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Trial record 31 of 331 for:    DONEPEZIL

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
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Drug: Placebo Drug: Donepezil Phase 2

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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.
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.
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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
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

Information from the National Library of Medicine

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


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
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Study Director: Medical Director Merck Sharp & Dohme Corp.

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Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT02064920     History of Changes
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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Donepezil
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents