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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


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


Minimum age: 55 Years. Maximum age: 85 Years. Gender(s): Both.


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


- 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


- 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

Page last updated: August 20, 2015

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