Computerized Cognition Testing in Participants With Mild Alzheimer's Disease (AD) Treated With Donepezil (MK-0000-318)

September 14, 2018 updated by: Merck Sharp & Dohme LLC

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 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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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 Names:
  • Aricept
Drug: Donepezil
10 mg donepezil hydrochloride capsule.
Other Names:
  • Aricept

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Weeks 4, 8, 12 and 16

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Weeks 4, 8, 12 and 16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 22, 2014

Primary Completion (Actual)

July 13, 2016

Study Completion (Actual)

July 13, 2016

Study Registration Dates

First Submitted

February 14, 2014

First Submitted That Met QC Criteria

February 14, 2014

First Posted (Estimate)

February 17, 2014

Study Record Updates

Last Update Posted (Actual)

October 12, 2018

Last Update Submitted That Met QC Criteria

September 14, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0000-318

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Alzheimer's Disease

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in South Africa

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe