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)

NCT ID: NCT00874939

Last Updated: 2018-10-17

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-04-06
• Study Completion Date: 2009-04-20

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.

Conditions

Alzheimer's Disease; Dementia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

MK-0249 7.5 mg

Intervention Type: DRUG

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

MK-0249 25 mg

Intervention Type: DRUG

5 x 5 mg tablets totaling 25 mg, single oral dose during each crossover period

Donepezil 5mg

Intervention Type: DRUG

One 5 mg tablet, single oral dose during each crossover period

Placebo to MK-0249

Intervention Type: DRUG

Five tablets, single oral dose during each crossover period

Placebo to Donepezil

Intervention Type: DRUG

One over-encapsulated capsule, single oral dose during each crossover period

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.

Group Type: EXPERIMENTAL

MK-0249 7.5 mg

Intervention Type: DRUG

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

MK-0249 25 mg

Intervention Type: DRUG

5 x 5 mg tablets totaling 25 mg, single oral dose during each crossover period

Donepezil 5mg

Intervention Type: DRUG

One 5 mg tablet, single oral dose during each crossover period

Placebo to MK-0249

Intervention Type: DRUG

Five tablets, single oral dose during each crossover period

Placebo to Donepezil

Intervention Type: DRUG

One over-encapsulated capsule, single oral dose during each crossover period

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.

Group Type: EXPERIMENTAL

MK-0249 7.5 mg

Intervention Type: DRUG

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

MK-0249 25 mg

Intervention Type: DRUG

5 x 5 mg tablets totaling 25 mg, single oral dose during each crossover period

Donepezil 5mg

Intervention Type: DRUG

One 5 mg tablet, single oral dose during each crossover period

Placebo to MK-0249

Intervention Type: DRUG

Five tablets, single oral dose during each crossover period

Placebo to Donepezil

Intervention Type: DRUG

One over-encapsulated capsule, single oral dose during each crossover period

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.

Group Type: EXPERIMENTAL

MK-0249 7.5 mg

Intervention Type: DRUG

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

MK-0249 25 mg

Intervention Type: DRUG

5 x 5 mg tablets totaling 25 mg, single oral dose during each crossover period

Donepezil 5mg

Intervention Type: DRUG

One 5 mg tablet, single oral dose during each crossover period

Placebo to MK-0249

Intervention Type: DRUG

Five tablets, single oral dose during each crossover period

Placebo to Donepezil

Intervention Type: DRUG

One over-encapsulated capsule, single oral dose during each crossover period

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.

Group Type: EXPERIMENTAL

MK-0249 7.5 mg

Intervention Type: DRUG

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

MK-0249 25 mg

Intervention Type: DRUG

5 x 5 mg tablets totaling 25 mg, single oral dose during each crossover period

Donepezil 5mg

Intervention Type: DRUG

One 5 mg tablet, single oral dose during each crossover period

Placebo to MK-0249

Intervention Type: DRUG

Five tablets, single oral dose during each crossover period

Placebo to Donepezil

Intervention Type: DRUG

One over-encapsulated capsule, single oral dose during each crossover period

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.

Group Type: EXPERIMENTAL

MK-0249 7.5 mg

Intervention Type: DRUG

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

MK-0249 25 mg

Intervention Type: DRUG

5 x 5 mg tablets totaling 25 mg, single oral dose during each crossover period

Donepezil 5mg

Intervention Type: DRUG

One 5 mg tablet, single oral dose during each crossover period

Placebo to MK-0249

Intervention Type: DRUG

Five tablets, single oral dose during each crossover period

Placebo to Donepezil

Intervention Type: DRUG

One over-encapsulated capsule, single oral dose during each crossover period

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.

Group Type: EXPERIMENTAL

MK-0249 7.5 mg

Intervention Type: DRUG

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

MK-0249 25 mg

Intervention Type: DRUG

5 x 5 mg tablets totaling 25 mg, single oral dose during each crossover period

Donepezil 5mg

Intervention Type: DRUG

One 5 mg tablet, single oral dose during each crossover period

Placebo to MK-0249

Intervention Type: DRUG

Five tablets, single oral dose during each crossover period

Placebo to Donepezil

Intervention Type: DRUG

One over-encapsulated capsule, single oral dose during each crossover period

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.

Group Type: EXPERIMENTAL

MK-0249 7.5 mg

Intervention Type: DRUG

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

MK-0249 25 mg

Intervention Type: DRUG

5 x 5 mg tablets totaling 25 mg, single oral dose during each crossover period

Donepezil 5mg

Intervention Type: DRUG

One 5 mg tablet, single oral dose during each crossover period

Placebo to MK-0249

Intervention Type: DRUG

Five tablets, single oral dose during each crossover period

Placebo to Donepezil

Intervention Type: DRUG

One over-encapsulated capsule, single oral dose during each crossover period

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.

Group Type: EXPERIMENTAL

MK-0249 7.5 mg

Intervention Type: DRUG

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

MK-0249 25 mg

Intervention Type: DRUG

5 x 5 mg tablets totaling 25 mg, single oral dose during each crossover period

Donepezil 5mg

Intervention Type: DRUG

One 5 mg tablet, single oral dose during each crossover period

Placebo to MK-0249

Intervention Type: DRUG

Five tablets, single oral dose during each crossover period

Placebo to Donepezil

Intervention Type: DRUG

One over-encapsulated capsule, single oral dose during each crossover period

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.

Group Type: EXPERIMENTAL

MK-0249 7.5 mg

Intervention Type: DRUG

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

MK-0249 25 mg

Intervention Type: DRUG

5 x 5 mg tablets totaling 25 mg, single oral dose during each crossover period

Donepezil 5mg

Intervention Type: DRUG

One 5 mg tablet, single oral dose during each crossover period

Placebo to MK-0249

Intervention Type: DRUG

Five tablets, single oral dose during each crossover period

Placebo to Donepezil

Intervention Type: DRUG

One over-encapsulated capsule, single oral dose during each crossover period

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.

Group Type: EXPERIMENTAL

MK-0249 7.5 mg

Intervention Type: DRUG

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

MK-0249 25 mg

Intervention Type: DRUG

5 x 5 mg tablets totaling 25 mg, single oral dose during each crossover period

Donepezil 5mg

Intervention Type: DRUG

One 5 mg tablet, single oral dose during each crossover period

Placebo to MK-0249

Intervention Type: DRUG

Five tablets, single oral dose during each crossover period

Placebo to Donepezil

Intervention Type: DRUG

One over-encapsulated capsule, single oral dose during each crossover period

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.

Group Type: EXPERIMENTAL

MK-0249 7.5 mg

Intervention Type: DRUG

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

MK-0249 25 mg

Intervention Type: DRUG

5 x 5 mg tablets totaling 25 mg, single oral dose during each crossover period

Donepezil 5mg

Intervention Type: DRUG

One 5 mg tablet, single oral dose during each crossover period

Placebo to MK-0249

Intervention Type: DRUG

Five tablets, single oral dose during each crossover period

Placebo to Donepezil

Intervention Type: DRUG

One over-encapsulated capsule, single oral dose during each crossover period

Interventions

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

Intervention Type: DRUG

MK-0249 25 mg

5 x 5 mg tablets totaling 25 mg, single oral dose during each crossover period

Intervention Type: DRUG

Donepezil 5mg

One 5 mg tablet, single oral dose during each crossover period

Intervention Type: DRUG

Placebo to MK-0249

Five tablets, single oral dose during each crossover period

Intervention Type: DRUG

Placebo to Donepezil

One over-encapsulated capsule, single oral dose during each crossover period

Intervention Type: DRUG

Other Intervention Names

Aricept

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Other Identifiers

MK-0249-023

Identifier Type: OTHER

Identifier Source: secondary_id

2009_572

Identifier Type: -

Identifier Source: secondary_id

0249-023

Identifier Type: -

Identifier Source: org_study_id