuroscience Research, LLC ( Site 0058)

    Sherman Oaks, California, 91403

  • Richmond Behavioral Associates ( Site 0008)

    Staten Island, New York, 10314

  • Advanced Memory Research Institute of New Jersey ( Site 0027)

    Toms River, New Jersey, 08755

  • Grayline Research Center ( Site 0003)

    Wichita Falls, Texas, 76309

Other trials in United States

Spain9 sites

  • HOSPITAL CLÍNIC DE BARCELONA ( Site 1609)

    Barcelona, Catalonia, 08036

  • Hospital de la Santa Creu i Sant Pau ( Site 1603)

    Barcelona, Catalonia, 08041

  • Fundació ACE ( Site 1604)

    Barcelona, 08034

  • Centro de Atención Especializada Oroitu ( Site 1610)

    Getxo, Basque Country, 48993

  • Hospital Clinico San Carlos ( Site 1608)

    Madrid, 28040

  • Clinica Universidad de Navarra-Neurology ( Site 1602)

    Pamplona, Navarre, 31008

  • Hospital Universitari Mutua Terrassa-Neurology ( Site 1607)

    Terrassa, Barcelona, 08222

  • Hospital Universitario Doctor Peset-Neurología ( Site 1601)

    Valencia, Valenciana, Comunitat, 46017

  • Hospital Viamed Montecanal-Neurociencia ( Site 1606)

    Zaragoza, 50012

Other trials in Spain

Japan8 sites

  • Kishiro Mental Clinic ( Site 2310)

    Kawasaki, Kanagawa, 214-0014

  • Kagawa University Hospital ( Site 2308)

    Kita-gun, Kagawa-ken, 761-0793

  • Kakigi Cognition and Emotion Clinic of Hope ( Site 2307)

    Kobe, Hyōgo, 657-0825

  • Ishikawa Clinic ( Site 2306)

    Kyoto, 606-0851

  • Himuro Neurology Clinic ( Site 2304)

    Osaka, 5340021

  • Kawasaki Saiwai Clinic ( Site 2302)

    Saiwaiku,Kawasaki, Kanagawa, 212-0016

  • Tokyo Metropolitan Geriatric Hospital ( Site 2301)

    tabashi City, Tokyo, 173-0015

  • Nagomi Clinic ( Site 2305)

    Toyonaka, Osaka, 5600004

Other trials in Japan

Argentina6 sites

  • Clinica Privada Banfield ( Site 0205)

    Banfield, Buenos Aires, 1828

  • Hospital Italiano de Buenos Aires-Geriatrics ( Site 0210)

    Buenos Aires, Buenos Aires F.D., 1181

  • IDIM - Instituto de Diagnóstico e Investigaciones Metabólicas ( Site 0204)

    Buenos Aires, 1012

  • Instituto Geriatrico Nuestra Señora de Las Nieves ( Site 0208)

    Buenos Aires, C1427CCP

  • Fundación para la Lucha contra las Enfermedades Neurológicas de la Infancia (FLENI) ( Site 0201)

    Buenos Aires, C1428AQK

  • Instituto Kremer ( Site 0202)

    Córdoba, Córdoba Province, X5004AOA

Other trials in Argentina

Canada6 sites

  • Clinique de la Mémoire de l'Outaouais ( Site 0114)

    Gatineau, Quebec, J8T 8J1

  • Centricity Research - Halifax ( Site 0111)

    Halifax, Nova Scotia, B3S 1N2

  • OCT Research ULC ( Site 0113)

    Kelowna, British Columbia, V1Y 1Z9

  • Ottawa Memory Clinic ( Site 0105)

    Ottawa, Ontario, K1Z1G3

  • Sunnybrook Health Sciences Centre ( Site 0106)

    Toronto, Ontario, M4N 3M5

  • Toronto Western Hospital-Memory clinic ( Site 0102)

    Toronto, Ontario, M5T 2S8

Other trials in Canada

United Kingdom6 sites

  • Re:Cognition Health - Birmingham ( Site 1801)

    Birmingham, B16 8LT

  • Brain Health Scotland Life Sciences ( Site 1810)

    Edinburgh, Edinburgh, City of, EH12 9DQ

  • Queen Elizabeth University Hospital-Glasgow Clinical Research Facility ( Site 1808)

    Glasgow, Glasgow City, G51 4TF

  • Re:Cognition Health - London ( Site 1804)

    London, London, City of, W1G 9JF

  • Re:Cognition Health - Plymouth ( Site 1803)

    Plymouth, PL6 8BT

  • Kingshill Research Centre ( Site 1807)

    Swindon, Wiltshire, SN3 6BW

Other trials in United Kingdom

Italy5 sites

  • Centro S Giovanni Di Dio Fatebenefratelli ( Site 1205)

    Brescia, 25125

  • Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico-UOSD Malattie Neurodegenerative ( Site 1204

    Milan, Lombardy, 20122

  • Ospedale San Raffaele ( Site 1202)

    Milan, Lombardy, 20132

  • Ospedale San Gerardo-ASST Monza-Dipartimento di Neuroscienze ( Site 1201)

    Monza, Lombardy, 20900

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore (

    Rome, Lazio, 00168

Other trials in Italy

Colombia4 sites

  • Centro de Investigaciones del Sistema Nervioso - Grupo Cisne ( Site 0414)

    Bogotá, Bogota D.C., 111166

  • Fundacion Valle del Lili- CIC ( Site 0418)

    Cali, Valle del Cauca Department, 760032

  • Instituto Neurológico de Colombia ( Site 0415)

    Medellín, Antioquia, 050012

  • Grupo Neurociencias de Antioquia ( Site 0417)

    Medellín, Antioquia

Other trials in Colombia

South Korea4 sites

  • Inha University Hospital ( Site 2104)

    Incheon, 22332

  • Asan Medical Center-Department of Neurology ( Site 2101)

    Seoul, 05505

  • Samsung Medical Center ( Site 2102)

    Seoul, 06351

  • Ewha Womans University Seoul Hospital ( Site 2103)

    Seoul, 07804

Other trials in South Korea

Australia3 sites

  • Austin Health-Medical & Cognitive Research Unit ( Site 1901)

    Ivanhoe, Victoria, 3079

  • HammondCare ( Site 1903)

    Malvern, Victoria, 3144

  • KARA Institute for Neurological Diseases ( Site 1902)

    Sydney, New South Wales, 2113

Other trials in Australia

New Zealand1 site

  • CGM Research Trust ( Site 2001)

    Christchurch, Canterbury, 8011

Other trials in New Zealand

About this study

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

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.

Being tested
MK-1942, Placebo
Keywords
Alzheimer's Disease
Medical subject headings
Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MK-1942Drug

    MK-1942 oral capsule

  • PlaceboDrug

    Placebo oral capsule

Study groups in NCT05602727
Study groupRoleWhat they receive
MK-1942 5 mgExperimentalParticipants 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.
Receives: Drug: MK-1942
MK-1942 15 mgExperimentalParticipants 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.
Receives: Drug: MK-1942
PlaceboPlacebo comparatorParticipants 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.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline in the Alzheimer's Disease Assessment Scale-11-item Cognitive Subscale (ADAS-Cog11) Score at Week 12

    The change from baseline in ADAS-Cog11 score is presented. 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. The total possible score ranges from 0 to 70, with higher scores indicating greater cognitive impairment. Negative values indicate improvement relative to baseline, and vice versa.

    Measured: Baseline and Week 12

  2. 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. 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.

    Measured: Up to ~ 14 Weeks

  3. 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.

    Measured: Up to ~ 12 Weeks

Secondary outcomes (2)

  1. Alzheimer's Disease Cooperative Study Clinical Global Impression of Change (ADCS-CGIC) Overall Score at Week 12

    The overall score in ADCS-CGIC is presented. ADCS-CGIC is a global scale assessing cognition and function based on structured interviews of both the participant and study partner. 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.

    Measured: Week 12

  2. Mean Change From Baseline in The Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL) Total Score at Week 12

    The change from baseline in ADCS-ADL score is presented. The ADCS-ADL is an informant-based measure of the participant's functional ability in activities of daily living. 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 items and 17 instrumental ADL items that provide a total score ranging from 0 to 78, with a lower score indicating greater severity.

    Measured: Baseline and Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Nov 2022
  2. Study start2 Dec 2022
  3. Primary completion27 Sep 2023
  4. Study completion27 Sep 2023

Why it stopped: Voluntarily terminated due to benefit/risk assessment

Resources

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
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
99 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05602727
Sponsor's protocol ID
1942-008
Other IDs
MK-1942-008, jRCT2031220532, 2021-006336-94
Status last verified
Dec 2024
First submitted
27 Oct 2022
Last updated
10 Dec 2024
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing MK-1942 in people with Alzheimer's Disease, run by Merck Sharp & Dohme LLC at 74 sites in 11 countries.

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 4 inclusion and 15 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: stopped early, as of the sponsor's last update on 10 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 74 sites in United States, Spain, Japan, Argentina, Canada and 6 more countries. 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?

Yes. Results are posted in the registry (first posted 15 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in the Alzheimer's Disease Assessment Scale-11-item Cognitive Subscale (ADAS-Cog11) Score at Week 12 (time frame: Baseline and Week 12). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05602727.

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 10 Dec 2024.

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