Computerized Cognition Testing in Participants With Mild Alzheimer's Disease (AD) Treated With Donepezil (MK-0000-318)
Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Alzheimer's Disease
Intervention: Placebo (Drug); Donepezil (Drug); Donepezil (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Merck Sharp & Dohme Corp. Official(s) and/or principal investigator(s):
Medical Director, Study Director, Affiliation: Merck Sharp & Dohme Corp.
Overall contact:
Toll Free Number, Phone: 1-888-577-8839
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 the standard
deviation associated with the change from baseline in average One Card Learning (OCL)
repeated measurements after 12 weeks of donepezil treatment is =<0. 1
Clinical Details
Official title: A Clinical Trial to Assess Cognitive Function by Repeated Computerized Testing in Patients With Mild Alzheimer's Disease Treated With Donepezil
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Diagnostic
Primary outcome: Change from baseline in average OCL measurement over 12 weeks of donepezil treatment
Secondary outcome: Change from week 4 in the proportion of correct responses in the OCL task after 12 weeks of donepezil treatment
Eligibility
Minimum age: 55 Years.
Maximum age: 85 Years.
Gender(s): Both.
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
Locations and Contacts
Toll Free Number, Phone: 1-888-577-8839
Call for Information (Investigational Site 0002), Leesburg, Florida 34748, United States; Recruiting
Call for Information (Investigational Site 0004), Orlando, Florida 32806, United States; Recruiting
Call for Information (Investigational Site 0005), Decatur, Georgia 30030, United States; Recruiting
Call for Information (Investigational Site 0001), Baton Rouge, Louisiana 70808, United States; Recruiting
Call for Information (Investigational Site 0003), Toms River, New Jersey 08755, United States; Recruiting
Call for Information (Investigational Site 0006), Oklahoma City, Oklahoma 73112, United States; Recruiting
Call for Information (Investigational Site 0007), Reading, Pennsylvania 19604, United States; Recruiting
Additional Information
Starting date: April 2014
Last updated: July 22, 2015
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