TerminatedNCT05602727Updated Dec 10, 2024Results posted

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 interventional study of MK-1942 and Placebo in Alzheimer's Disease, sponsored by Merck Sharp & Dohme LLC. Terminated at 74 sites in 11 countries. Open to participants aged 55 Years to 90 Years. Per ClinicalTrials.gov, last updated 2024-12-10.

Sponsored by Merck Sharp & Dohme LLC · Phase 2, Interventional, and Treatment

Why this study was terminated

Voluntarily terminated due to benefit/risk assessment

Phase: Phase 2
Study type: Interventional
Enrollment: 99
Allocation: Randomized
Ages: 55 Years to 90 Years
Sex: All

Study 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.

Conditions studied

Alzheimer's Disease

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Keywords

Alzheimer's Disease

In context

Alzheimer Disease

3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.

This study's enrollment of 99 is above the median of 70 across 2,808 interventional studies indexed under Alzheimer Disease.

Browse Alzheimer Disease studies →

Lead sponsor

Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 133 are open to participants now.

Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 55 Years to 90 Years
Sexes eligible: All
Accepts healthy volunteers: No

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

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

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Triple (Participant, Investigator, Outcomes assessor)
Enrollment: 99 participants (actual)

Study arms

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.
Drug: MK-1942
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.
Drug: MK-1942
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.
Drug: Placebo

Interventions

DrugMK-1942
MK-1942 oral capsule
DrugPlacebo
Placebo oral capsule

What researchers measure

Primary outcomes

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.
Time frame: Baseline and Week 12
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.
Time frame: Up to ~ 14 Weeks
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.
Time frame: Up to ~ 12 Weeks

Secondary outcomes

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.
Time frame: Week 12
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.
Time frame: Baseline and Week 12

Results

Posted Oct 15, 2024

Participant flow

Participant flow — Overall Study
Milestone	MK-1942 5 mg	MK-1942 15 mg	Placebo
Started	35	31	33
Completed	13	8	12
Not completed	22	23	21
Withdrew: Physician decision	0	1	0
Withdrew: Randomized by mistake without study medication	1	0	0
Withdrew: Study termination by sponsor	18	15	19
Withdrew: Withdrawal by subject	2	1	1
Withdrew: Various reasons	1	6	1

Outcome measures

PrimaryChange 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.

Time frame:: Baseline and Week 12
Reported as:: Least squares mean · Units on a scale

Change From Baseline in the Alzheimer's Disease Assessment Scale-11-item Cognitive Subscale (ADAS-Cog11) Score at Week 12
Units on a scale	MK-1942 5 mg	MK-1942 15 mg	Placebo
Change From Baseline in the Alzheimer's Disease Assessment Scale-11-item Cognitive Subscale (ADAS-Cog11) Score at Week 12	2.9 (0.7 to 5.1)	-0.6 (-3.0 to 1.8)	0.8 (-1.4 to 3.0)

Statistical analysis

MK-1942 5 mg vs Placebo · Longitudinal ANCOVA · p = 0.186 · Ls mean difference: 2.1 · 97.5% CI -1.6 to 5.8
MK-1942 15 mg vs Placebo · Longitudinal ANCOVA · p = 0.400 · Ls mean difference: -1.4 · 97.5% CI -5.2 to 2.4

PrimaryNumber 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.

Time frame:: Up to ~ 14 Weeks
Reported as:: Count of participants · Participants

Number of Participants Experiencing an Adverse Event (AE)
Participants	MK-1942 5 mg	MK-1942 15 mg	Placebo
Number of Participants Experiencing an Adverse Event (AE)	17	21	18

PrimaryNumber of Participants Discontinuing Study Medication Due to an Adverse Event

Time frame:: Up to ~ 12 Weeks
Reported as:: Count of participants · Participants

Number of Participants Discontinuing Study Medication Due to an Adverse Event
Participants	MK-1942 5 mg	MK-1942 15 mg	Placebo
Number of Participants Discontinuing Study Medication Due to an Adverse Event	4	6	3

SecondaryAlzheimer'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.

Time frame:: Week 12
Reported as:: Mean · Units on a scale

Alzheimer's Disease Cooperative Study Clinical Global Impression of Change (ADCS-CGIC) Overall Score at Week 12
Units on a scale	MK-1942 5 mg	MK-1942 15 mg	Placebo
Alzheimer's Disease Cooperative Study Clinical Global Impression of Change (ADCS-CGIC) Overall Score at Week 12	5.4 ± 0.7	5.8 ± 0.9	5.3 ± 0.8

SecondaryMean 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.

Time frame:: Baseline and Week 12
Reported as:: Least squares mean · Units on a scale

Mean Change From Baseline in The Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL) Total Score at Week 12
Units on a scale	MK-1942 5 mg	MK-1942 15 mg	Placebo
Mean Change From Baseline in The Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL) Total Score at Week 12	-1.7 (-4.8 to 1.4)	-3.0 (-6.4 to 0.4)	1.2 (-2.0 to 4.4)

Statistical analysis

MK-1942 5 mg vs Placebo · Longitudinal ANCOVA · p = 0.196 · Ls mean difference: -2.9 · 97.5% CI -8.0 to 2.2
MK-1942 15 mg vs Placebo · Longitudinal ANCOVA · p = 0.081 · Ls mean difference: -4.2 · 97.5% CI -9.6 to 1.3

Adverse events

Collected over Up to ~14 weeks. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
MK-1942 5 mg	0/34 (0%)	1/34 (2.9%)	16/34 (47.1%)
MK-1942 15 mg	0/31 (0%)	2/31 (6.5%)	16/31 (51.6%)
Placebo	0/33 (0%)	2/33 (6.1%)	12/33 (36.4%)

Most frequent serious events

Most frequent serious events
Event	MK-1942 5 mg	MK-1942 15 mg	Placebo
Chest painGeneral disorders	0/34	1/31	0/33
FallInjury, poisoning and procedural complications	0/34	1/31	0/33
BradycardiaCardiac disorders	0/34	0/31	1/33
AstheniaGeneral disorders	0/34	0/31	1/33
SyncopeNervous system disorders	0/34	0/31	1/33
HemiparesisNervous system disorders	1/34	0/31	0/33

Most frequent other events

Showing 10 of 15

Most frequent other events
Event	MK-1942 5 mg	MK-1942 15 mg	Placebo
Alanine aminotransferase increasedInvestigations	10/34	5/31	1/33
NauseaGastrointestinal disorders	1/34	5/31	0/33
DizzinessNervous system disorders	4/34	5/31	4/33
FallInjury, poisoning and procedural complications	3/34	0/31	4/33
VomitingGastrointestinal disorders	1/34	3/31	1/33
DiarrhoeaGastrointestinal disorders	3/34	0/31	0/33
HeadacheNervous system disorders	3/34	1/31	1/33
FatigueGeneral disorders	1/34	2/31	1/33
Accidental overdoseInjury, poisoning and procedural complications	0/34	2/31	0/33
Aspartate aminotransferase increasedInvestigations	1/34	2/31	1/33

Baseline characteristics

Age, Continuous
Age, Continuous(Years)	MK-1942 5 mg	MK-1942 15 mg	Placebo	Total
Mean	74.1 ± 7.5	74.7 ± 8.0	72.3 ± 8.2	73.7 ± 7.9

Sex: Female, Male
Sex: Female, Male(Participants)	MK-1942 5 mg	MK-1942 15 mg	Placebo	Total
Female	25	21	23	69
Male	10	10	10	30

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	MK-1942 5 mg	MK-1942 15 mg	Placebo	Total
Hispanic or Latino	2	6	2	10
Not Hispanic or Latino	33	25	31	89
Unknown or Not Reported	0	0	0	0

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	MK-1942 5 mg	MK-1942 15 mg	Placebo	Total
American Indian or Alaska Native	0	0	0	0
Asian	6	3	6	15
Native Hawaiian or Other Pacific Islander	0	0	0	0
Black or African American	0	0	1	1
White	29	28	26	83
More than one race	0	0	0	0
Unknown or Not Reported	0	0	0	0

Study locations

74 sites

Banner Alzheimer's Institute ( Site 0017)
Phoenix, Arizona 85006, United States
Neurology Center of North Orange County ( Site 0039)
Fullerton, California 92835, United States
California Neuroscience Research, LLC ( Site 0058)
Sherman Oaks, California 91403, United States
JEM Research Institute ( Site 0013)
Atlantis, Florida 33462, United States
Velocity Clinical Research, Hallandale Beach ( Site 0025)
Hallandale Beach, Florida 33009, United States
K2 Medical Research ( Site 0057)
Maitland, Florida 32751, United States
Premier Clinical Research Institute ( Site 0038)
Miami, Florida 33122, United States
Collier Neurologic Specialists ( Site 0045)
Naples, Florida 34105, United States
Atlanta Center for Medical Research ( Site 0044)
Atlanta, Georgia 30331, United States
iResearch Atlanta ( Site 0016)
Decatur, Georgia 30030, United States
Alexian Brothers Medical Center ( Site 0011)
Elk Grove Village, Illinois 60007, United States
Tandem Clinical Research ( Site 0055)
Marrero, Louisiana 70072, United States
Global Medical Institutes LLC; Princeton Medical Institute ( Site 0053)
Princeton, New Jersey 08540, United States
Advanced Memory Research Institute of New Jersey ( Site 0027)
Toms River, New Jersey 08755, United States
Richmond Behavioral Associates ( Site 0008)
Staten Island, New York 10314, United States
AMC Research, LLC ( Site 0004)
Matthews, North Carolina 28105, United States
NeuroScience Research Center ( Site 0009)
Canton, Ohio 44718, United States
Summit Headlands ( Site 0018)
Portland, Oregon 97210, United States
Grayline Research Center ( Site 0003)
Wichita Falls, Texas 76309, United States
The Memory Clinic ( Site 0054)
Bennington, Vermont 05201, United States
Re:Cognition Health ( Site 0031)
Fairfax, Virginia 22031, United States
Northwest Clinical Research Center ( Site 0056)
Bellevue, Washington 98007, United States
Clinica Privada Banfield ( Site 0205)
Banfield, Buenos Aires 1828, Argentina
Hospital Italiano de Buenos Aires-Geriatrics ( Site 0210)
Buenos Aires, Caba 1181, Argentina
Instituto Kremer ( Site 0202)
Córdoba, Cordoba X5004AOA, Argentina
IDIM - Instituto de Diagnóstico e Investigaciones Metabólicas ( Site 0204)
Buenos Aires, 1012, Argentina
Instituto Geriatrico Nuestra Señora de Las Nieves ( Site 0208)
Buenos Aires, C1427CCP, Argentina
Fundación para la Lucha contra las Enfermedades Neurológicas de la Infancia (FLENI) ( Site 0201)
Buenos Aires, C1428AQK, Argentina
KARA Institute for Neurological Diseases ( Site 1902)
Sydney, New South Wales 2113, Australia
Austin Health-Medical & Cognitive Research Unit ( Site 1901)
Ivanhoe, Victoria 3079, Australia
HammondCare ( Site 1903)
Malvern, Victoria 3144, Australia
OCT Research ULC ( Site 0113)
Kelowna, British Columbia V1Y 1Z9, Canada
Centricity Research - Halifax ( Site 0111)
Halifax, Nova Scotia B3S 1N2, Canada
Ottawa Memory Clinic ( Site 0105)
Ottawa, Ontario K1Z1G3, Canada
Sunnybrook Health Sciences Centre ( Site 0106)
Toronto, Ontario M4N 3M5, Canada
Toronto Western Hospital-Memory clinic ( Site 0102)
Toronto, Ontario M5T 2S8, Canada
Clinique de la Mémoire de l'Outaouais ( Site 0114)
Gatineau, Quebec J8T 8J1, Canada
Instituto Neurológico de Colombia ( Site 0415)
Medellin, Antioquia 050012, Colombia
Grupo Neurociencias de Antioquia ( Site 0417)
Medellin, Antioquia, Colombia
Centro de Investigaciones del Sistema Nervioso - Grupo Cisne ( Site 0414)
Bogotá, Distrito Capital De Bogota 111166, Colombia
Fundacion Valle del Lili- CIC ( Site 0418)
Cali, Valle Del Cauca 760032, Colombia
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore (
Roma, Lazio 00168, Italy
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico-UOSD Malattie Neurodegenerative ( Site 1204
Milano, Lombardia 20122, Italy
Ospedale San Raffaele ( Site 1202)
Milano, Lombardia 20132, Italy
Ospedale San Gerardo-ASST Monza-Dipartimento di Neuroscienze ( Site 1201)
Monza, Lombardia 20900, Italy
Centro S Giovanni Di Dio Fatebenefratelli ( Site 1205)
Brescia, 25125, Italy
Kakigi Cognition and Emotion Clinic of Hope ( Site 2307)
Kobe, Hyogo 657-0825, Japan
Kagawa University Hospital ( Site 2308)
Kita-gun, Kagawa 761-0793, Japan
Kishiro Mental Clinic ( Site 2310)
Kawasaki, Kanagawa 214-0014, Japan
Kawasaki Saiwai Clinic ( Site 2302)
Saiwaiku,Kawasaki, Kanagawa 212-0016, Japan
Nagomi Clinic ( Site 2305)
Toyonaka, Osaka 5600004, Japan
Tokyo Metropolitan Geriatric Hospital ( Site 2301)
Itabashi, Tokyo 173-0015, Japan
Ishikawa Clinic ( Site 2306)
Kyoto, 606-0851, Japan
Himuro Neurology Clinic ( Site 2304)
Osaka, 5340021, Japan
Inha University Hospital ( Site 2104)
Incheon, 22332, Korea, Republic of
Asan Medical Center-Department of Neurology ( Site 2101)
Seoul, 05505, Korea, Republic of
Samsung Medical Center ( Site 2102)
Seoul, 06351, Korea, Republic of
Ewha Womans University Seoul Hospital ( Site 2103)
Seoul, 07804, Korea, Republic of
CGM Research Trust ( Site 2001)
Christchurch, Canterbury 8011, New Zealand
Hospital Universitari Mutua Terrassa-Neurology ( Site 1607)
Terrassa, Barcelona 08222, Spain
HOSPITAL CLÍNIC DE BARCELONA ( Site 1609)
Barcelona, Cataluna 08036, Spain
Hospital de la Santa Creu i Sant Pau ( Site 1603)
Barcelona, Cataluna 08041, Spain
Clinica Universidad de Navarra-Neurology ( Site 1602)
Pamplona, Navarra 31008, Spain
Centro de Atención Especializada Oroitu ( Site 1610)
Getxo, Pais Vasco 48993, Spain
Hospital Universitario Doctor Peset-Neurología ( Site 1601)
Valencia, Valenciana, Comunitat 46017, Spain
Fundació ACE ( Site 1604)
Barcelona, 08034, Spain
Hospital Clinico San Carlos ( Site 1608)
Madrid, 28040, Spain
Hospital Viamed Montecanal-Neurociencia ( Site 1606)
Zaragoza, 50012, Spain
Brain Health Scotland Life Sciences ( Site 1810)
Edinburgh, Edinburgh, City Of EH12 9DQ, United Kingdom
Queen Elizabeth University Hospital-Glasgow Clinical Research Facility ( Site 1808)
Glasgow, Glasgow City G51 4TF, United Kingdom
Re:Cognition Health - London ( Site 1804)
London, London, City Of W1G 9JF, United Kingdom
Kingshill Research Centre ( Site 1807)
Swindon, Wiltshire SN3 6BW, United Kingdom
Re:Cognition Health - Birmingham ( Site 1801)
Birmingham, B16 8LT, United Kingdom
Re:Cognition Health - Plymouth ( Site 1803)
Plymouth, PL6 8BT, United Kingdom

References and documents

Study documents

Protocol and statistical analysis plan · Jul 7, 2022

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Dec 10, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05602727
Lead sponsor: Merck Sharp & Dohme LLC
Responsible party: Sponsor
First posted: Nov 2, 2022
Start date: Dec 2, 2022
Primary completion: Sep 27, 2023
Completion: Sep 27, 2023
Results posted: Oct 15, 2024
Last update: Dec 10, 2024

Study contacts

Medical Director

study director · Merck Sharp & Dohme LLC

Oversight

Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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