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Computer-Based Therapy for Mild Cognitive Impairment

Primary Purpose

Mild Cognitive Impairment

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Computer-based training for Mild Cognitive Impairment (MCI)

About this trial

This is an interventional treatment trial for Mild Cognitive Impairment focused on measuring Cognitive remediation, Cognitive impairment, computer, training

Eligibility Criteria

65 Years - 90 Years (Older Adult)All SexesDoes not accept healthy volunteers

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 -

Sites / Locations

University of California, San Francisco

Outcomes

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.

Full Information

NCT ID

NCT00319943

First Posted

April 27, 2006

Last Updated

April 27, 2006

Sponsor

Posit Science Corporation

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT00319943

Brief Title

Computer-Based Therapy for Mild Cognitive Impairment

Official Title

Computer-Based Therapy for Mild Cognitive Impairment

Study Type

Interventional

2. Study Status

Record Verification Date

April 2006

Overall Recruitment Status

Completed

Study Start Date

September 2004 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

July 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Posit Science Corporation

Collaborators

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

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Mild Cognitive Impairment

Keywords

Cognitive remediation, Cognitive impairment, computer, training

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

48 (false)

8. Arms, Groups, and Interventions

Intervention Type

Procedure

Intervention Name(s)

Computer-based training for Mild Cognitive Impairment (MCI)

Primary Outcome Measure Information:

Title

The study investigates changes in a neuropsychological assessment battery pre-randomization

Title

and upon the completion of training.

Secondary Outcome Measure Information:

Title

Early evaluations will be conducted from brain imaging; specifically, date

Title

obtained via positron emission tomography (PET), magnetoencephalography (MEG),

Title

electroencephalography (EEG), and functional magnetic resonance imaging (fMRI)

Title

studies.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

65 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Joel Kramer, PsyD

Organizational Affiliation

University of California, San Francisco

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of California, San Francisco

City

San Francisco

State/Province

California

ZIP/Postal Code

94143

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

2013810

Citation

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.

Results Reference

background

PubMed Identifier

19812460

Citation

Barnes DE, Yaffe K, Belfor N, Jagust WJ, DeCarli C, Reed BR, Kramer JH. Computer-based cognitive training for mild cognitive impairment: results from a pilot randomized, controlled trial. Alzheimer Dis Assoc Disord. 2009 Jul-Sep;23(3):205-10. doi: 10.1097/WAD.0b013e31819c6137.

Results Reference

derived

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Computer-Based Therapy for Mild Cognitive Impairment

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