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MK-1942/Donepezil Interactions in Participants With Alzheimer's Disease (MK-1942-005)
Phase 1 trial testing MK-1942 in Alzheimer's Disease in 27 participants. Completed in 18 May 2022.
| Lead sponsor | Merck Sharp & Dohme LLC |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 27 |
| Start date | 16 February 2021 |
| Primary completion | 18 May 2022 |
| Estimated completion | 18 May 2022 |
| Sites | 4 locations across United States |
Merck Sharp & Dohme LLC — full company profile →
Adults 50 to 85, any sex, with Alzheimer's Disease. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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.
| Group | Value | 95% CI |
|---|---|---|
| MK-1942 8 mg + Donepezil AD | 13 | |
| MK-1942 15 mg + Donepezil AD | 4 | |
| MK-1942 30 mg + Donepezil AD | 4 | |
| MK-1942 50 mg + Donepezil AD | 5 | |
| Placebo + Donepezil AD | 4 |
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.
| Group | Value | 95% CI |
|---|---|---|
| MK-1942 8 mg AD | 0 | |
| MK-1942 15 mg AD | 0 | |
| MK-1942 30 mg AD | 0 | |
| MK-1942 50 mg AD | 0 | |
| Placebo AD | 0 |
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.
| Group | Value | 95% CI |
|---|---|---|
| MK-1942 8 mg | 1 | |
| MK-1942 15 mg | 0 | |
| MK-1942 30 mg | 0 | |
| MK-1942 50 mg | 0 | |
| Placebo AD | 1 |
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.
| Group | Value | 95% CI |
|---|---|---|
| MK-1942 8 mg | 0 | |
| MK-1942 15 mg | 0 | |
| MK-1942 30 mg | 0 | |
| MK-1942 50 mg | 0 | |
| Placebo AD | 0 |
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
| Group | Value | 95% CI |
|---|---|---|
| MK-1942 8 mg | 0 | |
| MK-1942 15 mg | 0 | |
| MK-1942 30 mg | 0 | |
| MK-1942 50 mg | 0 | |
| Placebo AD | 0 |
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.
| Group | Value | 95% CI |
|---|---|---|
| MK-1942 8 mg | -2.27 | ± 1.25 |
| MK-1942 15 mg | 2.56 | ± 1.65 |
| MK-1942 30 mg | 6.14 | ± 2.27 |
| MK-1942 50 mg | 0.21 | ± 2.81 |
| Placebo AD | -4.53 | ± 1.06 |
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.
| Group | Value | 95% CI |
|---|---|---|
| MK-1942 8 mg | 2.48 | ± 2.08 |
| MK-1942 15 mg | -0.15 | ± 2.59 |
| MK-1942 30 mg | 0.88 | ± 2.09 |
| MK-1942 50 mg | 1.45 | ± 2.19 |
| Placebo AD | 5.93 | ± 4.00 |
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.
| Group | Value | 95% CI |
|---|---|---|
| MK-1942 8 mg | -0.95 | ± 0.93 |
| MK-1942 15 mg | 0.56 | ± 2.01 |
| MK-1942 30 mg | 1.17 | ± 1.51 |
| MK-1942 50 mg | 0.10 | ± 1.39 |
| Placebo AD | -1.73 | ± 3.36 |
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.
| Group | Value | 95% CI |
|---|---|---|
| MK-1942 8 mg | 1 | |
| MK-1942 15 mg | 0 | |
| MK-1942 30 mg | 0 | |
| MK-1942 50 mg | 1 | |
| Placebo AD | 0 |
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.
| Group | Value | 95% CI |
|---|---|---|
| MK-1942 8 mg | 0 | |
| MK-1942 15 mg | 1 | |
| MK-1942 30 mg | 0 | |
| MK-1942 50 mg | 0 | |
| Placebo AD | 0 |
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.
| Group | Value | 95% CI |
|---|---|---|
| MK-1942 8 mg | 10 | |
| MK-1942 15 mg | 0 | |
| MK-1942 30 mg | 0 | |
| MK-1942 50 mg | 0 | |
| Placebo AD | 0 |
AUC0-12 is reported for the first day of treatment of each MK-1942 dose.
| Group | Value | 95% CI |
|---|---|---|
| MK-1942 8 mg + Donepezil AD | 1760 | 1390 – 2240 |
| MK-1942 15 mg + Donepezil AD | 3580 | 2860 – 4490 |
| MK-1942 30 mg + Donepezil AD | 6650 | 5330 – 8280 |
| MK-1942 50 mg + Donepezil AD | 11600 | 9110 – 14700 |
Time frame: Up to 42 days. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | MK-1942 8 mg BID 7 Days | MK-1942 15 mg BID 7 Days | MK-1942 30 mg Bid 7D | MK-1942 50 mg BID & Days | MK-1942 Total | Placebo Bid |
|---|---|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | — | — | — | — | — | — |
| Dizziness | Nervous system disorders | — | — | — | — | — | — |
| Nystagmus | Nervous system disorders | — | — | — | — | — | — |
| Diarrhoea | Gastrointestinal disorders | — | — | — | — | — | — |
| Vomiting | Gastrointestinal disorders | — | — | — | — | — | — |
| Headache | Nervous system disorders | — | — | — | — | — | — |
| Scleral hyperaemia | Eye disorders | — | — | — | — | — | — |
| Scleritis | Eye disorders | — | — | — | — | — | — |
| Vision blurred | Eye disorders | — | — | — | — | — | — |
| Anal incontinence | Gastrointestinal disorders | — | — | — | — | — | — |
| Constipation | Gastrointestinal disorders | — | — | — | — | — | — |
| Dyspepsia | Gastrointestinal disorders | — | — | — | — | — | — |
| Gait disturbance | General disorders | — | — | — | — | — | — |
| Medical device site injury | General disorders | — | — | — | — | — | — |
| Oedema peripheral | General disorders | — | — | — | — | — | — |
| Vessel puncture site bruise | General disorders | — | — | — | — | — | — |
| Upper respiratory tract infection | Infections and infestations | — | — | — | — | — | — |
| Skin laceration | Injury, poisoning and procedural complications | — | — | — | — | — | — |
| Alanine aminotransferase increased | Investigations | — | — | — | — | — | — |
| Aspartate aminotransferase increased | Investigations | — | — | — | — | — | — |
| Blood sodium decreased | Investigations | — | — | — | — | — | — |
| Electrocardiogram QT prolonged | Investigations | — | — | — | — | — | — |
| Electrocardiogram T wave biphasic | Investigations | — | — | — | — | — | — |
| Haemoglobin decreased | Investigations | — | — | — | — | — | — |
| Decreased appetite | Metabolism and nutrition disorders | — | — | — | — | — | — |
| Back pain | Musculoskeletal and connective tissue disorders | — | — | — | — | — | — |
| Myalgia | Musculoskeletal and connective tissue disorders | — | — | — | — | — | — |
| Pain in extremity | Musculoskeletal and connective tissue disorders | — | — | — | — | — | — |
| Balance disorder | Nervous system disorders | — | — | — | — | — | — |
| Dizziness postural | Nervous system disorders | — | — | — | — | — | — |
| Dystonia | Nervous system disorders | — | — | — | — | — | — |
| Anxiety | Psychiatric disorders | — | — | — | — | — | — |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | — | — | — | — | — | — |
| Dermatitis contact | Skin and subcutaneous tissue disorders | — | — | — | — | — | — |
| Pruritus | Skin and subcutaneous tissue disorders | — | — | — | — | — | — |
| Hypertension | Vascular disorders | — | — | — | — | — | — |
Data from ClinicalTrials.gov NCT04308304 adverse events section.
The study investigated the effects on safety and pharmacokinetics (PK) of MK-1942 and donepezil when co-administered to participants with Alzheimer's Disease with mild-to-moderate cognitive impairment stably treated with donepezil. The objectives of this study were to determine if the combination of MK-1942 with donepezil increases the incidence or severity of adverse events (AEs) previously reported for these agents alone, or results in unanticipated AEs in the patient population targeted for MK-1942 treatment. In addition, changes in the PK parameters of either MK-1942 or donepezil as a result of co-administration were assessed.
5 peer-reviewed publications reference this trial (live from Europe PMC):
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