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

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00777608
First received: October 21, 2008
Last updated: October 25, 2013
Last verified: October 2013
  Purpose

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).


Condition Intervention Phase
Alzheimer's Disease
Drug: Comparator: Placebo 5mg (run in)
Drug: Donepezil 5 - 10 mg
Drug: Comparator: Placebo 5-10 mg
Drug: Donepezil 10 mg
Phase 1

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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Change in Mean Computer-based Cognitive Assessment (CogState) Composite Score at Week 4 [ Time Frame: Baseline and 4 weeks ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Evaluate the Efficacy of Donepezil by Determining the Change in Mean CogState Composite Score at Week 2, Week 8 and Week 12 [ Time Frame: Baseline and 2 weeks, 8 weeks and 12 weeks ] [ Designated as safety issue: No ]
    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.

  • 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 [ Time Frame: Baseline and 4 weeks, 8 weeks and 12 weeks. ] [ Designated as safety issue: No ]

    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.



Enrollment: 106
Study Start Date: December 2008
Study Completion Date: April 2010
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Donepezil 5-10 mg
There will be a 14 day period when all participants will receive placebo, followed by 5 mg donepezil, once daily for 14 days then titrated to 10 mg donepezil once daily for 70 days. Participants may then receive open-label donepezil for an additional 24 weeks.
Drug: Comparator: Placebo 5mg (run in)
Matching placebo to donepezil - 5 mg capsules orally for 14 day run in prior to randomization.
Drug: 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).

Drug: Donepezil 10 mg
Donepezil 2 capsules (total 10 mg) orally, once daily for 24 weeks, from day 85 (optional).
Placebo Comparator: Placebo
There will be a 14 day period when all participants will receive placebo. Participants will take placebo capsules orally, once daily for 84 days. Participants may then receive open-label donepezil for an additional 24 weeks.
Drug: Comparator: Placebo 5mg (run in)
Matching placebo to donepezil - 5 mg capsules orally for 14 day run in prior to randomization.
Drug: 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).

Drug: Donepezil 10 mg
Donepezil 2 capsules (total 10 mg) orally, once daily for 24 weeks, from day 85 (optional).

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00777608

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

No publications provided

Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00777608     History of Changes
Other Study ID Numbers: 0000-086, 2008_573
Study First Received: October 21, 2008
Results First Received: January 27, 2011
Last Updated: October 25, 2013
Health Authority: Hungary: National Institute of Pharmacy

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Donepezil
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 15, 2014