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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Alzheimer's Disease

In brief

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.

Key facts

Study ID

NCT05602727

Run by

Merck Sharp & Dohme LLC

People needed

99

Starts

2022-12-02

Expected to finish

2023-09-27

Last updated by the study team

2024-12-10

Who can join

Age: 55 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Neurology Center of North Orange County ( Site 0039) — Fullerton, California, United States
• California Neuroscience Research, LLC ( Site 0058) — Sherman Oaks, California, United States
• JEM Research Institute ( Site 0013) — Atlantis, Florida, United States
• Velocity Clinical Research, Hallandale Beach ( Site 0025) — Hallandale, Florida, United States
• K2 Medical Research ( Site 0057) — Maitland, Florida, United States
• Premier Clinical Research Institute ( Site 0038) — Miami, Florida, United States
• Collier Neurologic Specialists ( Site 0045) — Naples, Florida, United States
• Atlanta Center for Medical Research ( Site 0044) — Atlanta, Georgia, United States
• iResearch Atlanta ( Site 0016) — Decatur, Georgia, United States
• Alexian Brothers Medical Center ( Site 0011) — Elk Grove Village, Illinois, United States
• Tandem Clinical Research ( Site 0055) — Marrero, Louisiana, United States
• Global Medical Institutes LLC; Princeton Medical Institute ( Site 0053) — Princeton, New Jersey, United States
• Advanced Memory Research Institute of New Jersey ( Site 0027) — Toms River, New Jersey, United States
• Richmond Behavioral Associates ( Site 0008) — Staten Island, New York, United States
• AMC Research, LLC ( Site 0004) — Matthews, North Carolina, United States
• NeuroScience Research Center ( Site 0009) — Canton, Ohio, United States
• Summit Headlands ( Site 0018) — Portland, Oregon, United States
• Grayline Research Center ( Site 0003) — Wichita Falls, Texas, United States
• The Memory Clinic ( Site 0054) — Bennington, Vermont, United States
• Re:Cognition Health ( Site 0031) — Fairfax, Virginia, United States
• Northwest Clinical Research Center ( Site 0056) — Bellevue, Washington, United States
• Clinica Privada Banfield ( Site 0205) — Banfield, Buenos Aires, Argentina
• Hospital Italiano de Buenos Aires-Geriatrics ( Site 0210) — Buenos Aires, Buenos Aires F.D., Argentina
• Instituto Kremer ( Site 0202) — Córdoba, Córdoba Province, Argentina
• Banner Alzheimer's Institute ( Site 0017) — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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