Mild Cognitive ImpairmentPhase 1NCT00319943
Computer-Based Therapy for Mild Cognitive Impairment
A Phase 1 study testing Computer-based training for Mild Cognitive Impairment (MCI) in people with Mild Cognitive Impairment, run by Posit Science Corporation at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 65 to 90 years
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- Computer-based training for Mild Cognitive Impairment (MCI)
- Type of treatment
- Surgery or procedure
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2004to Jul 2006
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 90 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
- -
Who cannot join
- Clinically significant cerebrovascular disease
- Individuals scheduled to begin acetylcholinesterase inhibitor (AChEI) therapy -
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
San Francisco, California, 94143
About this study
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).
Read the 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.
- Conditions
- Mild Cognitive Impairment
- Being tested
- Computer-based training for Mild Cognitive Impairment (MCI)
- Keywords
- Cognitive remediation, Cognitive impairment, computer, training
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computer-based training for Mild Cognitive Impairment (MCI)Procedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2006 (estimated)
- Study startSep 2004
- Study completionJul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 48 participants
Sponsor and investigators
- Lead sponsor
- Posit Science Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of California, San Francisco, University of California, Davis, Stanford University
- Investigators
- Joel Kramer, PsyD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00319943
- Sponsor's protocol ID
- OUT-108-2005
- Status last verified
- Apr 2006
- First submitted
- 27 Apr 2006
- Last updated
- 27 Apr 2006
- Results posted
- No
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.
PubMed 2013810Barnes 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.
PubMed 19812460
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computer-Based Therapy for Mild Cognitive Impairment
- ClinicalTrials.gov ID
- NCT00319943
- Acronym / sponsor ID
- OUT-108-2005
- Conditions
- Mild Cognitive Impairment
- Keywords
- Cognitive remediation, Cognitive impairment, computer, training
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants
- Lead sponsor
- Posit Science CorporationIndustry (pharma, biotech, devices)
- Collaborators
- University of California, San Francisco, University of California, Davis, Stanford University
- Study start
- Sep 2004
- Study completion
- Jul 2006
- First posted
- 27 Apr 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 65 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 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
- -
Key exclusion criteria (2 listed)
- Clinically significant cerebrovascular disease
- Individuals scheduled to begin acetylcholinesterase inhibitor (AChEI) therapy -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computer-based training for Mild Cognitive Impairment (MCI) | Procedure or surgery | – |
Primary outcome
The study investigates changes in a neuropsychological assessment battery pre-randomization
and upon the completion of training.
4 secondary outcomes
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2006.
- Background: PubMed 2013810Mejia 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.
- Derived from this study: PubMed 19812460Barnes 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joel Kramer, PsyD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Computer-based training for Mild Cognitive Impairment (MCI) in people with Mild Cognitive Impairment, run by Posit Science Corporation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The study investigates changes in a neuropsychological assessment battery pre-randomization. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00319943, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2006; AzTrials last refreshed its copy on 29 Oct 2026.