Computerized Cognition Testing in Participants With Mild Alzheimer's Disease (AD) Treated With Donepezil (MK-0000-318)
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Intervention: Placebo; Donepezil; Donepezil
Intervention description: Placebo for donepezil hydrochloride capsule; 5 mg donepezil hydrochloride capsule.; 10 mg donepezil hydrochloride capsule.
Intervention MeSH terms: Donepezil
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 36.0
Sex: All
Minimum age: 55 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      This study aims to determine whether the Cogstate testing battery can detect improvements in
      cognitive function in participants with mild AD. The primary hypothesis is that for one of
      the Cogstate battery tests, One Card Learning (OCL), the standard deviation associated with
      the change from baseline in OCL measurements after 12 weeks of donepezil and placebo
      treatments is =<0.1
    

Eligibility criteria:

        Inclusion Criteria:

          -  Meets listed criteria for a diagnosis of probable AD

          -  Has a clearly documented history either in medical records or from an informant of
             cognitive decline over at least 6 months

          -  Has a reliable partner/caregiver who is willing to provide input by participating in
             assessments

          -  Has results of a physical examination and clinical laboratory tests within normal or
             clinically acceptable limits

          -  Can communicate with trial staff acceptably, possesses the ability to respond verbally
             to questions, follow instructions, complete questionnaires, and adhere to visit
             schedules

          -  Can read at a 9th grade level or equivalent, and has an acceptable history of academic
             achievement and/or employment

          -  Has a magnetic resonance imaging (MRI) scan that rules out non-AD conditions
             contributing to cognitive dysfunction

          -  Capably performs the CogState screening battery

          -  Has adequate visual acuity and function

          -  Females are not of childbearing potential

        Exclusion Criteria:

          -  Has ever received acetylcholinesterase inhibitors, memantine, or other symptomatic AD
             treatment including approved medical foods

          -  Has an uncontrolled, clinically significant medical condition or situation within 3
             months prior to screening

          -  Has had major surgery within 3 months prior to screening

          -  Has tested positive for human immunodeficiency virus (HIV) or has evidence of an
             active hepatitis B infection

          -  Has a history of malignancy within the prior 5 years

          -  Is unwilling or ineligible to undergo an MRI scan

          -  Has a history of clinically important structural changes on screening MRI scan

          -  Has a clinically important history of stroke or a diagnosis of vascular dementia

          -  Has evidence of a clinically relevant non-AD neurological disorder

          -  Has a history of head trauma, or serious infectious disease affecting the brain within
             the prior 3-5 years

          -  Has evidence of a clinically relevant or unstable psychiatric disorder, excepting
             major depression in remission

          -  Has evidence of a current episode of major depression

          -  Has evidence of Type 4 or Type 5 Suicidal Ideation

          -  Has clinically significant vitamin B12 or folate deficiency in the 6 months prior to
             screening

          -  Is pregnant, attempting to become pregnant or is nursing children

          -  Has used any investigational drug or participated in any other clinical trial within
             the prior 30 days

          -  Has a history of alcoholism or drug dependency/abuse within the last 5 years

          -  Has a relative contraindication to donepezil including sick sinus syndrome, third
             degree heart block, active gastrointestinal (GI) bleeding, Zollinger-Ellison syndrome,
             uncontrolled peptic ulcer disease, or uncontrolled asthma