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

ClinicalTrials.gov Identifier:

NCT00777608

First received: October 21, 2008

Last updated: March 24, 2011

Last verified: March 2011

History of Changes

Results First Received: January 27, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment
Condition:	Alzheimer's Disease
Interventions:	Drug: Comparator: Placebo 5mg (run in) Drug: Donepezil 5 - 10 mg Drug: Comparator: Placebo 5-10 mg Drug: Donepezil 10 mg

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Donepezil 5-10 mg	Participants were randomized to donepezil for 84 days
Placebo	Participants were randomized to placebo for 84 days

Participant Flow: Overall Study

	Donepezil 5-10 mg	Placebo
STARTED	53	53
COMPLETED	49	47
NOT COMPLETED	4	6
Lost to Follow-up	1	1
Withdrawal by Subject	1	3
Protocol Violation	1	0
Investigator Decision	1	2

Baseline Characteristics

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Reporting Groups

	Description
Donepezil 5-10 mg	Participants were randomized to donepezil for 84 days
Placebo	Participants were randomized to placebo for 84 days
Total	Total of all reporting groups

Baseline Measures

	Donepezil 5-10 mg	Placebo	Total
Number of Participants [units: participants]	53	53	106
Age, Customized ^[1] [units: Participants]	53	53	106
Gender [units: participants]
Female	23	22	45
Male	30	31	61

[1]	Age >= 55 years

Outcome Measures

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1. Primary:

Change in Mean Computer-based Cognitive Assessment (CogState) Composite Score at Week 4 [ Time Frame: Baseline and 4 weeks ]

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2. Secondary:

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 ]

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3. 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 [ Time Frame: Baseline and 4 weeks, 8 weeks and 12 weeks. ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Vice President of Late Stage Development
Organization: Merck Sharp and Dohme Corp
e-mail: ClinicalTrialsDisclosure@merck.com

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:	MK-0000-086, 2008_573
Study First Received:	October 21, 2008
Results First Received:	January 27, 2011
Last Updated:	March 24, 2011
Health Authority:	Hungary: National Institute of Pharmacy

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