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)

September 18, 2018 updated by: Merck Sharp & Dohme LLC

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

4

Phase

  • 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

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PBO→MK-7.5→DON→MK-25
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.
Drug: MK-0249 7.5 mg
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
Drug: MK-0249 25 mg
5 x 5 mg tablets totaling 25 mg, single oral dose during each crossover period
Drug: Donepezil 5mg
One 5 mg tablet, single oral dose during each crossover period
Other Names:
  • Aricept
Drug: Placebo to MK-0249
Five tablets, single oral dose during each crossover period
Drug: Placebo to Donepezil
One over-encapsulated capsule, single oral dose during each crossover period
Experimental: MK-7.5→PBO→MK-25→DON
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.
Drug: MK-0249 7.5 mg
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
Drug: MK-0249 25 mg
5 x 5 mg tablets totaling 25 mg, single oral dose during each crossover period
Drug: Donepezil 5mg
One 5 mg tablet, single oral dose during each crossover period
Other Names:
  • Aricept
Drug: Placebo to MK-0249
Five tablets, single oral dose during each crossover period
Drug: Placebo to Donepezil
One over-encapsulated capsule, single oral dose during each crossover period
Experimental: DON→MK-25→PBO→MK-7.5
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.
Drug: MK-0249 7.5 mg
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
Drug: MK-0249 25 mg
5 x 5 mg tablets totaling 25 mg, single oral dose during each crossover period
Drug: Donepezil 5mg
One 5 mg tablet, single oral dose during each crossover period
Other Names:
  • Aricept
Drug: Placebo to MK-0249
Five tablets, single oral dose during each crossover period
Drug: Placebo to Donepezil
One over-encapsulated capsule, single oral dose during each crossover period
Experimental: MK-25→DON→MK-7.5→PBO
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.
Drug: MK-0249 7.5 mg
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
Drug: MK-0249 25 mg
5 x 5 mg tablets totaling 25 mg, single oral dose during each crossover period
Drug: Donepezil 5mg
One 5 mg tablet, single oral dose during each crossover period
Other Names:
  • Aricept
Drug: Placebo to MK-0249
Five tablets, single oral dose during each crossover period
Drug: Placebo to Donepezil
One over-encapsulated capsule, single oral dose during each crossover period
Experimental: PBO→MK-25→MK-7.5→DON
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.
Drug: MK-0249 7.5 mg
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
Drug: MK-0249 25 mg
5 x 5 mg tablets totaling 25 mg, single oral dose during each crossover period
Drug: Donepezil 5mg
One 5 mg tablet, single oral dose during each crossover period
Other Names:
  • Aricept
Drug: Placebo to MK-0249
Five tablets, single oral dose during each crossover period
Drug: Placebo to Donepezil
One over-encapsulated capsule, single oral dose during each crossover period
Experimental: MK-7.5→DON→PBO→MK-25
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.
Drug: MK-0249 7.5 mg
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
Drug: MK-0249 25 mg
5 x 5 mg tablets totaling 25 mg, single oral dose during each crossover period
Drug: Donepezil 5mg
One 5 mg tablet, single oral dose during each crossover period
Other Names:
  • Aricept
Drug: Placebo to MK-0249
Five tablets, single oral dose during each crossover period
Drug: Placebo to Donepezil
One over-encapsulated capsule, single oral dose during each crossover period
Experimental: DON→MK-7.5→MK-25→PBO
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.
Drug: MK-0249 7.5 mg
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
Drug: MK-0249 25 mg
5 x 5 mg tablets totaling 25 mg, single oral dose during each crossover period
Drug: Donepezil 5mg
One 5 mg tablet, single oral dose during each crossover period
Other Names:
  • Aricept
Drug: Placebo to MK-0249
Five tablets, single oral dose during each crossover period
Drug: Placebo to Donepezil
One over-encapsulated capsule, single oral dose during each crossover period
Experimental: MK-25→PBO→DON→MK-7.5
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.
Drug: MK-0249 7.5 mg
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
Drug: MK-0249 25 mg
5 x 5 mg tablets totaling 25 mg, single oral dose during each crossover period
Drug: Donepezil 5mg
One 5 mg tablet, single oral dose during each crossover period
Other Names:
  • Aricept
Drug: Placebo to MK-0249
Five tablets, single oral dose during each crossover period
Drug: Placebo to Donepezil
One over-encapsulated capsule, single oral dose during each crossover period
Experimental: PBO→DON→MK-25→MK-7.5
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.
Drug: MK-0249 7.5 mg
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
Drug: MK-0249 25 mg
5 x 5 mg tablets totaling 25 mg, single oral dose during each crossover period
Drug: Donepezil 5mg
One 5 mg tablet, single oral dose during each crossover period
Other Names:
  • Aricept
Drug: Placebo to MK-0249
Five tablets, single oral dose during each crossover period
Drug: Placebo to Donepezil
One over-encapsulated capsule, single oral dose during each crossover period
Experimental: MK-7.5→MK-25→DON→PBO
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.
Drug: MK-0249 7.5 mg
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
Drug: MK-0249 25 mg
5 x 5 mg tablets totaling 25 mg, single oral dose during each crossover period
Drug: Donepezil 5mg
One 5 mg tablet, single oral dose during each crossover period
Other Names:
  • Aricept
Drug: Placebo to MK-0249
Five tablets, single oral dose during each crossover period
Drug: Placebo to Donepezil
One over-encapsulated capsule, single oral dose during each crossover period
Experimental: DON→PBO→MK-7.5→MK-25
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.
Drug: MK-0249 7.5 mg
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
Drug: MK-0249 25 mg
5 x 5 mg tablets totaling 25 mg, single oral dose during each crossover period
Drug: Donepezil 5mg
One 5 mg tablet, single oral dose during each crossover period
Other Names:
  • Aricept
Drug: Placebo to MK-0249
Five tablets, single oral dose during each crossover period
Drug: Placebo to Donepezil
One over-encapsulated capsule, single oral dose during each crossover period
Experimental: MK-25→MK-7.5→PBO→DON
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.
Drug: MK-0249 7.5 mg
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
Drug: MK-0249 25 mg
5 x 5 mg tablets totaling 25 mg, single oral dose during each crossover period
Drug: Donepezil 5mg
One 5 mg tablet, single oral dose during each crossover period
Other Names:
  • Aricept
Drug: Placebo to MK-0249
Five tablets, single oral dose during each crossover period
Drug: Placebo to Donepezil
One over-encapsulated capsule, single oral dose during each crossover period

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: Baseline and 5-7 hours post-dose
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.
Baseline and 5-7 hours post-dose
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
Time Frame: Baseline and 5-7 hours post-dose
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.
Baseline and 5-7 hours post-dose

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time Weighted Average of the Change From Baseline After Single Dose Administration of MK-0249, Measured by GMLT in Participants With Alzheimer's Disease.
Time Frame: Baseline and 5-7 hours post-dose
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.
Baseline and 5-7 hours post-dose
Time Weighted Average of the Change From Baseline After Single Dose Administration of MK-0249, Measured by GMLT in Healthy Participants.
Time Frame: Baseline and 5-7 hours post-dose
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.
Baseline and 5-7 hours post-dose

Collaborators and Investigators

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

Sponsor

Merck Sharp & Dohme LLC

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 (Actual)

April 6, 2009

Primary Completion (Actual)

April 20, 2009

Study Completion (Actual)

April 20, 2009

Study Registration Dates

First Submitted

April 2, 2009

First Submitted That Met QC Criteria

April 2, 2009

First Posted (Estimate)

April 3, 2009

Study Record Updates

Last Update Posted (Actual)

October 17, 2018

Last Update Submitted That Met QC Criteria

September 18, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0249-023
  • MK-0249-023 (Other Identifier: Merck Sharp & Dohme Corp.)
  • 2009_572

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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