- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00319943
Computer-Based Therapy for Mild Cognitive Impairment
April 27, 2006 updated by: Posit Science Corporation
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment
48
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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San Francisco, California, United States, 94143
- University of California, San Francisco
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years to 90 years (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
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Exclusion Criteria:
- Clinically significant cerebrovascular disease
- Individuals scheduled to begin acetylcholinesterase inhibitor (AChEI) therapy -
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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The study investigates changes in a neuropsychological assessment battery pre-randomization
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and upon the completion of training.
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Secondary Outcome Measures
Outcome Measure |
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Early evaluations will be conducted from brain imaging; specifically, date
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obtained via positron emission tomography (PET), magnetoencephalography (MEG),
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electroencephalography (EEG), and functional magnetic resonance imaging (fMRI)
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studies.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Joel Kramer, PsyD, University of California, San Francisco
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2004
Study Completion
July 1, 2006
Study Registration Dates
First Submitted
April 27, 2006
First Submitted That Met QC Criteria
April 27, 2006
First Posted (Estimate)
April 27, 2006
Study Record Updates
Last Update Posted (Estimate)
April 27, 2006
Last Update Submitted That Met QC Criteria
April 27, 2006
Last Verified
April 1, 2006
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- OUT-108-2005
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Mild Cognitive Impairment
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Saglik Bilimleri UniversitesiAnkara UniversityRecruitingAmnestic Mild Cognitive Impairment | Amnestic Mild Cognitive DisorderTurkey
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Masaryk UniversityRecruitingMild Cognitive Impairment (MCI) Amnestic | Lewy Body Disease With Mild Cognitive Impairment | Parkinson's Disease With Mild Cognitive ImpairmentCzechia
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High Point UniversityWake Forest University Health Sciences; Hebrew SeniorLifeRecruitingMild Cognitive Impairment (MCI)United States
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Azienda Ospedaliera SS. Antonio e Biagio e Cesare...Dr. Schär AG / SPARecruitingMild Cognitive Impairment (MCI)Italy
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Xuanwu Hospital, BeijingWuhan University; Beijing Friendship Hospital; First Affiliated Hospital Xi'an... and other collaboratorsRecruitingAmnestic Mild Cognitive ImpairmentChina
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Immunotec Inc.RecruitingMild Cognitive Impairment (MCI)Canada
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Çankırı Karatekin UniversityCompletedMild Cognitive Impairment (MCI)Turkey (Türkiye)
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University of AlbertaCompleted
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Friedhelm HummelThe Novartis Foundation; Wyss Center for Bio and Neuroengineering; Clinique Romande... and other collaboratorsCompletedMild Cognitive Impairment (MCI)Switzerland
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Jennifer BramenNational Institutes of Health (NIH); National Institute on Aging (NIA)TerminatedAmnestic Mild Cognitive ImpairmentUnited States
Clinical Trials on Computer-based training for Mild Cognitive Impairment (MCI)
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University of FloridaRecruitingMild Cognitive Impairment (MCI) | Mild Cognitive Impairment | MCIUnited States
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Rosalind Franklin University of Medicine and ScienceRecruiting
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University of SalamancaNot yet recruitingCognitive Impairment | Aging ProblemsSpain
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The University of Hong KongCompletedInsomnia | Mild Cognitive ImpairmentHong Kong
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Washington University School of MedicineNational Institutes of Health (NIH)Completed
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Posit Science CorporationCompletedBreast Cancer | Memory Disorders | Cognitive SymptomsUnited States
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Bispebjerg HospitalCompletedParkinson Disease | Executive DysfunctionDenmark
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Posit Science CorporationUniversity of California, San Francisco; Case Western Reserve UniversityWithdrawn
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Posit Science CorporationUniversity of California, San FranciscoCompleted
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Centre for Addiction and Mental HealthCompleted