Computerized Cognition Testing in Participants With Mild Alzheimer's Disease (AD) Treated With Donepezil (MK-0000-318)
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ClinicalTrials.gov Identifier: NCT02064920 |
Recruitment Status :
Completed
First Posted : February 17, 2014
Results First Posted : August 1, 2017
Last Update Posted : October 12, 2018
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Condition or disease | Intervention/treatment | Phase |
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Alzheimer's Disease | Drug: Placebo Drug: Donepezil | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 36 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Diagnostic |
Official Title: | A Clinical Trial to Assess Cognitive Function by Repeated Computerized Testing in Patients With Mild Alzheimer's Disease Treated With Donepezil |
Actual Study Start Date : | April 22, 2014 |
Actual Primary Completion Date : | July 13, 2016 |
Actual Study Completion Date : | July 13, 2016 |

Arm | Intervention/treatment |
---|---|
Placebo Comparator: Placebo
Placebo for donepezil hydrochloride capsule administered orally once a day for 16 weeks.
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Drug: Placebo
Placebo for donepezil hydrochloride capsule |
Experimental: Donepezil
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.
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Drug: Placebo
Placebo for donepezil hydrochloride capsule Drug: Donepezil 5 mg donepezil hydrochloride capsule.
Other Name: Aricept Drug: Donepezil 10 mg donepezil hydrochloride capsule.
Other Name: Aricept |
- One-card Learning (OCL) Measurement Over 12 Weeks of Treatment [ Time Frame: Weeks 4, 8, 12 and 16 ]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.
- Percentage of Correct Responses in the OCL Task Over 12 Weeks of Treatment [ Time Frame: Weeks 4, 8, 12 and 16 ]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.

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Ages Eligible for Study: | 55 Years to 85 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02064920
Study Director: | Medical Director | Merck Sharp & Dohme LLC |
Responsible Party: | Merck Sharp & Dohme LLC |
ClinicalTrials.gov Identifier: | NCT02064920 |
Other Study ID Numbers: |
0000-318 |
First Posted: | February 17, 2014 Key Record Dates |
Results First Posted: | August 1, 2017 |
Last Update Posted: | October 12, 2018 |
Last Verified: | September 2018 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf |
URL: | http://engagezone.msd.com/ds_documentation.php |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases Tauopathies Neurodegenerative Diseases Neurocognitive Disorders Mental Disorders |
Donepezil Cholinesterase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Cholinergic Agents Neurotransmitter Agents Physiological Effects of Drugs Nootropic Agents |