Back to resultsComputerized Cognition Testing in Participants With Mild Alzheimer's Disease (AD) Treated With Donepezil (MK-0000-318)
Primary Purpose
Alzheimer's Disease
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Placebo
Donepezil
Donepezil
Sponsored by
About this trial
This is an interventional diagnostic trial for Alzheimer's Disease
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo
Donepezil
Arm Description
Placebo for donepezil hydrochloride capsule administered orally once a day for 16 weeks.
During the first 4 weeks, participants received placebo for donepezil. Over the following 2 weeks, participants were treated with donepezil at 5 mg per day. Then, over the remaining 10 weeks were titrated to up to 10 mg per day donepezil based on tolerability.
Outcomes
Primary Outcome Measures
One-card Learning (OCL) Measurement Over 12 Weeks of Treatment
OCL is one of the Cogstate battery of tests, and is a continuous visual recognition task that assesses visual recognition, memory and attention using a pattern separation algorithm. OCL is a score defined as the arcsine transformation of the square root of the proportion of correct responses to 80 OCL questions. The score ranges from 0 to 1.5708 where a higher score means better performance.
Secondary Outcome Measures
Percentage of Correct Responses in the OCL Task Over 12 Weeks of Treatment
OCL is one of the Cogstate battery of tests, and is a continuous visual recognition task that assesses visual recognition, memory and attention using a pattern separation algorithm. The percentage of correct responses to 80 OCL questions is defined as the number of correct responses x 100 divided by the number of total responses; and ranges from 0 to 100, where 100 is best, and 0 is the worst outcome.
Full Information
NCT ID
NCT02064920
First Posted
February 14, 2014
Last Updated
September 14, 2018
Sponsor
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT02064920
Brief Title
Computerized Cognition Testing in Participants With Mild Alzheimer's Disease (AD) Treated With Donepezil (MK-0000-318)
Official Title
A Clinical Trial to Assess Cognitive Function by Repeated Computerized Testing in Patients With Mild Alzheimer's Disease Treated With Donepezil
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
April 22, 2014 (Actual)
Primary Completion Date
July 13, 2016 (Actual)
Study Completion Date
July 13, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo for donepezil hydrochloride capsule administered orally once a day for 16 weeks.
Arm Title
Donepezil
Arm Type
Experimental
Arm Description
During the first 4 weeks, participants received placebo for donepezil. Over the following 2 weeks, participants were treated with donepezil at 5 mg per day. Then, over the remaining 10 weeks were titrated to up to 10 mg per day donepezil based on tolerability.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo for donepezil hydrochloride capsule
Intervention Type
Drug
Intervention Name(s)
Donepezil
Other Intervention Name(s)
Aricept
Intervention Description
5 mg donepezil hydrochloride capsule.
Intervention Type
Drug
Intervention Name(s)
Donepezil
Other Intervention Name(s)
Aricept
Intervention Description
10 mg donepezil hydrochloride capsule.
Primary Outcome Measure Information:
Title
One-card Learning (OCL) Measurement Over 12 Weeks of Treatment
Description
OCL is one of the Cogstate battery of tests, and is a continuous visual recognition task that assesses visual recognition, memory and attention using a pattern separation algorithm. OCL is a score defined as the arcsine transformation of the square root of the proportion of correct responses to 80 OCL questions. The score ranges from 0 to 1.5708 where a higher score means better performance.
Time Frame
Weeks 4, 8, 12 and 16
Secondary Outcome Measure Information:
Title
Percentage of Correct Responses in the OCL Task Over 12 Weeks of Treatment
Description
OCL is one of the Cogstate battery of tests, and is a continuous visual recognition task that assesses visual recognition, memory and attention using a pattern separation algorithm. The percentage of correct responses to 80 OCL questions is defined as the number of correct responses x 100 divided by the number of total responses; and ranges from 0 to 100, where 100 is best, and 0 is the worst outcome.
Time Frame
Weeks 4, 8, 12 and 16
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
IPD Sharing URL
http://engagezone.msd.com/ds_documentation.php
Learn more about this trial
Computerized Cognition Testing in Participants With Mild Alzheimer's Disease (AD) Treated With Donepezil (MK-0000-318)
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