Computer-Based Therapy for Mild Cognitive Impairment - Full Text View

Purpose

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).

Condition	Intervention	Phase
Mild Cognitive Impairment	Procedure: Computer-based training for Mild Cognitive Impairment (MCI)	Phase I

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	Computer-Based Therapy for Mild Cognitive Impairment

Further study details as provided by Posit Science Corporation:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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.

Estimated Enrollment:	48
Study Start Date:	September 2004
Estimated Study Completion Date:	July 2006

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.

Eligibility

Ages Eligible for Study:	65 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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 -

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00319943

Locations


United States, California
	University of California, San Francisco
	San Francisco, California, United States, 94143

Sponsors and Collaborators

Posit Science Corporation

University of California, San Francisco

University of California, Davis

Stanford University

Investigators


Principal Investigator:	Joel Kramer, PsyD	University of California, San Francisco

More Information

Publications:

Mejia AA, Nakamura T, Masatoshi I, Hatazawa J, Masaki M, Watanuki S. Estimation of absorbed doses in humans due to intravenous administration of fluorine-18-fluorodeoxyglucose in PET studies. J Nucl Med. 1991 Apr;32(4):699-706.

Study ID Numbers:	OUT-108-2005
First Received:	April 27, 2006
Last Updated:	April 27, 2006
ClinicalTrials.gov Identifier:	NCT00319943
Health Authority:	United States: Food and Drug Administration

Keywords provided by Posit Science Corporation:

Cognitive remediation

Cognitive impairment

computer

training

ClinicalTrials.gov processed this record on October 06, 2008

Sponsors and Collaborators:	Posit Science Corporation University of California, San Francisco University of California, Davis Stanford University
Information provided by:	Posit Science Corporation
ClinicalTrials.gov Identifier:	NCT00319943