Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MK-1942 · 1 trial · 1 indication
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 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.
The number of participants with clinically significant 12-lead ECGs is presented. Recordings were made throughout the study, with the participant in a semi-recumbent position having rested in this position for at least 10 minutes beforehand.
The number of participants with abnormal (impaired) results on targeted neurological exams will be presented. The targeted neurological exam contains Modules 1, 2 and 5 of the general examination, focusing on arousal, cranial nerve function, and gait and will be administered several times throughout the treatment period starting on Day 1 up until Day 29. The number of participants with abnormal (impaired) results on targeted neurological exams will be reported. Each exam will be graded as Normal or Impaired with the abnormality described.
The number of participants with suicidality using the C-SSRS is presented. The C-SSR will be used in this study only for the purpose of safety monitoring by measuring the incidence of different types of suicidality categories during treatment. C-SSRS assessment will be based upon a clinician's interpretation of the participant's responses to the C-SSRS questions, not by a numbered scale. Suicidal ideation and/or behaviors identified on the C-SSRS may not be considered an adverse event, based on the investigator's judgment. Participants who report at least one occurrence of suicidal behavior or suicidal ideation will be counted as having experienced suicidality. Suicidal behavior includes suicide attempt, aborted attempt, interrupted attempt, or preparatory behavior. Suicidal ideation include a wish to die or active suicidal thought with or without method, intent or plan.
The mean change from baseline in HR is presented. Change in HR was determined the first day of treatment with a new dose of MK-1942. A negative value indicates a decrease in HR relative to baseline, and a positive value indicates an increase.
The mean change from baseline in SBP is presented. Change in SBP was determined the first day of treatment with a new dose of MK-1942. Negative values represent a decrease in SBP relative to baseline, and positive values represent an increase.
The mean change from baseline in DBP is presented. Change in DBP was determined the first day of treatment with a new dose of MK-1942. Negative values represent a decrease in DBP relative to baseline, and positive values represent an increase.
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. The number of participants with abnormal chemistry-related AEs is reported.
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. The number of participants with abnormal hematology-related AEs is reported.
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. The number of participants with an abnormal urinalysis results AE is reported.
| Arm | Type | Description |
|---|---|---|
| Donepezil | EXPERIMENTAL | Participants receive Dose Level 1: 8-mg MK-1942 twice daily (BID) x 7 days (7D), Day 1 to Day 7; Dose Level 2: 15-mg MK-1942 BID x 7D, Day 8 to Day 14; Dose Level 3: 30-mg MK-1942 BID x 7D, Day 15 to Day 21; Dose Level 4: ≤50-mg MK-1942 BID x 7D (Provisional Dose Level), Day 22 to Day 28 All participants to receive Donepezil once daily. |
| Placebo | PLACEBO_COMPARATOR | Placebo to MK-1942 BID x 21 \[28\] D All participants to receive Donepezil once daily. |
| Name | Type | Description |
|---|---|---|
| MK-1942 | DRUG | MK-1942 1 mg, 5 mg, and/or 10 mg capsules taken twice daily (BID) by mouth. |
| Donepezil | DRUG | Donepezil 5 mg and/or 10 mg tablets taken once daily (QD) by mouth. |
| Placebo | DRUG | Placebo capsule matched to MK-1942 taken BID by mouth. |
Inclusion Criteria: * Body mass index (BMI) ≥18 and ≤35 kg/m\^2, inclusive. * Is in good health based on medical history, physical examination, vital sign measures and electrocardiogram performed prior to randomization. * Have a negative urine drug screen prior to randomization. * Have a history of...
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MK-1942 is an investigational small molecule being studied for the treatment of Alzheimer's Disease. It is currently in Phase 1 clinical development. The drug is being evaluated in patients with Alzheimer's Disease, and it is not yet approved by regulatory authorities.
MK-1942 is being developed by Merck & Company, Inc., which trades under the ticker symbol MRK. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug for Alzheimer's Disease.
MK-1942 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory agency. The drug is being studied for its potential use in treating Alzheimer's Disease.
MK-1942 has one completed Phase 1 clinical trial, NCT04308304, which studied MK-1942 and donepezil interactions in participants with Alzheimer's Disease. The trial enrolled 27 participants in the United States and was placebo-controlled, randomized, and double-blind.
No, MK-1942 is not the same as donepezil. MK-1942 is an investigational drug being developed by Merck. A clinical trial, NCT04308304, was conducted to study how MK-1942 interacts with donepezil in participants with Alzheimer's Disease, indicating they are separate compounds.