Computerized Cognition Testing in Participants With Mild Alzheimer's Disease (AD) Treated With Donepezil (MK-0000-318)
Status: | Recruiting |
---|---|
Conditions: | Alzheimer Disease |
Therapuetic Areas: | Neurology |
Healthy: | No |
Age Range: | 55 - 85 |
Updated: | 3/12/2016 |
Start Date: | April 2014 |
End Date: | August 2016 |
Contact: | Toll Free Number |
Phone: | 1-888-577-8839 |
A Clinical Trial to Assess Cognitive Function by Repeated Computerized Testing in Patients With Mild Alzheimer's Disease Treated With Donepezil
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
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
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
We found this trial at
5
sites
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials