NCT00319943

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Sep 2004

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

April 27, 2006

Completed
Same day until next milestone

First Posted

Study publicly available on registry

April 27, 2006

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2006

Completed
Last Updated

April 27, 2006

Status Verified

April 1, 2006

First QC Date

April 27, 2006

Last Update Submit

April 27, 2006

Conditions

Mild Cognitive Impairment

Keywords

Cognitive remediationCognitive impairmentcomputertraining

Outcome Measures

Primary Outcomes (2)

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

  • and upon the completion of training.

Secondary Outcomes (4)

  • 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.

Interventions

Computer-based training for Mild Cognitive Impairment (MCI)PROCEDURE

Eligibility Criteria

Age65 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

Related Publications (2)

  • 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.

    PMID: 2013810BACKGROUND

  • 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.

    PMID: 19812460DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Joel Kramer, PsyD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 27, 2006

First Posted

April 27, 2006

Study Start

September 1, 2004

Study Completion

July 1, 2006

Last Updated

April 27, 2006

Record last verified: 2006-04

Locations

US(1)