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Efficacy and Safety of MK-1167 in Participants With Alzheimer's Disease Dementia Taking Stable Donepezil Treatment (MK-1167-007)
A Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Assess the Safety, Tolerability, and Pharmacokinetics of MK-1167 Administered to Patients With Alzheimer's Disease Receiving Stable Donepezil Treatment
Lead sponsor
Assets
Donepezil / MK-1167
Listed sites
3
Recruiting sites
-
Enrollment
28
actual
Study population
Alzheimer’s disease
Key I/E criteria
•Alzheimer's disease•Study partner/caregiver required
Primary endpoints
•Adverse Event (AE)•Number of Participants Who Discontinued Study Treatment Due to an AE
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Drug assets
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
Exclusion criteria
Endpoints (52)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Safety / tolerability / PK
28 endpointsNumber of Participants Who Experienced an Adverse Event (AE)
Time frame:Up to approximately 7 weeks
event count, event
Number of Participants Who Experienced an Adverse Event (AE)
Time frame:Up to approximately 7 weeks
event count, event
Posted result
| Group | Value (count_of_participants), Participants | Reported bounds |
|---|---|---|
| Panel A: MK-1167 6mg QD + Donepezil 10mg QDn=12 Participants | 3 | - |
| Panel A: MK-1167 3mg QD + Donepezil 10mg QDn=12 Participants | 5 | - |
| Panel A: Placebo to MK-1167 + Donepezil 10mg QDn=4 Participants | 2 | - |
| Panel B: MK-1167 6mg QD+ Donepezil 10mg QDn=9 Participants | 6 | - |
| Panel B: Placebo to MK-1167 + Donepezil 10mg QDn=3 Participants | 0 | - |
Panel A: Area Under the Plasma Concentration-Time Curve From 0 to 24 Hours (AUC0-24) After Administration of 6mg of MK-1167
Time frame:Day 1: Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours postdose
concentration, descriptive
Panel A: AUC0-24 After Administration of 3mg of MK-1167
Time frame:Days 8, 21: Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours postdose
concentration, descriptive
Panel A: Maximum Plasma Concentration (Cmax) After Administration of 6mg of MK-1167
Time frame:Day 1: Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours postdose
concentration, descriptive
Panel A: Cmax After Administration of 3mg of MK-1167
Time frame:Days 8, 21: Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours postdose
concentration, descriptive
Panel B: Cmax After Administration of 6mg of MK-1167
Time frame:Days 1, 23, 31: Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours postdose
concentration, descriptive
Panel A: Plasma Concentration at 24 Hours (C24) After Administration of 6mg of MK-1167
Time frame:Day 1: Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours postdose
concentration, descriptive
Panel A: Time to Maximum Plasma Concentration (Tmax) After Administration of 6mg of MK-1167
Time frame:Day 1: Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours postdose
time to event, event
Panel A: Tmax After Administration of 3mg of MK-1167
Time frame:Days 8, 21: Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours postdose
time to event, event
Panel B: Tmax After Administration of 6mg of MK-1167
Time frame:Days 1, 23, 31: Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours postdose
time to event, event
Panel A: Area Under the Plasma Concentration-Time Curve From 0 to 24 Hours (AUC0-24) After Administration of 6mg of MK-1167
Time frame:Day 1: Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours postdose
concentration, descriptive
Posted result
| Group | Value (geometric_mean), μM*hour | Reported bounds |
|---|---|---|
| Panel A: MK-1167 6mg QD + Donepezil 10mg QDn=10 Participants | 2.17 | -1.22 - 3.84 |
Panel A: Apparent Terminal Half-Life (t1/2) After Administration of 3mg of MK-1167
Time frame:Day 21: Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 120, 240, 360 and 480 hours postdose
concentration, descriptive
Panel A: AUC0-24 After Administration of 3mg of MK-1167
Time frame:Days 8, 21: Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours postdose
concentration, descriptive
Posted result
| Group | Value (geometric_mean), μM*hour | Reported bounds |
|---|---|---|
| Panel A: MK-1167 3mg QD + Donepezil 10mg QDDay 8n=12 Participants | 8.70 | -4.95 - 15.3 |
| Day 21n=10 Participants | 8.08 | -4.56 - 14.3 |
Panel B: t1/2 After Administration of 6mg of MK-1167
Time frame:Day 31: Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 120, 240, 360 and 480 hours postdose
concentration, descriptive
Panel A: Maximum Plasma Concentration (Cmax) After Administration of 6mg of MK-1167
Time frame:Day 1: Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours postdose
concentration, descriptive
Posted result
| Group | Value (geometric_mean), μmol/Liter | Reported bounds |
|---|---|---|
| Panel A: MK-1167 6mg QD + Donepezil 10mg QDn=10 Participants | 0.129 | -0.0731 - 0.228 |
Panel A: Cmax After Administration of 3mg of MK-1167
Time frame:Days 8, 21: Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours postdose
concentration, descriptive
Posted result
| Group | Value (geometric_mean), μmol/Liter | Reported bounds |
|---|---|---|
| Panel A: MK-1167 3mg QD + Donepezil 10mg QDDay 8n=12 Participants | 0.434 | -0.247 - 0.761 |
| Day 21n=10 Participants | 0.413 | -0.234 - 0.729 |
Panel B: Cmax After Administration of 6mg of MK-1167
Time frame:Days 1, 23, 31: Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours postdose
concentration, descriptive
Posted result
| Group | Value (geometric_mean), μmol/Liter | Reported bounds |
|---|---|---|
| Panel B: MK-1167 6mg QD + Donepezil 10mg QDDay 1n=9 Participants | 0.145 | -0.121 - 0.174 |
| Day 23n=8 Participants | 1.11 | -0.919 - 1.35 |
| Day 31n=8 Participants | 1.14 | -0.941 - 1.38 |
Panel A: Plasma Concentration at 24 Hours (C24) After Administration of 6mg of MK-1167
Time frame:Day 1: Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours postdose
concentration, descriptive
Posted result
| Group | Value (geometric_mean), μmol/Liter | Reported bounds |
|---|---|---|
| Panel A: MK-1167 6mg QD + Donepezil 10mg QDn=10 Participants | 0.0902 | -0.0500 - 0.163 |
Panel B: Day 23 to Day 1 Accumulation Ratio of Cmax After Administration of 6mg of MK-1167
Time frame:Days 1, 23: Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours postdose
concentration, descriptive
Panel B: Day 31 to Day 1 Accumulation Ratio of Cmax After Administration of 6mg of MK-1167
Time frame:Days 1, 31: Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours postdose
concentration, descriptive
Panel A: Time to Maximum Plasma Concentration (Tmax) After Administration of 6mg of MK-1167
Time frame:Day 1: Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours postdose
time to event, event
Posted result
| Group | Value (median), hours | Reported bounds |
|---|---|---|
| Panel A: MK-1167 6mg QD + Donepezil 10mg QDn=10 Participants | 1.54 | -0.50 - 8.00 |
Panel A: Tmax After Administration of 3mg of MK-1167
Time frame:Days 8, 21: Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours postdose
time to event, event
Posted result
| Group | Value (median), hours | Reported bounds |
|---|---|---|
| Panel A: MK-1167 3mg QD + Donepezil 10mg QDDay 8n=12 Participants | 6.00 | -0.00 - 23.97 |
| Day 21n=10 Participants | 4.01 | -1.22 - 11.92 |
Panel B: Tmax After Administration of 6mg of MK-1167
Time frame:Days 1, 23, 31: Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours postdose
time to event, event
Posted result
| Group | Value (median), hours | Reported bounds |
|---|---|---|
| Panel B: MK-1167 6mg QD + Donepezil 10mg QDDay 1n=9 Participants | 1.08 | -0.48 - 5.78 |
| Day 23n=8 Participants | 4.03 | -0.58 - 11.92 |
| Day 31n=8 Participants | 2.97 | -0.42 - 11.90 |
Panel A: Apparent Terminal Half-Life (t1/2) After Administration of 3mg of MK-1167
Time frame:Day 21: Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 120, 240, 360 and 480 hours postdose
concentration, descriptive
Posted result
| Group | Value (geometric_mean), hours | Geometric coefficient of variation |
|---|---|---|
| Panel A: MK-1167 3 mg QD + Donepezil 10mg QDn=10 Participants | 194 | 48.2 |
Panel B: t1/2 After Administration of 6mg of MK-1167
Time frame:Day 31: Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 120, 240, 360 and 480 hours postdose
concentration, descriptive
Posted result
| Group | Value (geometric_mean), hour | Geometric coefficient of variation |
|---|---|---|
| Panel B: MK-1167 6mg QD + Donepezil 10mg QDn=8 Participants | 193 | 40.4 |
Panel B: Day 23 to Day 1 Accumulation Ratio of Cmax After Administration of 6mg of MK-1167
Time frame:Days 1, 23: Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours postdose
concentration, descriptive
Posted result
| Group | Value (geometric_mean), Ratio | Reported bounds |
|---|---|---|
| Panel B: MK-1167 6mg QD + Donepezil 10mg QDn=8 Participants | 7.69 | -6.46 - 9.16 |
Panel B: Day 31 to Day 1 Accumulation Ratio of Cmax After Administration of 6mg of MK-1167
Time frame:Days 1, 31: Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours postdose
concentration, descriptive
Posted result
| Group | Value (geometric_mean), Ratio | Reported bounds |
|---|---|---|
| Panel B: MK-1167 6mg QD + Donepezil 10mg QDn=8 Participants | 7.88 | -6.62 - 9.38 |
Other (unclassified)
24 endpointsNumber of Participants Who Discontinued Study Treatment Due to an AE
Time frame:Up to approximately 4 weeks
event count, event
Number of Participants Who Discontinued Study Treatment Due to an AE
Time frame:Up to approximately 4 weeks
event count, event
Posted result
| Group | Value (count_of_participants), Participants | Reported bounds |
|---|---|---|
| Panel A: MK-1167 6mg QD + Donepezil 10mg QDn=12 Participants | 0 | - |
| Panel A: MK-1167 3mg QD + Donepezil 10mg QDn=12 Participants | 0 | - |
| Panel A: Placebo to MK-1167 + Donepezil 10mg QDn=4 Participants | 0 | - |
| Panel B: MK-1167 6mg QD + Donepezil 10mg QDn=9 Participants | 1 | - |
| Panel B: Placebo to MK-1167 + Donepezil 10mg QDn=3 Participants | 0 | - |
Panel B: AUC0-24 After Administration of 6mg of MK-1167
Time frame:Days 1, 23, 31: Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours postdose
concentration, descriptive
Panel A: C24 After Administration of 3mg of MK-1167
Time frame:Days 8, 21: Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours postdose
concentration, descriptive
Panel B: C24 After Administration of 6mg of MK-1167
Time frame:Days 1, 23, 31: Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours postdose
concentration, descriptive
Panel A: Apparent Clearance (CL/F) After Administration of 3mg of MK-1167
Time frame:Day 21: Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 120, 240, 360 and 480 hours postdose
ratio, descriptive
Panel B: CL/F After Administration of 6mg of MK-1167
Time frame:Day 31: Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 120, 240, 360 and 480 hours postdose
ratio, descriptive
Panel B: AUC0-24 After Administration of 6mg of MK-1167
Time frame:Days 1, 23, 31: Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours postdose
concentration, descriptive
Posted result
| Group | Value (geometric_mean), μM*hour | Reported bounds |
|---|---|---|
| Panel B: MK-1167 6mg QD + Donepezil 10mg QDDay 1n=9 Participants | 2.48 | -2.04 - 3.01 |
| Day 23n=8 Participants | 22.2 | -18.1 - 27.1 |
| Day 31n=8 Participants | 22.9 | -18.8 - 28.0 |
Panel A: Apparent Volume of Distribution (Vz/F) After Administration of 3mg of MK-1167
Time frame:Day 21: Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 120, 240, 360 and 480 hours postdose
ratio, descriptive
Panel B: Vz/F After Administration of 6mg of MK-1167
Time frame:Day 31: Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 120, 240, 360 and 480 hours postdose
ratio, descriptive
Panel B: Day 23 to Day 1 Accumulation Ratio of AUC0-24 After Administration of 6mg of MK-1167
Time frame:Days 1, 23: Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours postdose
concentration, descriptive
Panel B: Day 31 to Day 1 Accumulation Ratio of AUC0-24 After Administration of 6mg of MK-1167
Time frame:Days 1, 31: Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours postdose
concentration, descriptive
Panel A: C24 After Administration of 3mg of MK-1167
Time frame:Days 8, 21: Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours postdose
concentration, descriptive
Posted result
| Group | Value (geometric_mean), μmol/Liter | Reported bounds |
|---|---|---|
| Panel A: MK-1167 3mg QD + Donepezil 10mg QDDay 8n=12 Participants | 0.362 | -0.203 - 0.647 |
| Day 21n=10 Participants | 0.313 | -0.174 - 0.565 |
Panel B: C24 After Administration of 6mg of MK-1167
Time frame:Days 1, 23, 31: Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours postdose
concentration, descriptive
Posted result
| Group | Value (geometric_mean), μmol/Liter | Reported bounds |
|---|---|---|
| Panel B: MK-1167 6mg QD + Donepezil 10mg QDDay 1n=9 Participants | 0.0917 | -0.0731 - 0.115 |
| Day 23n=8 Participants | 0.729 | -0.576 - 0.922 |
| Day 31n=8 Participants | 0.875 | -0.691 - 1.11 |
Panel B: Day 23 to Day 1 Accumulation Ratio of C24 After Administration of 6mg of MK-1167
Time frame:Days 1, 23: Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours postdose
concentration, descriptive
Panel B: Day 31 to Day 1 Accumulation Ratio of C24 After Administration of 6mg of MK-1167
Time frame:Days 1, 31: Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours postdose
concentration, descriptive
Panel A: Apparent Clearance (CL/F) After Administration of 3mg of MK-1167
Time frame:Day 21: Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 120, 240, 360 and 480 hours postdose
ratio, descriptive
Posted result
| Group | Value (geometric_mean), Liter/hour | Geometric coefficient of variation |
|---|---|---|
| Panel A: MK-1167 3mg QD + Donepezil 10mg QDn=10 Participants | 0.879 | 166.9 |
Panel B: CL/F After Administration of 6mg of MK-1167
Time frame:Day 31: Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 120, 240, 360 and 480 hours postdose
ratio, descriptive
Posted result
| Group | Value (geometric_mean), Liter/hour | Geometric coefficient of variation |
|---|---|---|
| Panel B: MK-1167 6mg QD + Donepezil 10mg QDn=8 Participants | 0.606 | 32.3 |
Panel A: Apparent Volume of Distribution (Vz/F) After Administration of 3mg of MK-1167
Time frame:Day 21: Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 120, 240, 360 and 480 hours postdose
ratio, descriptive
Posted result
| Group | Value (geometric_mean), Liter | Geometric coefficient of variation |
|---|---|---|
| Panel A: MK-1167 3mg QD + Donepezil 10mg QDn=10 Participants | 246 | 166.6 |
Panel B: Vz/F After Administration of 6mg of MK-1167
Time frame:Day 31: Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 120, 240, 360 and 480 hours postdose
ratio, descriptive
Posted result
| Group | Value (geometric_mean), Liter | Geometric coefficient of variation |
|---|---|---|
| Panel B: MK-1167 6mg QD + Donepezil 10mg QDn=8 Participants | 169 | 19.7 |
Panel B: Day 23 to Day 1 Accumulation Ratio of AUC0-24 After Administration of 6mg of MK-1167
Time frame:Days 1, 23: Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours postdose
concentration, descriptive
Posted result
| Group | Value (geometric_mean), Ratio | Reported bounds |
|---|---|---|
| Panel B: MK-1167 6mg QD + Donepezil 10mg QDn=8 Participants | 8.95 | -7.80 - 10.27 |
Panel B: Day 31 to Day 1 Accumulation Ratio of AUC0-24 After Administration of 6mg of MK-1167
Time frame:Days 1, 31: Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours postdose
concentration, descriptive
Posted result
| Group | Value (geometric_mean), Ratio | Reported bounds |
|---|---|---|
| Panel B: MK-1167 6mg QD + Donepezil 10mg QDn=8 Participants | 9.26 | -8.08 - 10.62 |
Panel B: Day 23 to Day 1 Accumulation Ratio of C24 After Administration of 6mg of MK-1167
Time frame:Days 1, 23: Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours postdose
concentration, descriptive
Posted result
| Group | Value (geometric_mean), Ratio | Reported bounds |
|---|---|---|
| Panel B: MK-1167 6mg QD + Donepezil 10mg QDn=8 Participants | 7.94 | -6.64 - 9.50 |
Panel B: Day 31 to Day 1 Accumulation Ratio of C24 After Administration of 6mg of MK-1167
Time frame:Days 1, 31: Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours postdose
concentration, descriptive
Posted result
| Group | Value (geometric_mean), Ratio | Reported bounds |
|---|---|---|
| Panel B: MK-1167 6mg QD + Donepezil 10mg QDn=8 Participants | 9.54 | -7.97 - 11.40 |
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.