AgingIMPACTNCT00283010
Improvement in Memory With Plasticity-Based Adaptive Cognitive Training (IMPACT)
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 effects 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 65 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
- 487 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2006to Apr 2008
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Age 65 or older at the time of consent.
- Mini-Mental State Examination (MMSE) score of 26 or higher.
- Fluent English speaker. For the purposes of this study, fluency will be defined as living in an English speaking country and attending an English speaking school by the age of six (participants will demonstrate fluency by reading aloud a selected paragraph).
- Visual capacity adequate to read 14 point type (participants will demonstrate visual capacity by reading aloud a selected sentence).
- Adequate hearing capacity. (Participants will demonstrate by repeating a series of words spoken by the screening clinician; the words will be spoken while a view of the clinician's mouth is obstructed to prevent lip-reading.)
- Willing and able to commit to the 6-month time requirement of the entire study period with an emphasis on availability for the 8-10 week computer based training.
Who cannot join
- Mini-Mental State Examination (MMSE) score of 25 or lower.
- Self-report of current diagnosis or history of major neurological illness. Specifically:
- Alzheimer's disease
- Parkinson's disease
- Multiple sclerosis
- Amyotrophic lateral sclerosis
Show all 21Show fewer
- Self-report of current diagnosis or history of psychiatric illness. Specifically:
- Major depressive disorder
- Bipolar disorder
- Schizophrenia
- Post traumatic stress disorder
- Obsessive-compulsive disorder
- Self-reported history of psychiatric hospitalization.
- History of a stroke, transient ischemic attack (TIA), or traumatic brain injury within the past year; or lifetime history of stroke, TIA, or traumatic brain injury that has left residual expressive or receptive language problems. Traumatic brain injuries include, but are not limited to: concussion with loss of consciousness; head trauma with loss of consciousness; persistent migraines (persistent being defined as a predictable pattern occurring more frequently than every other month); and history of seizure disorder.
- Fibromyalgia or symptoms of tremor severe enough to prevent the use of a computer mouse or other pointing device. Clinician to observe participant during signature of consent form, during drawing portion of Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) assessment, and to directly ask participant as instructed in the Body Image Ideals Questionnaire (BIQ) to make tremor assessment.
- Self-report of current substance abuse, including alcoholism.
- Current use, or use within the past 3 months, of medications with substantial central nervous system (CNS) effects, including acetylcholinesterase inhibitors and medications with either anticholinergic or antidepressant properties.
- Behaviors during screening or baseline visits that, in the judgment of the screening clinician, are likely to present significant problems for the trainers in the in home setting may be excluded at the discretion of the clinician. Such behaviors include significant uncooperative behavior, significant rudeness or temper management problems, or inappropriate physical conduct.
- Unable to perform neuropsychological evaluations.
- Participant is not capable of giving informed consent or is unable to comprehend and/or follow instructions.
- Participant is enrolled in a concurrent clinical study that could affect the outcome of this study.
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 effects of a computer-based training program on the memory and cognitive abilities of mature individuals undergoing healthy aging.
Read the detailed description
The computer-based training program is focused on speech reception to strengthen an individual's memory for speech. This type of training program was chosen because speech perception and memory are crucial elements of human communication and losses in this area are often the first signal of overall cognitive decline.
Subjects meeting eligibility criteria and providing written, informed consent are randomized to one of two 40-session, computerized training programs.
- Conditions
- Aging
- Being tested
- Computerized Plasticity-Based Adaptive Cognitive Training, Educational DVDs
- Keywords
- cognitive enhancement, memory, auditory memory, speech, computerized, cognitive decline
- Medical subject headings
- Speech, Cognitive Dysfunction
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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive effects of training
Measured: 6 months
Secondary outcomes (1)
Safety effects of computer-based training
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2006 (estimated)
- Study startJan 2006
- Primary completionApr 2008
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- 487 participants (actual)
Sponsor and investigators
- Lead sponsor
- Posit Science Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Mayo Clinic, University of Southern California
- Responsible party
- Sponsor
- Investigators
- Henry W Mahncke, PhD, Principal investigator, Posit Science Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00283010
- Sponsor's protocol ID
- OUT-105-2005
- Acronym
- IMPACT
- Status last verified
- Oct 2015
- First submitted
- 25 Jan 2006
- Last updated
- 2 Nov 2015
- Results posted
- No
Publications
Smith GE, Housen P, Yaffe K, Ruff R, Kennison RF, Mahncke HW, Zelinski EM. A cognitive training program based on principles of brain plasticity: results from the Improvement in Memory with Plasticity-based Adaptive Cognitive Training (IMPACT) study. J Am Geriatr Soc. 2009 Apr;57(4):594-603. doi: 10.1111/j.1532-5415.2008.02167.x. Epub 2009 Feb 9.
PubMed 19220558Zelinski EM, Spina LM, Yaffe K, Ruff R, Kennison RF, Mahncke HW, Smith GE. Improvement in memory with plasticity-based adaptive cognitive training: results of the 3-month follow-up. J Am Geriatr Soc. 2011 Feb;59(2):258-65. doi: 10.1111/j.1532-5415.2010.03277.x.
PubMed 21314646Zelinski EM, Peters KD, Hindin S, Petway KT 2nd, Kennison RF. Evaluating the relationship between change in performance on training tasks and on untrained outcomes. Front Hum Neurosci. 2014 Aug 13;8:617. doi: 10.3389/fnhum.2014.00617. eCollection 2014.
PubMed 25165440
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
- Improvement in Memory With Plasticity-Based Adaptive Cognitive Training (IMPACT)
- ClinicalTrials.gov ID
- NCT00283010
- Acronym / sponsor ID
- IMPACT / OUT-105-2005
- Conditions
- Aging
- Keywords
- cognitive enhancement, memory, auditory memory, speech, computerized, cognitive decline
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 487 participants (actual)
- Lead sponsor
- Posit Science CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Mayo Clinic, University of Southern California
- Study start
- Jan 2006
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 27 Jan 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 effects of a computer-based training program on the memory and cognitive abilities of mature individuals undergoing healthy aging.
Detailed description
The computer-based training program is focused on speech reception to strengthen an individual's memory for speech. This type of training program was chosen because speech perception and memory are crucial elements of human communication and losses in this area are often the first signal of overall cognitive decline.
Subjects meeting eligibility criteria and providing written, informed consent are randomized to one of two 40-session, computerized training programs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| 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 |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- Age 65 or older at the time of consent.
- Mini-Mental State Examination (MMSE) score of 26 or higher.
- Fluent English speaker. For the purposes of this study, fluency will be defined as living in an English speaking country and attending an English speaking school by the age of six (participants will demonstrate fluency by reading aloud a selected paragraph).
- Visual capacity adequate to read 14 point type (participants will demonstrate visual capacity by reading aloud a selected sentence).
- Adequate hearing capacity. (Participants will demonstrate by repeating a series of words spoken by the screening clinician; the words will be spoken while a view of the clinician's mouth is obstructed to prevent lip-reading.)
Key exclusion criteria (21 listed)
- Mini-Mental State Examination (MMSE) score of 25 or lower.
- Self-report of current diagnosis or history of major neurological illness. Specifically:
- Self-report of current diagnosis or history of psychiatric illness. Specifically:
- Self-reported history of psychiatric hospitalization.
- History of a stroke, transient ischemic attack (TIA), or traumatic brain injury within the past year; or lifetime history of stroke, TIA, or traumatic brain injury that has left residual expressive or receptive language problems. Traumatic brain injuries include, but are not limited to: concussion with loss of consciousness; head trauma with loss of consciousness; persistent migraines (persistent being defined as a predictable pattern occurring more frequently than every other month); and history of seizure disorder.
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
Cognitive effects of training
Time frame: 6 months
1 secondary outcome
Safety effects of computer-based training
Time frame: 6 months
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 19220558Smith GE, Housen P, Yaffe K, Ruff R, Kennison RF, Mahncke HW, Zelinski EM. A cognitive training program based on principles of brain plasticity: results from the Improvement in Memory with Plasticity-based Adaptive Cognitive Training (IMPACT) study. J Am Geriatr Soc. 2009 Apr;57(4):594-603. doi: 10.1111/j.1532-5415.2008.02167.x. Epub 2009 Feb 9.
- Results publication: PubMed 21314646Zelinski EM, Spina LM, Yaffe K, Ruff R, Kennison RF, Mahncke HW, Smith GE. Improvement in memory with plasticity-based adaptive cognitive training: results of the 3-month follow-up. J Am Geriatr Soc. 2011 Feb;59(2):258-65. doi: 10.1111/j.1532-5415.2010.03277.x.
- Results publication: PubMed 25165440Zelinski EM, Peters KD, Hindin S, Petway KT 2nd, Kennison RF. Evaluating the relationship between change in performance on training tasks and on untrained outcomes. Front Hum Neurosci. 2014 Aug 13;8:617. doi: 10.3389/fnhum.2014.00617. eCollection 2014.
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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 6 inclusion and 21 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?
Cognitive effects of training (time frame: 6 months). 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 NCT00283010, which also lists 3 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 2 Nov 2015.