A Study to Evaluate the Effects of MK0249 and an Alzheimer's Disease Medication on Cognitive Function in Adults With Alzheimer's Disease - Full Text View

Purpose

This study will evaluate acute symptomatic improvements in cognitive performance in healthy elderly subjects and patients 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, patients will be randomized to receive Placebo, Donepezil 5 mg, MK0249 7.5 mg, and MK0249 25 mg. After each drug administration the patients will be given the CogState computerized cognitive battery to assess cognitive performance.

Condition	Intervention	Phase
Alzheimer's Disease Dementia	Drug: MK0249 Drug: Comparator: MK0249 Drug: Comparator: Donepezil Drug: Comparator: Placebo to MK0249 Drug: Comparator: Placebo to donepezil	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	A Randomized Clinical Trial To Evaluate the Single Dose Acute Effects of MK0249 and Donepezil On Cognitive Function In Adult Patients With Alzheimer's Disease

Resource links provided by NLM:

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease Dementia

Drug Information available for: Donepezil hydrochloride Donepezil

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

Improved cognitive performance after single dose administration of donepezil 5 mg, measured by CogState computerized cognitive battery [ Time Frame: 5-7 hours post dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Improved cognitive performance after single dose administration of MK0249, measured by Groton Maze Learning Task [ Time Frame: 5-7 hours post dose ] [ Designated as safety issue: No ]

Estimated Enrollment:	44
Study Start Date:	May 2009
Study Completion Date:	May 2009
Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: A MK0249 placebo and donepezil placebo	Drug: Comparator: Placebo to MK0249 0 mg tablets, single oral dose Drug: Comparator: Placebo to donepezil 0 mg over-encapsulated capsule, single oral dose
Experimental: B MK0249 7.5 mg and donepezil placebo	Drug: MK0249 7.5 mg tablets, single oral dose Drug: Comparator: Placebo to donepezil 0 mg over-encapsulated capsule, single oral dose
Experimental: C MK0249 placebo and donepezil 5 mg	Drug: Comparator: Donepezil 5 mg over-encapsulated capsule, single oral dose Other Name: Aricept Drug: Comparator: Placebo to MK0249 0 mg tablets, single oral dose
Experimental: D MK0249 25 mg and donepezil placebo	Drug: Comparator: MK0249 25 mg tablets, single oral dose Drug: Comparator: Placebo to donepezil 0 mg over-encapsulated capsule, single oral dose

Eligibility

Ages Eligible for Study:	65 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Patient Specific:

Female subject is not of reproductive potential
Male subject who has a female partner(s) of child bearing potential, agrees to use acceptable method of contraception during the study
Subject has at least 10 years of education or work history
Subject has been a nonsmoker or has not used nicotine for at least 6 months
Subject has a diagnosis of mild-to-moderate Alzheimer's Disease
Subject 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:

Subject is in good general health
Subject has no clinically significant abnormality on electrocardiogram (ECG)

Exclusion Criteria:

Patient Specific:

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

Healthy Elderly Volunteer Specific:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00874939

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

No publications provided

Responsible Party:	Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
ClinicalTrials.gov Identifier:	NCT00874939 History of Changes
Other Study ID Numbers:	2009_572, MK0249-023
Study First Received:	April 2, 2009
Last Updated:	May 27, 2009
Health Authority:	India: Ministry of Health

Additional relevant MeSH terms:

Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Donepezil

Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 13, 2013