Placebo-Controlled Crossover Study to Evaluate Donepezil and MK-3134 for Reversal of Cognitive Impairment Associated With Scopolamine Administration (3134-005)(COMPLETED)

November 5, 2015 updated by: Merck Sharp & Dohme LLC

A Five-Period, Placebo-Controlled, Crossover Study to Evaluate the Effect of Donepezil and MK-3134 on Reversal of Cognitive Impairment Associated With a Single-Dose of Scopolamine.

The drug, scopolamine, can result in short-term impairments of cognitive function, attention, and memory that resemble those seen in aging and Alzheimer's disease. This study tested the capability of both individual and combined doses of MK-3134 and the current standard treatment: donepezil (Aricept), to reverse such impairments, following a single dose of scopolamine. Participants were evaluated after each of 5 different treatment periods (in a cross-over, double-dummy design): A: placebo to match both donepezil (oral [PO]) and MK-3134 (PO) followed by placebo scopolamine (subcutaneous [SQ]); B: placebo to match both donepezil (PO) and MK-3134 (PO), followed by scopolamine SQ; C: MK-3134 (PO) followed by scopolamine SQ; D: donepezil (PO) followed by scopolamine SQ; E: MK-3134 (PO) and donepezil (PO) followed by scopolamine SQ. The doses of MK3134, donepezil, and scopolamine were the same over all treatment arms in which the specified drug was administered. There were 8 total visits for each treatment period, including 5 Treatment Visits requiring 14-day intervals between visits for study-drug washout. Participants were assessed for cognitive function before and after each treatment period during the Treatment Visits.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
31

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 illness that, in the opinion of the study investigator or as specified in protocol, might confound the results of the study or posed an potential, additional risk to the participant if they were to participate in the study.
  • Were taking any medication (prescription, nonprescription, vitamin supplements or herbal, illicit or legitimate) except for acetaminophen.
  • Had a history of any significant head injury/trauma.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: A, B, D, E, C
Participants received treatment A, B, D, E, C for Periods 1, 2, 3, 4, and 5, respectively.
Drug: A: Placebo to match Donepezil and MK-3134 + Placebo to match Scopolamine
Single doses of placebo to match both donepezil and MK-3134 PO, plus a single dose of placebo to match scopolamine SQ.
Drug: B: Placebo to match Donepezil and MK-3134 + Scopolamine 0.5 mg
Single doses of placebo to match both donepezil and MK-3134 PO, plus a single dose of scopolamine 0.5 mg SQ.
Drug: C: MK-3134 25 mg + Scopolamine 0.5 mg
A single dose of MK-3134 PO 25 mg, plus a single dose of scopolamine SQ 0.5 mg.
Drug: D: Donepezil 10 mg + Scopolamine 0.5 mg
A single dose of donepezil 10 mg PO, plus a single dose of scopolamine 0.5 mg SQ.
Other Names:
  • Aricept (donepezil)
Drug: E: Combo: Donepezil 10 mg + MK-3134 25 mg + Scopolamine 0.5 mg
A combination of single doses of all active drugs: donepezil 10 mg and MK-3134 25 mg PO, plus scopolamine, SQ.
Other Names:
  • Aricept (donepezil)
Experimental: B, C, E, A, D
Participants received treatment B, C, E, A, D for Periods 1, 2, 3, 4, and 5, respectively.
Drug: A: Placebo to match Donepezil and MK-3134 + Placebo to match Scopolamine
Single doses of placebo to match both donepezil and MK-3134 PO, plus a single dose of placebo to match scopolamine SQ.
Drug: B: Placebo to match Donepezil and MK-3134 + Scopolamine 0.5 mg
Single doses of placebo to match both donepezil and MK-3134 PO, plus a single dose of scopolamine 0.5 mg SQ.
Drug: C: MK-3134 25 mg + Scopolamine 0.5 mg
A single dose of MK-3134 PO 25 mg, plus a single dose of scopolamine SQ 0.5 mg.
Drug: D: Donepezil 10 mg + Scopolamine 0.5 mg
A single dose of donepezil 10 mg PO, plus a single dose of scopolamine 0.5 mg SQ.
Other Names:
  • Aricept (donepezil)
Drug: E: Combo: Donepezil 10 mg + MK-3134 25 mg + Scopolamine 0.5 mg
A combination of single doses of all active drugs: donepezil 10 mg and MK-3134 25 mg PO, plus scopolamine, SQ.
Other Names:
  • Aricept (donepezil)
Experimental: C, D, A, B, E
Participants received treatment C, D, A, B, E for Periods 1, 2, 3, 4, and 5, respectively.
Drug: A: Placebo to match Donepezil and MK-3134 + Placebo to match Scopolamine
Single doses of placebo to match both donepezil and MK-3134 PO, plus a single dose of placebo to match scopolamine SQ.
Drug: B: Placebo to match Donepezil and MK-3134 + Scopolamine 0.5 mg
Single doses of placebo to match both donepezil and MK-3134 PO, plus a single dose of scopolamine 0.5 mg SQ.
Drug: C: MK-3134 25 mg + Scopolamine 0.5 mg
A single dose of MK-3134 PO 25 mg, plus a single dose of scopolamine SQ 0.5 mg.
Drug: D: Donepezil 10 mg + Scopolamine 0.5 mg
A single dose of donepezil 10 mg PO, plus a single dose of scopolamine 0.5 mg SQ.
Other Names:
  • Aricept (donepezil)
Drug: E: Combo: Donepezil 10 mg + MK-3134 25 mg + Scopolamine 0.5 mg
A combination of single doses of all active drugs: donepezil 10 mg and MK-3134 25 mg PO, plus scopolamine, SQ.
Other Names:
  • Aricept (donepezil)
Experimental: D, E, B, C, A
Participants received treatment D, E, B, C, A for Periods 1, 2, 3, 4, and 5, respectively.
Drug: A: Placebo to match Donepezil and MK-3134 + Placebo to match Scopolamine
Single doses of placebo to match both donepezil and MK-3134 PO, plus a single dose of placebo to match scopolamine SQ.
Drug: B: Placebo to match Donepezil and MK-3134 + Scopolamine 0.5 mg
Single doses of placebo to match both donepezil and MK-3134 PO, plus a single dose of scopolamine 0.5 mg SQ.
Drug: C: MK-3134 25 mg + Scopolamine 0.5 mg
A single dose of MK-3134 PO 25 mg, plus a single dose of scopolamine SQ 0.5 mg.
Drug: D: Donepezil 10 mg + Scopolamine 0.5 mg
A single dose of donepezil 10 mg PO, plus a single dose of scopolamine 0.5 mg SQ.
Other Names:
  • Aricept (donepezil)
Drug: E: Combo: Donepezil 10 mg + MK-3134 25 mg + Scopolamine 0.5 mg
A combination of single doses of all active drugs: donepezil 10 mg and MK-3134 25 mg PO, plus scopolamine, SQ.
Other Names:
  • Aricept (donepezil)
Experimental: E, A, C, D, B
Participants received treatment E, A, C, D, B for Periods 1, 2, 3, 4, and 5, respectively.
Drug: A: Placebo to match Donepezil and MK-3134 + Placebo to match Scopolamine
Single doses of placebo to match both donepezil and MK-3134 PO, plus a single dose of placebo to match scopolamine SQ.
Drug: B: Placebo to match Donepezil and MK-3134 + Scopolamine 0.5 mg
Single doses of placebo to match both donepezil and MK-3134 PO, plus a single dose of scopolamine 0.5 mg SQ.
Drug: C: MK-3134 25 mg + Scopolamine 0.5 mg
A single dose of MK-3134 PO 25 mg, plus a single dose of scopolamine SQ 0.5 mg.
Drug: D: Donepezil 10 mg + Scopolamine 0.5 mg
A single dose of donepezil 10 mg PO, plus a single dose of scopolamine 0.5 mg SQ.
Other Names:
  • Aricept (donepezil)
Drug: E: Combo: Donepezil 10 mg + MK-3134 25 mg + Scopolamine 0.5 mg
A combination of single doses of all active drugs: donepezil 10 mg and MK-3134 25 mg PO, plus scopolamine, SQ.
Other Names:
  • Aricept (donepezil)
Experimental: A, C, B, E, D
Participants received treatment A, C, B, E, D for Periods 1, 2, 3, 4, and 5, respectively.
Drug: A: Placebo to match Donepezil and MK-3134 + Placebo to match Scopolamine
Single doses of placebo to match both donepezil and MK-3134 PO, plus a single dose of placebo to match scopolamine SQ.
Drug: B: Placebo to match Donepezil and MK-3134 + Scopolamine 0.5 mg
Single doses of placebo to match both donepezil and MK-3134 PO, plus a single dose of scopolamine 0.5 mg SQ.
Drug: C: MK-3134 25 mg + Scopolamine 0.5 mg
A single dose of MK-3134 PO 25 mg, plus a single dose of scopolamine SQ 0.5 mg.
Drug: D: Donepezil 10 mg + Scopolamine 0.5 mg
A single dose of donepezil 10 mg PO, plus a single dose of scopolamine 0.5 mg SQ.
Other Names:
  • Aricept (donepezil)
Drug: E: Combo: Donepezil 10 mg + MK-3134 25 mg + Scopolamine 0.5 mg
A combination of single doses of all active drugs: donepezil 10 mg and MK-3134 25 mg PO, plus scopolamine, SQ.
Other Names:
  • Aricept (donepezil)
Experimental: B, D, C, A, E
Participants received treatment B, D, C, A, E for Periods 1, 2, 3, 4, and 5, respectively.
Drug: A: Placebo to match Donepezil and MK-3134 + Placebo to match Scopolamine
Single doses of placebo to match both donepezil and MK-3134 PO, plus a single dose of placebo to match scopolamine SQ.
Drug: B: Placebo to match Donepezil and MK-3134 + Scopolamine 0.5 mg
Single doses of placebo to match both donepezil and MK-3134 PO, plus a single dose of scopolamine 0.5 mg SQ.
Drug: C: MK-3134 25 mg + Scopolamine 0.5 mg
A single dose of MK-3134 PO 25 mg, plus a single dose of scopolamine SQ 0.5 mg.
Drug: D: Donepezil 10 mg + Scopolamine 0.5 mg
A single dose of donepezil 10 mg PO, plus a single dose of scopolamine 0.5 mg SQ.
Other Names:
  • Aricept (donepezil)
Drug: E: Combo: Donepezil 10 mg + MK-3134 25 mg + Scopolamine 0.5 mg
A combination of single doses of all active drugs: donepezil 10 mg and MK-3134 25 mg PO, plus scopolamine, SQ.
Other Names:
  • Aricept (donepezil)
Experimental: C, E, D, B, A
Participants received treatment C, E, D, B, A for Periods 1, 2, 3, 4, and 5, respectively.
Drug: A: Placebo to match Donepezil and MK-3134 + Placebo to match Scopolamine
Single doses of placebo to match both donepezil and MK-3134 PO, plus a single dose of placebo to match scopolamine SQ.
Drug: B: Placebo to match Donepezil and MK-3134 + Scopolamine 0.5 mg
Single doses of placebo to match both donepezil and MK-3134 PO, plus a single dose of scopolamine 0.5 mg SQ.
Drug: C: MK-3134 25 mg + Scopolamine 0.5 mg
A single dose of MK-3134 PO 25 mg, plus a single dose of scopolamine SQ 0.5 mg.
Drug: D: Donepezil 10 mg + Scopolamine 0.5 mg
A single dose of donepezil 10 mg PO, plus a single dose of scopolamine 0.5 mg SQ.
Other Names:
  • Aricept (donepezil)
Drug: E: Combo: Donepezil 10 mg + MK-3134 25 mg + Scopolamine 0.5 mg
A combination of single doses of all active drugs: donepezil 10 mg and MK-3134 25 mg PO, plus scopolamine, SQ.
Other Names:
  • Aricept (donepezil)
Experimental: D, A, E, C, B
Participants received treatment D, A, E, C, B for Periods 1, 2, 3, 4, and 5, respectively.
Drug: A: Placebo to match Donepezil and MK-3134 + Placebo to match Scopolamine
Single doses of placebo to match both donepezil and MK-3134 PO, plus a single dose of placebo to match scopolamine SQ.
Drug: B: Placebo to match Donepezil and MK-3134 + Scopolamine 0.5 mg
Single doses of placebo to match both donepezil and MK-3134 PO, plus a single dose of scopolamine 0.5 mg SQ.
Drug: C: MK-3134 25 mg + Scopolamine 0.5 mg
A single dose of MK-3134 PO 25 mg, plus a single dose of scopolamine SQ 0.5 mg.
Drug: D: Donepezil 10 mg + Scopolamine 0.5 mg
A single dose of donepezil 10 mg PO, plus a single dose of scopolamine 0.5 mg SQ.
Other Names:
  • Aricept (donepezil)
Drug: E: Combo: Donepezil 10 mg + MK-3134 25 mg + Scopolamine 0.5 mg
A combination of single doses of all active drugs: donepezil 10 mg and MK-3134 25 mg PO, plus scopolamine, SQ.
Other Names:
  • Aricept (donepezil)
Experimental: E, B, A, D, C
Participants received treatment E, B, A, D, C for Periods 1, 2, 3, 4, and 5, respectively.
Drug: A: Placebo to match Donepezil and MK-3134 + Placebo to match Scopolamine
Single doses of placebo to match both donepezil and MK-3134 PO, plus a single dose of placebo to match scopolamine SQ.
Drug: B: Placebo to match Donepezil and MK-3134 + Scopolamine 0.5 mg
Single doses of placebo to match both donepezil and MK-3134 PO, plus a single dose of scopolamine 0.5 mg SQ.
Drug: C: MK-3134 25 mg + Scopolamine 0.5 mg
A single dose of MK-3134 PO 25 mg, plus a single dose of scopolamine SQ 0.5 mg.
Drug: D: Donepezil 10 mg + Scopolamine 0.5 mg
A single dose of donepezil 10 mg PO, plus a single dose of scopolamine 0.5 mg SQ.
Other Names:
  • Aricept (donepezil)
Drug: E: Combo: Donepezil 10 mg + MK-3134 25 mg + Scopolamine 0.5 mg
A combination of single doses of all active drugs: donepezil 10 mg and MK-3134 25 mg PO, plus scopolamine, SQ.
Other Names:
  • Aricept (donepezil)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 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.
1, 2, 3, 4, 6, 8, and 12 hours relative to administration of SQ scopolamine or SQ placebo

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2007

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2007

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2007

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 12, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 12, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 13, 2010

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 6, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 5, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 3134-005
  • 2007-001894-27 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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