AgingNCT00337909
Computer-Based Training for Cognitive Enhancement: Classroom Study
A study testing Computerized Plasticity-Based Adaptive Cognitive Training and Educational DVDs in people with Aging, run by Posit Science Corporation at 1 site in United States.
Trial summary
The primary objective of this study is to evaluate the design and effectiveness of a computer-based training program on the memory and cognitive abilities of mature individuals undergoing healthy aging. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- Computerized Plasticity-Based Adaptive Cognitive Training and Educational DVDs
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2005to Mar 2006
- Phase
- Interventional
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- A)Participants must be at least 60 years old B)Participants must have a Mini-Mental State Exam (MMSE) score of 24 or higher to ensure that participants do not meet common criteria for dementia C)Participants must be a native English speaker D)Participants must be able to see well enough to read the consent form E)Participants must be able to hear well enough to understand ordinary spoken conversation when the clinical specialist holds a paper in front of his or her face to prevent the participant from lip-reading.
- F)Participants must be willing to commit to the time requirements of the study and not have any scheduled trips or absences for more than 1 week during the training.
Who cannot join
- A)Participants must not be planning to begin cholinesterase inhibitor (AChEI) therapy or to change their dosing levels. Subjects currently using AChEI will be included if they have an established steady dosing history at least one month prior to the study and are expected to continue at the same dosage throughout the study.
- B)Participants must not have had a head trauma that caused them to lose consciousness in the past five years and have had no subsequent symptoms.
- C)Participants must not have had a stroke within the past year; or have had a stroke that has left them with expressive or receptive language problems.
- D)Participants must not have any central nervous system disorder that could contribute to cognitive impairment.
- E)Participants must not have a tremor preventing the use of a computer mouse or other pointing device.
- F)Participants must not currently be active in another clinical trial.
Trial locations and contacts
1 site in 1 country.
United States1 site
Posit Science Corporation
San Francisco, California, 94108
About this study
The primary objective of this study is to evaluate the design and effectiveness of a computer-based training program on the memory and cognitive abilities of mature individuals undergoing healthy aging.
Read the detailed description
The purpose of this study is to test the new progressions design of a computer-based training program and to demonstrate the effectiveness of this refined cognitive training regimen on participants' performance on normed neuropsychological measures.
Subjects meeting eligibility criteria and providing written, informed consent will complete 40 one hour sessions of a computer based training program.
- Conditions
- Aging
- Being tested
- Computerized Plasticity-Based Adaptive Cognitive Training, Educational DVDs
- Keywords
- cognitive enhancement, memory, auditory memory, speech, computerized
- Medical subject headings
- Speech
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computerized Plasticity-Based Adaptive Cognitive TrainingOther
Also called BrainHQ, Brain Fitness Program
Educational DVDsOther
| Study group | Role | What they receive |
|---|---|---|
| Experimental Treatment | Experimental | Computerized Plasticity-Based Adaptive Cognitive Training Receives: Other: Computerized Plasticity-Based Adaptive Cognitive Training |
| Active Control | Active comparator | Educational DVDs Receives: Other: Educational DVDs |
| No Contact Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of training program.
Secondary outcomes (1)
Evaluation of training effects.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2006 (estimated)
- Study startSep 2005
- Primary completionMar 2006
- Study completionMar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AgingStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Posit Science Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Henry W Mahncke, PhD, Principal investigator, Posit Science Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00337909
- Sponsor's protocol ID
- OUT-107-2005
- Status last verified
- Oct 2015
- First submitted
- 15 Jun 2006
- Last updated
- 2 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Mahncke HW, Bronstone A, Merzenich MM. Brain plasticity and functional losses in the aged: scientific bases for a novel intervention. Prog Brain Res. 2006;157:81-109. doi: 10.1016/S0079-6123(06)57006-2.
PubMed 17046669
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computer-Based Training for Cognitive Enhancement: Classroom Study
- ClinicalTrials.gov ID
- NCT00337909
- Acronym / sponsor ID
- OUT-107-2005
- Conditions
- Aging
- Keywords
- cognitive enhancement, memory, auditory memory, speech, computerized
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Posit Science CorporationIndustry (pharma, biotech, devices)
- Study start
- Sep 2005
- Primary completion
- Mar 2006 (actual)
- Study completion
- Mar 2006 (actual)
- First posted
- 20 Jun 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 primary objective of this study is to evaluate the design and effectiveness of a computer-based training program on the memory and cognitive abilities of mature individuals undergoing healthy aging.
Detailed description
The purpose of this study is to test the new progressions design of a computer-based training program and to demonstrate the effectiveness of this refined cognitive training regimen on participants' performance on normed neuropsychological measures.
Subjects meeting eligibility criteria and providing written, informed consent will complete 40 one hour sessions of a computer based training program.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental Treatment | Experimental | Other: Computerized Plasticity-Based Adaptive Cognitive TrainingComputerized Plasticity-Based Adaptive Cognitive Training |
| Active Control | Active comparator | Other: Educational DVDsEducational DVDs |
| No Contact Control | No intervention | – |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- A)Participants must be at least 60 years old B)Participants must have a Mini-Mental State Exam (MMSE) score of 24 or higher to ensure that participants do not meet common criteria for dementia C)Participants must be a native English speaker D)Participants must be able to see well enough to read the consent form E)Participants must be able to hear well enough to understand ordinary spoken conversation when the clinical specialist holds a paper in front of his or her face to prevent the participant from lip-reading.
- F)Participants must be willing to commit to the time requirements of the study and not have any scheduled trips or absences for more than 1 week during the training.
Key exclusion criteria (6 listed)
- A)Participants must not be planning to begin cholinesterase inhibitor (AChEI) therapy or to change their dosing levels. Subjects currently using AChEI will be included if they have an established steady dosing history at least one month prior to the study and are expected to continue at the same dosage throughout the study.
- B)Participants must not have had a head trauma that caused them to lose consciousness in the past five years and have had no subsequent symptoms.
- C)Participants must not have had a stroke within the past year; or have had a stroke that has left them with expressive or receptive language problems.
- D)Participants must not have any central nervous system disorder that could contribute to cognitive impairment.
- E)Participants must not have a tremor preventing the use of a computer mouse or other pointing device.
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 |
|---|---|---|
| Computerized Plasticity-Based Adaptive Cognitive TrainingAlso: BrainHQ, Brain Fitness Program | Other | Experimental Treatment |
| Educational DVDs | Other | Active Control |
Primary outcome
Evaluation of training program.
1 secondary outcome
Evaluation of training effects.
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 2 Nov 2015.
- Results publication: PubMed 17046669Mahncke HW, Bronstone A, Merzenich MM. Brain plasticity and functional losses in the aged: scientific bases for a novel intervention. Prog Brain Res. 2006;157:81-109. doi: 10.1016/S0079-6123(06)57006-2.
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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.
Henry W Mahncke, PhD principal investigator
Posit Science Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computerized Plasticity-Based Adaptive Cognitive Training and Educational DVDs in people with Aging, 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 2 inclusion and 6 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 2 Nov 2015. 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.
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?
Evaluation of training program.. 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 NCT00337909, which also lists 1 linked publication.
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 2 Nov 2015.