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)

Dementia Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00874939
• Other study ID #: 0249-023
• Secondary ID: MK-0249-0232009_
• Status: Terminated
• Phase: Phase 1
• Start date: April 6, 2009
• Est. completion date: April 20, 2009

Study information

• Verified date: September 2018
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: April 20, 2009
• Est. primary completion date: April 20, 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease
• Dementia

Intervention

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
• MK-0249 25 mg
5 x 5 mg tablets totaling 25 mg, single oral dose during each crossover period
• Donepezil 5mg
One 5 mg tablet, single oral dose during each crossover period
• Placebo to MK-0249
Five tablets, single oral dose during each crossover period
• Placebo to Donepezil
One over-encapsulated capsule, single oral dose during each crossover period

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline and 5-7 hours post-dose
Primary	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.	Baseline and 5-7 hours post-dose
Secondary	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.	Baseline and 5-7 hours post-dose
Secondary	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.	Baseline and 5-7 hours post-dose