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)
Condition: Alzheimer's Disease; Dementia
MeSH terms: Alzheimer Disease
Intervention: MK-0249 7.5 mg; MK-0249 25 mg; Donepezil 5mg; Placebo to MK-0249; Placebo to Donepezil
Intervention description: 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; 5 x 5 mg tablets totaling 25 mg, single oral dose during each crossover period; One 5 mg tablet, single oral dose during each crossover period; Five tablets, single oral dose during each crossover period; One over-encapsulated capsule, single oral dose during each crossover period
Intervention MeSH terms: Donepezil
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 4.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

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.
    

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