Computer-Based Therapy for Mild Cognitive Impairment

This study has been completed.

Sponsor:

Collaborators:

University of California, San Francisco

University of California, Davis

Stanford University

Information provided by:

Posit Science Corporation

ClinicalTrials.gov Identifier:

NCT00319943

First received: April 27, 2006

Last updated: NA

Last verified: April 2006

History: No changes posted

Tracking Information

First Received Date ^ICMJE

April 27, 2006

Last Updated Date

April 27, 2006

Start Date ^ICMJE

September 2004

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

The study investigates changes in a neuropsychological assessment battery pre-randomization
and upon the completion of training.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Early evaluations will be conducted from brain imaging; specifically, date
obtained via positron emission tomography (PET), magnetoencephalography (MEG),
electroencephalography (EEG), and functional magnetic resonance imaging (fMRI)
studies.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Computer-Based Therapy for Mild Cognitive Impairment

Official Title ^ICMJE

Computer-Based Therapy for Mild Cognitive Impairment

Brief Summary

The purpose of this study is to determine the neuropsychological and neurophysiological impacts of a computer-based training program designed to improve the cognitive performance of patients with mild cognitive impairment (MCI).

Detailed Description

The study is a randomized, double-blind, controlled trial of a computerized, cognitive intervention with three main goals: 1) to assess the magnitude of improvements in memory, language function, and cognitive function following computer training, 2) to investigate the neurophysiological mechanisms underlying such neuropsychological improvements, and 3) to demonstrate the feasibility of using this kind of computer-based therapy in older populations.

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Condition ^ICMJE

Mild Cognitive Impairment

Intervention ^ICMJE

Procedure: Computer-based training for Mild Cognitive Impairment (MCI)

Study Arm (s)

Not Provided

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

July 2006

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

Inclusion Criteria:

1)65 - 90 years of age 2)Meet definition for MCI including complaints of cognitive decline as indicated by patient report and/or informant report, and corroborated by clinician judgment and, the absence of dementia, defined as impairment of memory and at least one other domain of cognitive function.

3)Fluency in English 4)Willing to meet the time commitment of the study

Exclusion Criteria:

Clinically significant cerebrovascular disease
Individuals scheduled to begin acetylcholinesterase inhibitor (AChEI) therapy -

Gender

Both

Ages

65 Years to 90 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00319943

Other Study ID Numbers ^ICMJE

OUT-108-2005

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Posit Science Corporation

Collaborators ^ICMJE

University of California, San Francisco
University of California, Davis
Stanford University

Investigators ^ICMJE

Principal Investigator:

Joel Kramer, PsyD

University of California, San Francisco

Information Provided By

Posit Science Corporation

Verification Date

April 2006

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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