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

This study has been terminated.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00874939
First received: April 2, 2009
Last updated: May 27, 2009
Last verified: May 2009
  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:


Further study details as provided by Merck Sharp & Dohme Corp.:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  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 September 22, 2014