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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
  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 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Computer-Based Therapy for Mild Cognitive Impairment

Resource links provided by NLM:

U.S. FDA Resources

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:

  1. Clinically significant cerebrovascular disease
  2. 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:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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

Keywords provided by Posit Science Corporation:
Cognitive remediation
Cognitive impairment
computer
training

Additional relevant MeSH terms:
Cognition Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 16, 2013