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

Alzheimer's Disease Clinical Trial

Official title:

A Clinical Trial to Assess Cognitive Function by Repeated Computerized Testing in Patients With Mild Alzheimer's Disease Treated With Donepezil

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02064920
• Other study ID #: 0000-318
• Status: Completed
• Phase: Phase 2
• Start date: April 22, 2014
• Est. completion date: July 13, 2016

Study information

• Verified date: September 2018
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: July 13, 2016
• Est. primary completion date: July 13, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• Placebo
Placebo for donepezil hydrochloride capsule
• Donepezil
5 mg donepezil hydrochloride capsule.
• Donepezil
10 mg donepezil hydrochloride capsule.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Weeks 4, 8, 12 and 16
Secondary	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.	Weeks 4, 8, 12 and 16