A Study to Test the Performance of the CogState Computerized Neuropsychological Battery in Patients With Alzheimer's Disease (0000-086)(COMPLETED)

Alzheimer's Disease Clinical Trial

Official title:

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Trial, With Placebo Run-In, and an Open-Label Treatment Period, to Evaluate the Performance of the CogState Computerized Neuropsychological Battery and the ADAS-Cog in Generally Cholinesterase-naive AD Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00777608
• Other study ID #: 0000-086
• Secondary ID: 2008_573
• Status: Completed
• Phase: Phase 1
• First received: October 21, 2008
• Last updated: August 11, 2015
• Start date: December 2008
• Est. completion date: April 2010

Study information

• Verified date: August 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hungary: National Institute of Pharmacy
• Study type: Interventional

Clinical Trial Summary

This study will evaluate the performance of the CogState computerized neuropsychological battery, Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog) and Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) in participants with mild-to-moderate Alzheimer's disease (AD).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: April 2010
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years and older

Eligibility

Inclusion Criteria:

• Participant is ambulatory, male or female and 55 years of age or older

• Participant has reliable informant/caregiver who can communicate effectively with the study site and personnel

Exclusion Criteria:

• Participant has a history within the last 6 months or current evidence of a psychotic disorder or an active major depressive disorder or participant has any history of schizophrenia

• Participant has a history of multiple and/or serious allergies to drugs or food or a history of an allergic reaction to more than 3 drug classes

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• Comparator: Placebo 5mg (run in)
Matching placebo to donepezil - 5 mg capsules orally for 14 day run in prior to randomization.
• Donepezil 5 - 10 mg
Donepezil 1 capsule (5 mg) orally, once daily for 14 days. Donepezil 2 capsules (total 10 mg) once daily for 70 days (days 15-84).
• Comparator: Placebo 5-10 mg
Matching placebo to donepezil, 1 capsule (5 mg) orally, once daily for 14 days. Matching placebo to donepezil 2 capsules (total 10 mg) once daily for 70 days (days 15-84).
• Donepezil 10 mg
Donepezil 2 capsules (total 10 mg) orally, once daily for 24 weeks, from day 85 (optional).

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	Change in Mean Computer-based Cognitive Assessment (CogState) Composite Score at Week 4	CogState is a simple, brief computerized neuropsychological battery to evaluate cognitive impairments characterizing mild-to-moderate Alzheimer's Disease (AD). The composite CogState assesses attention and memory functions - including Verbal episodic memory, Visual Episodic Memory, Psychomotor function, Visual attention and working memory. CogState scores are measured on a linear scale (with no maximum score) and a reduction in scores compared to baseline indicates an improvement in cognitive functions. Reported here is the change in the CogState Composite Score at Week 4 compared to baseline.	Baseline and 4 weeks	No
Secondary	Evaluate the Efficacy of Donepezil by Determining the Change in Mean CogState Composite Score at Week 2, Week 8 and Week 12	CogState is a simple, brief computerized neuropsychological battery to evaluate cognitive impairments characterizing mild-to-moderate Alzheimer's Disease (AD). The composite CogState assesses attention and memory functions - including Verbal episodic memory, Visual Episodic Memory, Psychomotor function, Visual attention and working memory. CogState scores are measured on a linear scale (no maximum score) and a reduction in scores compared to baseline indicates an improvement in cognitive functions. Reported here is the change from baseline in the CogState Composite Score at Weeks 4, 8 and 12.	Baseline and 2 weeks, 8 weeks and 12 weeks	No
Secondary	Evaluate the Efficacy of Donepezil by Determining the Change in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) Score at Week 4, Week 8 and Week 12	The ADAS-Cog is a psychometric instrument that evaluates memory, attention,; reasoning, language, orientation and praxis using an 11-point AD Assessment Scale. It has a minimum score of 0 and a maximum severity score of 70, and a higher score indicates more impairment. A reduction in scores compared to baseline indicates an improvement in cognitive functions. Reported here is the change in the ADAS-Cog score at Weeks 4, 8 and 12 compared to baseline.	Baseline and 4 weeks, 8 weeks and 12 weeks.	No