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

NCT02064920 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 0000-318
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

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

Conditions

Alzheimer's Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Percentage of Correct Responses in the OCL Task Over 12 Weeks of Treatment

  Weeks 4, 8, 12 and 16

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo for donepezil hydrochloride capsule administered orally once a day for 16 weeks.

Drug: Placebo

Donepezil

EXPERIMENTAL

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; Drug: Donepezil

Interventions

Placebo DRUG

Placebo for donepezil hydrochloride capsule

Donepezil; Placebo

Donepezil DRUG

5 mg donepezil hydrochloride capsule.

Also known as: Aricept

Donepezil

Eligibility Criteria

• Age: 55 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Donepezil

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Indans; Indenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2014
• First Posted: February 17, 2014
• Study Start: April 22, 2014
• Primary Completion: July 13, 2016
• Study Completion: July 13, 2016
• Last Updated: October 12, 2018
• Results First Posted: August 1, 2017

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will share