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A Study to Evaluate the Effects of MK-0249 and an Alzheimer's Disease Medication on Cognitive Function in Adults With Alzheimer's Disease (MK-0249-023)

Primary Purpose

Alzheimer's Disease, Dementia

Status
Terminated
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
MK-0249 7.5 mg
MK-0249 25 mg
Donepezil 5mg
Placebo to MK-0249
Placebo to Donepezil
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer's Disease

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Patient Specific:

  • Female is not of reproductive potential
  • Male who has a female partner(s) of child bearing potential, agrees to use acceptable method of contraception during the study
  • Has at least 10 years of education or work history
  • Has been a nonsmoker or has not used nicotine for at least 6 months
  • Has a diagnosis of mild-to-moderate Alzheimer's Disease
  • Has a reliable caregiver who consents to accompany the patient to all clinic visits, provide information to the study staff, and return for follow-up visits and procedures

Healthy Elderly Volunteer Specific:

  • Is in good general health
  • Has no clinically significant abnormality on electrocardiogram (ECG)

Exclusion Criteria:

Participant Specific:

  • Has a history of a neurological disorder other than Alzheimer's disease
  • Is living in a nursing home
  • Has a history of stroke
  • Has a history of psychotic disorder, an active major depressive disorder, or history of schizophrenia
  • Has a history of a sleep disorder
  • Has a history of a cardiovascular disorder
  • Has a history of malignancy
  • Is participating or has participated in a study with an investigational compound, device, or vaccine for Alzheimer's disease
  • Consumes greater than 6 servings of caffeine (coffee, tea or cola etc.) per day
  • Consumes greater than 3 alcoholic beverages per day
  • Has had major surgery, donated or loss blood in past 8 weeks

Healthy Elderly Volunteer Specific:

  • Is mentally or legally incapacitated, has significant emotional problems, or has a history of a psychiatric disorder over the last 5-10 years

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm 6

    Arm 7

    Arm 8

    Arm 9

    Arm 10

    Arm 11

    Arm 12

    Arm Type

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Arm Label

    PBO→MK-7.5→DON→MK-25

    MK-7.5→PBO→MK-25→DON

    DON→MK-25→PBO→MK-7.5

    MK-25→DON→MK-7.5→PBO

    PBO→MK-25→MK-7.5→DON

    MK-7.5→DON→PBO→MK-25

    DON→MK-7.5→MK-25→PBO

    MK-25→PBO→DON→MK-7.5

    PBO→DON→MK-25→MK-7.5

    MK-7.5→MK-25→DON→PBO

    DON→PBO→MK-7.5→MK-25

    MK-25→MK-7.5→PBO→DON

    Arm Description

    Treatment by single oral dose with Placebo (PBO) in the first crossover period; MK-0249 7.5 mg (MK-7.5) in the second crossover period; Donepezil 5 mg (DON) in the third crossover period; and MK-0249 25 mg (MK-25) in the fourth crossover period.

    Treatment by single oral dose with MK-0249 7.5 mg in the first crossover period; Placebo in the second crossover period; MK-0249 25 mg in the third crossover period; and Donepezil 5 mg in the fourth crossover period.

    Treatment by single oral dose with Donepezil 5 mg in the first crossover period; MK-0249 25 mg in the second crossover period; Placebo in the third crossover period; and MK-0249 7.5 mg in the fourth crossover period.

    Treatment by single oral dose with MK-0249 25 mg in the first crossover period; Donepezil 5 mg in the second crossover period; MK-0249 7.5 mg in the third crossover period; and Placebo in the fourth crossover period.

    Treatment by single oral dose with Placebo in the first crossover period; MK-0249 25 mg in the second crossover period; MK-0249 7.5 mg in the third crossover period; and Donepezil 5 mg in the fourth crossover period.

    Treatment by single oral dose with MK-0249 7.5 mg in the first crossover period; Donepezil 5 mg in the second crossover period; Placebo in the third crossover period; and MK-0249 25 mg in the fourth crossover period.

    Treatment by single oral dose with Donepezil 5 mg in the first crossover period; MK-0249 7.5 mg in the second crossover period; MK-0249 25 mg in the third crossover period; and Placebo in the fourth crossover period.

    Treatment by single oral dose with MK-0249 25 mg in the first crossover period; Placebo in the second crossover period; Donepezil 5 mg in the third crossover period; and MK-0249 7.5 mg in the fourth crossover period.

    Treatment by single oral dose with Placebo in the first crossover period; Donepezil 5 mg in the second crossover period; MK-0249 25 mg in the third crossover period; and MK-0249 7.5 mg in the fourth crossover period.

    Treatment by single oral dose with MK-0249 7.5 mg in the first crossover period; MK-0249 25 mg in the second crossover period; Donepezil 5 mg in the third crossover period; and Placebo in the fourth crossover period.

    Treatment by single oral dose with Donepezil 5 mg in the first crossover period; Placebo in the second crossover period; MK-0249 7.5 mg in the third crossover period; and MK-0249 25 mg in the fourth crossover period.

    Treatment by single oral dose with MK-0249 25 mg in the first crossover period; MK-0249 7.5 mg in the second crossover period; Placebo in the third crossover period; and Donepezil 5 mg in the fourth crossover period.

    Outcomes

    Primary Outcome Measures

    Time Weighted Average of the Change From Baseline After Single Dose Administration of Donepezil 5 mg or Placebo, Measured by Groton Maze Learning Test (GMLT) in Participants With Alzheimer's Disease
    The GMLT measures executive function and spatial problem solving on a computer touch screen where participants learn a hidden pathway through a maze consisting of a 10 x 10 grid of tiles. The number of errors made for five consecutive trials at a single session is totaled, where lower number of errors indicates better performance. A change from baseline that is positive indicates improved function.
    Time Weighted Average of the Change From Baseline After Single Dose Administration of Donepezil 5 mg or Placebo, Measured by Groton Maze Learning Test (GMLT) in Healthy Participants
    The GMLT measures executive function and spatial problem solving on a computer touch screen where participants learn a hidden pathway through a maze consisting of a 10 x 10 grid of tiles. The number of errors made for five consecutive trials at a single session is totaled, where lower number of errors indicates better performance. A change from baseline that is positive indicates improved function.

    Secondary Outcome Measures

    Time Weighted Average of the Change From Baseline After Single Dose Administration of MK-0249, Measured by GMLT in Participants With Alzheimer's Disease.
    The GMLT measures executive function and spatial problem solving on a computer touch screen where participants learn a hidden pathway through a maze consisting of a 10 x 10 grid of tiles. The number of errors made for five consecutive trials at a single session is totaled, where lower number of errors indicates better performance. A change from baseline that is positive indicates improved function.
    Time Weighted Average of the Change From Baseline After Single Dose Administration of MK-0249, Measured by GMLT in Healthy Participants.
    The GMLT measures executive function and spatial problem solving on a computer touch screen where participants learn a hidden pathway through a maze consisting of a 10 x 10 grid of tiles. The number of errors made for five consecutive trials at a single session is totaled, where lower number of errors indicates better performance. A change from baseline that is positive indicates improved function.

    Full Information

    First Posted
    April 2, 2009
    Last Updated
    September 18, 2018
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00874939
    Brief Title
    A Study to Evaluate the Effects of MK-0249 and an Alzheimer's Disease Medication on Cognitive Function in Adults With Alzheimer's Disease (MK-0249-023)
    Official Title
    A Randomized Clinical Trial To Evaluate the Single Dose Acute Effects of MK-0249 and Donepezil On Cognitive Function In Adult Patients With Alzheimer's Disease
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2018
    Overall Recruitment Status
    Terminated
    Study Start Date
    April 6, 2009 (Actual)
    Primary Completion Date
    April 20, 2009 (Actual)
    Study Completion Date
    April 20, 2009 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Merck Sharp & Dohme LLC

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This study will evaluate acute symptomatic improvements in cognitive performance in healthy elderly participants with mild-to-moderate Alzheimer's disease. A four-week pilot study will first evaluate the CogState computerized cognitive battery in participants who are not receiving treatment. After completion of the pilot study, participants will be randomized to receive Placebo, Donepezil 5 mg, MK-0249 7.5 mg, and MK-0249 25 mg. After each drug administration the participants will be given the CogState computerized cognitive battery to assess cognitive performance. The primary hypotheses are that cognitive performance in participants with Alzheimer's disease, or in healthy participants, is improved by the administration of a single oral 5 mg dose of Donepezil as compared to placebo.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Alzheimer's Disease, Dementia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    4 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    PBO→MK-7.5→DON→MK-25
    Arm Type
    Experimental
    Arm Description
    Treatment by single oral dose with Placebo (PBO) in the first crossover period; MK-0249 7.5 mg (MK-7.5) in the second crossover period; Donepezil 5 mg (DON) in the third crossover period; and MK-0249 25 mg (MK-25) in the fourth crossover period.
    Arm Title
    MK-7.5→PBO→MK-25→DON
    Arm Type
    Experimental
    Arm Description
    Treatment by single oral dose with MK-0249 7.5 mg in the first crossover period; Placebo in the second crossover period; MK-0249 25 mg in the third crossover period; and Donepezil 5 mg in the fourth crossover period.
    Arm Title
    DON→MK-25→PBO→MK-7.5
    Arm Type
    Experimental
    Arm Description
    Treatment by single oral dose with Donepezil 5 mg in the first crossover period; MK-0249 25 mg in the second crossover period; Placebo in the third crossover period; and MK-0249 7.5 mg in the fourth crossover period.
    Arm Title
    MK-25→DON→MK-7.5→PBO
    Arm Type
    Experimental
    Arm Description
    Treatment by single oral dose with MK-0249 25 mg in the first crossover period; Donepezil 5 mg in the second crossover period; MK-0249 7.5 mg in the third crossover period; and Placebo in the fourth crossover period.
    Arm Title
    PBO→MK-25→MK-7.5→DON
    Arm Type
    Experimental
    Arm Description
    Treatment by single oral dose with Placebo in the first crossover period; MK-0249 25 mg in the second crossover period; MK-0249 7.5 mg in the third crossover period; and Donepezil 5 mg in the fourth crossover period.
    Arm Title
    MK-7.5→DON→PBO→MK-25
    Arm Type
    Experimental
    Arm Description
    Treatment by single oral dose with MK-0249 7.5 mg in the first crossover period; Donepezil 5 mg in the second crossover period; Placebo in the third crossover period; and MK-0249 25 mg in the fourth crossover period.
    Arm Title
    DON→MK-7.5→MK-25→PBO
    Arm Type
    Experimental
    Arm Description
    Treatment by single oral dose with Donepezil 5 mg in the first crossover period; MK-0249 7.5 mg in the second crossover period; MK-0249 25 mg in the third crossover period; and Placebo in the fourth crossover period.
    Arm Title
    MK-25→PBO→DON→MK-7.5
    Arm Type
    Experimental
    Arm Description
    Treatment by single oral dose with MK-0249 25 mg in the first crossover period; Placebo in the second crossover period; Donepezil 5 mg in the third crossover period; and MK-0249 7.5 mg in the fourth crossover period.
    Arm Title
    PBO→DON→MK-25→MK-7.5
    Arm Type
    Experimental
    Arm Description
    Treatment by single oral dose with Placebo in the first crossover period; Donepezil 5 mg in the second crossover period; MK-0249 25 mg in the third crossover period; and MK-0249 7.5 mg in the fourth crossover period.
    Arm Title
    MK-7.5→MK-25→DON→PBO
    Arm Type
    Experimental
    Arm Description
    Treatment by single oral dose with MK-0249 7.5 mg in the first crossover period; MK-0249 25 mg in the second crossover period; Donepezil 5 mg in the third crossover period; and Placebo in the fourth crossover period.
    Arm Title
    DON→PBO→MK-7.5→MK-25
    Arm Type
    Experimental
    Arm Description
    Treatment by single oral dose with Donepezil 5 mg in the first crossover period; Placebo in the second crossover period; MK-0249 7.5 mg in the third crossover period; and MK-0249 25 mg in the fourth crossover period.
    Arm Title
    MK-25→MK-7.5→PBO→DON
    Arm Type
    Experimental
    Arm Description
    Treatment by single oral dose with MK-0249 25 mg in the first crossover period; MK-0249 7.5 mg in the second crossover period; Placebo in the third crossover period; and Donepezil 5 mg in the fourth crossover period.
    Intervention Type
    Drug
    Intervention Name(s)
    MK-0249 7.5 mg
    Intervention Description
    4 tablets (1 x 0.5 mg + 2 x 1 mg + 1 x 5 mg) totaling 7.5 mg, single oral dose during each crossover period
    Intervention Type
    Drug
    Intervention Name(s)
    MK-0249 25 mg
    Intervention Description
    5 x 5 mg tablets totaling 25 mg, single oral dose during each crossover period
    Intervention Type
    Drug
    Intervention Name(s)
    Donepezil 5mg
    Other Intervention Name(s)
    Aricept
    Intervention Description
    One 5 mg tablet, single oral dose during each crossover period
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo to MK-0249
    Intervention Description
    Five tablets, single oral dose during each crossover period
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo to Donepezil
    Intervention Description
    One over-encapsulated capsule, single oral dose during each crossover period
    Primary Outcome Measure Information:
    Title
    Time Weighted Average of the Change From Baseline After Single Dose Administration of Donepezil 5 mg or Placebo, Measured by Groton Maze Learning Test (GMLT) in Participants With Alzheimer's Disease
    Description
    The GMLT measures executive function and spatial problem solving on a computer touch screen where participants learn a hidden pathway through a maze consisting of a 10 x 10 grid of tiles. The number of errors made for five consecutive trials at a single session is totaled, where lower number of errors indicates better performance. A change from baseline that is positive indicates improved function.
    Time Frame
    Baseline and 5-7 hours post-dose
    Title
    Time Weighted Average of the Change From Baseline After Single Dose Administration of Donepezil 5 mg or Placebo, Measured by Groton Maze Learning Test (GMLT) in Healthy Participants
    Description
    The GMLT measures executive function and spatial problem solving on a computer touch screen where participants learn a hidden pathway through a maze consisting of a 10 x 10 grid of tiles. The number of errors made for five consecutive trials at a single session is totaled, where lower number of errors indicates better performance. A change from baseline that is positive indicates improved function.
    Time Frame
    Baseline and 5-7 hours post-dose
    Secondary Outcome Measure Information:
    Title
    Time Weighted Average of the Change From Baseline After Single Dose Administration of MK-0249, Measured by GMLT in Participants With Alzheimer's Disease.
    Description
    The GMLT measures executive function and spatial problem solving on a computer touch screen where participants learn a hidden pathway through a maze consisting of a 10 x 10 grid of tiles. The number of errors made for five consecutive trials at a single session is totaled, where lower number of errors indicates better performance. A change from baseline that is positive indicates improved function.
    Time Frame
    Baseline and 5-7 hours post-dose
    Title
    Time Weighted Average of the Change From Baseline After Single Dose Administration of MK-0249, Measured by GMLT in Healthy Participants.
    Description
    The GMLT measures executive function and spatial problem solving on a computer touch screen where participants learn a hidden pathway through a maze consisting of a 10 x 10 grid of tiles. The number of errors made for five consecutive trials at a single session is totaled, where lower number of errors indicates better performance. A change from baseline that is positive indicates improved function.
    Time Frame
    Baseline and 5-7 hours post-dose

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Patient Specific: Female is not of reproductive potential Male who has a female partner(s) of child bearing potential, agrees to use acceptable method of contraception during the study Has at least 10 years of education or work history Has been a nonsmoker or has not used nicotine for at least 6 months Has a diagnosis of mild-to-moderate Alzheimer's Disease Has a reliable caregiver who consents to accompany the patient to all clinic visits, provide information to the study staff, and return for follow-up visits and procedures Healthy Elderly Volunteer Specific: Is in good general health Has no clinically significant abnormality on electrocardiogram (ECG) Exclusion Criteria: Participant Specific: Has a history of a neurological disorder other than Alzheimer's disease Is living in a nursing home Has a history of stroke Has a history of psychotic disorder, an active major depressive disorder, or history of schizophrenia Has a history of a sleep disorder Has a history of a cardiovascular disorder Has a history of malignancy Is participating or has participated in a study with an investigational compound, device, or vaccine for Alzheimer's disease Consumes greater than 6 servings of caffeine (coffee, tea or cola etc.) per day Consumes greater than 3 alcoholic beverages per day Has had major surgery, donated or loss blood in past 8 weeks Healthy Elderly Volunteer Specific: Is mentally or legally incapacitated, has significant emotional problems, or has a history of a psychiatric disorder over the last 5-10 years
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Director
    Organizational Affiliation
    Merck Sharp & Dohme LLC
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
    IPD Sharing URL
    http://engagezone.msd.com/ds_documentation.php

    Learn more about this trial

    A Study to Evaluate the Effects of MK-0249 and an Alzheimer's Disease Medication on Cognitive Function in Adults With Alzheimer's Disease (MK-0249-023)

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