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C: MK-3134+ Scopolamine

Phase 1

Dementia | Small molecule | Neurology |Merck & Company, Inc.|Last Updated: Nov 6, 2015

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment31

FDA Designations

No designations recorded

Clinical trial landscape

C: MK-3134+ Scopolamine · 1 trial · 1 indication

Phase 1 1
NCT01181310Placebo-Controlled Crossover Study to Evaluate Donepezil and MK-3134 for Reversal of Cognitive Impairment Associated With Scopolamine Administration (3134-005)(COMPLETED)Dementia
COMPLETED31 Analytics
PHASE1COMPLETED
Placebo-Controlled Crossover Study to Evaluate Donepezil and MK-3134 for Reversal of Cognitive Impairment Associated With Scopolamine Administration (3134-005)(COMPLETED)
DementiaUnlock trial analytics

Study Endpoints

Primary Endpoints

CogState Early Phase Battery, Groton Maze Learning Test (GMLT) as measured by the number of errors on the GMLT over time (area under the GMLT-time curve) over hours 1-12.
1, 2, 3, 4, 6, 8, and 12 hours relative to administration of SQ scopolamine or SQ placebo

Participants learned a hidden pathway through a maze (10 x 10 grid of tiles on a computer touch screen) using step-by-step guess, with trial and error feedback after each step. Once the pathway was learned, participants repeated the same pathway four more times. The number of pathway errors was used to indicate the level of cognitive function.

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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
A, B, D, E, CEXPERIMENTALParticipants received treatment A, B, D, E, C for Periods 1, 2, 3, 4, and 5, respectively.
B, C, E, A, DEXPERIMENTALParticipants received treatment B, C, E, A, D for Periods 1, 2, 3, 4, and 5, respectively.
C, D, A, B, EEXPERIMENTALParticipants received treatment C, D, A, B, E for Periods 1, 2, 3, 4, and 5, respectively.
D, E, B, C, AEXPERIMENTALParticipants received treatment D, E, B, C, A for Periods 1, 2, 3, 4, and 5, respectively.
E, A, C, D, BEXPERIMENTALParticipants received treatment E, A, C, D, B for Periods 1, 2, 3, 4, and 5, respectively.
A, C, B, E, DEXPERIMENTALParticipants received treatment A, C, B, E, D for Periods 1, 2, 3, 4, and 5, respectively.
B, D, C, A, EEXPERIMENTALParticipants received treatment B, D, C, A, E for Periods 1, 2, 3, 4, and 5, respectively.
C, E, D, B, AEXPERIMENTALParticipants received treatment C, E, D, B, A for Periods 1, 2, 3, 4, and 5, respectively.
D, A, E, C, BEXPERIMENTALParticipants received treatment D, A, E, C, B for Periods 1, 2, 3, 4, and 5, respectively.
E, B, A, D, CEXPERIMENTALParticipants received treatment E, B, A, D, C for Periods 1, 2, 3, 4, and 5, respectively.

Interventions

NameTypeDescription
A: Placebo to match Donepezil and MK-3134 + Placebo to match ScopolamineDRUGSingle doses of placebo to match both donepezil and MK-3134 PO, plus a single dose of placebo to match scopolamine SQ.
B: Placebo to match Donepezil and MK-3134 + Scopolamine 0.5 mgDRUGSingle doses of placebo to match both donepezil and MK-3134 PO, plus a single dose of scopolamine 0.5 mg SQ.
C: MK-3134 25 mg + Scopolamine 0.5 mgDRUGA single dose of MK-3134 PO 25 mg, plus a single dose of scopolamine SQ 0.5 mg.
D: Donepezil 10 mg + Scopolamine 0.5 mgDRUGA single dose of donepezil 10 mg PO, plus a single dose of scopolamine 0.5 mg SQ.
E: Combo: Donepezil 10 mg + MK-3134 25 mg + Scopolamine 0.5 mgDRUGA combination of single doses of all active drugs: donepezil 10 mg and MK-3134 25 mg PO, plus scopolamine, SQ.
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Eligibility Criteria

Age Range18 Years to 40 Years
SexMALE
Healthy VolunteersYes

Participants were eligible for inclusion in the study who were: * Male between 18 and 40 years of age. * Non-smokers, in good health (as defined in protocol), and were willing to follow study-related procedures. Participants were not eligible for inclusion in the study if they: * Had a history of...

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Frequently asked questions about C: MK-3134+ Scopolamine

What is MK-3134 plus Scopolamine used for?

MK-3134 plus Scopolamine is an investigational small molecule combination being studied for dementia. It was evaluated in a Phase 1 clinical trial for the reversal of cognitive impairment associated with scopolamine administration. The drug is still in clinical development and is not approved.

Who makes MK-3134 plus Scopolamine?

MK-3134 plus Scopolamine is being developed by Merck & Company, Inc., which trades under the ticker MRK. The company conducted a Phase 1 clinical trial of the combination for dementia.

What phase is MK-3134 plus Scopolamine in?

MK-3134 plus Scopolamine is in Phase 1 clinical development. It has completed one Phase 1 trial, which was a placebo-controlled crossover study. The drug is investigational and has not been approved.

What clinical trials is MK-3134 plus Scopolamine in?

MK-3134 plus Scopolamine has one completed clinical trial, NCT01181310, titled "Placebo-Controlled Crossover Study to Evaluate Donepezil and MK-3134 for Reversal of Cognitive Impairment Associated With Scopolamine Administration (3134-005)." The trial enrolled 31 healthy male volunteers.

Is MK-3134 plus Scopolamine the same as donepezil?

No, MK-3134 plus Scopolamine is not the same as donepezil. The clinical trial NCT01181310 evaluated both donepezil and MK-3134 for reversal of cognitive impairment associated with scopolamine administration, but they are separate investigational agents.