HealthyPhase 1/2NCT00526942
Behavioral and Physiological Effects of Visual Training
A Phase 1/2 study testing SAAGE-designed, visual memory-based cognitive training in people with Healthy, run by Posit Science Corporation at 1 site in United States.
Trial summary
The primary objective of this study is to evaluate the learnability of a 3 week, 40 minutes per day, 5 day per week, computer-based visual training exercise by healthy mature individuals undergoing normal aging. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- SAAGE-designed, visual memory-based cognitive training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2007to Aug 2008
- Phase
- Phase 1/2
- 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
- Age 60 or older at the time of consent.
- Mini-Mental Status Examination (MMSE) score of 26 or higher.
- Adequate visual capacity adequate to read.
- Adequate hearing capacity.
- Willing and able to commit to study time requirements.
Who cannot join
- Self-report of current diagnosis or history of major neurological illness.
- Self-report of current diagnosis or history of psychiatric illness. c. History of psychiatric hospitalization in the past twenty years.
- 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. - Fibromyalgia or symptoms of severe tremor.
- Self-report of current substance abuse, including alcoholism.
- Current useof medications with substantial CNS effects. Inappropriate behaviors during screening or baseline visits.
- Inability to perform behavioral evaluations.
- Participant is not capable of giving informed consent or 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, 1 recruiting
- Recruiting
Posit Science Corporation
San Francisco Bay Area, California, 94104
Daniel Tinker, BS, 415-394-3100 ext. 3541, daniel.tinker@positscience.com
Cate Stasio, BA, 4153943100 ext. 3546, cate.stasio@positscience.com
About this study
Official title: Computer-Based Cognitive Training in Normal Healthy Aging: Pilot Study of Behavioral and Physiological Effects of Visual Sweeps Training Exercise, 2-Arm Model
The primary objective of this study is to evaluate the learnability of a 3 week, 40 minutes per day, 5 day per week, computer-based visual training exercise by healthy mature individuals undergoing normal aging.
Read the detailed description
Virtually all adults will suffer a decline in their cognitive capacities to some degree. Typically, cognitive decline is characterized by a slow, progressive decline in abilities (frequently in memory, attention, inhibition and speed of processing) relative to younger adults, commonly called normal aging, age-associated memory impairment, age-consistent memory impairment, benign senescent forgetfulness, late-life forgetfulness, ageing-associated cognitive decline, and the preferred term, age-related cognitive decline (ARCD) As virtually all adults experience a reduction in their cognitive abilities with age, ARCD has generally been considered to be a normal, inevitable, and irreversible part of aging; and the extremely severe forms of pathological cognitive decline (e.g., Alzheimer's disease, AD) have dominated therapeutic research in this area. However, ARCD represents an important cause of quality of life decline in almost every older adult, as the impact of forgetfulness and mental slowing increasingly change the abilities of individuals to successfully manage their day-to-day activities. Therapeutic approaches targeting the specific problems of ARCD in normal aging (as opposed to the pathological problems of AD) would unto themselves represent important clinical advances.
This trial investigates the effects of a computer-based visual training exercise built on the principles of positive brain plasticity and designed for use by healthy mature individuals. The program is specifically designed to improve the fidelity of sensory representations in early visual cortex.
- Conditions
- Healthy
- Being tested
- SAAGE-designed, visual memory-based cognitive training
- Keywords
- ACRD, Visual Memory, Visual Perception, Speed, Computerized, SAAGE, Cognitive Decline
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAAGE-designed, visual memory-based cognitive trainingBehavioural
Also called Hawkeye
Training sessions take 40 minutes per day, five days per week for a total goal of 15, 40-minute sessions.
| Study group | Role | What they receive |
|---|---|---|
| I | No intervention | No contact control (NCC) |
| II | Experimental | Computerized, SAAGE-designed, visual memory-based cognitive training Receives: Behavioral: SAAGE-designed, visual memory-based cognitive training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in visual memory assessment after training or no-contact period.
Measured: 6-8 weeks
Secondary outcomes (3)
Improvement on at least 1 of the Computerized Visual Attention, Speed and Memory Tests conducted.
Measured: 6-8 weeks
Improvement on the computerized cognitive assessments.
Measured: 6-8 weeks
Improvement on exercise-based assessments.
Measured: 6-8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2007 (estimated)
- Study startAug 2007
- Study completionAug 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Posit Science Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of San Francisco
- Investigators
- Joseph L Hardy, PhD, Principal investigator, Posit Science Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00526942
- Sponsor's protocol ID
- RES-203-2007
- Status last verified
- Sep 2007
- First submitted
- 6 Sep 2007
- Last updated
- 11 Sep 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
Bischkopf J, Busse A, Angermeyer MC. Mild cognitive impairment--a review of prevalence, incidence and outcome according to current approaches. Acta Psychiatr Scand. 2002 Dec;106(6):403-14. doi: 10.1034/j.1600-0447.2002.01417.x.
PubMed 12392483Fillit HM, Butler RN, O'Connell AW, Albert MS, Birren JE, Cotman CW, Greenough WT, Gold PE, Kramer AF, Kuller LH, Perls TT, Sahagan BG, Tully T. Achieving and maintaining cognitive vitality with aging. Mayo Clin Proc. 2002 Jul;77(7):681-96. doi: 10.4065/77.7.681.
PubMed 12108606Ahissar E, Nagarajan S, Ahissar M, Protopapas A, Mahncke H, Merzenich MM. Speech comprehension is correlated with temporal response patterns recorded from auditory cortex. Proc Natl Acad Sci U S A. 2001 Nov 6;98(23):13367-72. doi: 10.1073/pnas.201400998.
PubMed 11698688Park HL, O'Connell JE, Thomson RG. A systematic review of cognitive decline in the general elderly population. Int J Geriatr Psychiatry. 2003 Dec;18(12):1121-34. doi: 10.1002/gps.1023.
PubMed 14677145Scarmeas N, Stern Y. Cognitive reserve: implications for diagnosis and prevention of Alzheimer's disease. Curr Neurol Neurosci Rep. 2004 Sep;4(5):374-80. doi: 10.1007/s11910-004-0084-7.
PubMed 15324603
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computer-Based Cognitive Training in Normal Healthy Aging: Pilot Study of Behavioral and Physiological Effects of Visual Sweeps Training Exercise, 2-Arm Model
- ClinicalTrials.gov ID
- NCT00526942
- Acronym / sponsor ID
- RES-203-2007
- Conditions
- Healthy
- Keywords
- ACRD, Visual Memory, Visual Perception, Speed, Computerized, SAAGE, Cognitive Decline
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Posit Science CorporationIndustry (pharma, biotech, devices)
- Collaborators
- University of San Francisco
- Study start
- Aug 2007
- Study completion
- Aug 2008 (estimated)
- First posted
- 10 Sep 2007 (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 learnability of a 3 week, 40 minutes per day, 5 day per week, computer-based visual training exercise by healthy mature individuals undergoing normal aging.
Detailed description
Virtually all adults will suffer a decline in their cognitive capacities to some degree. Typically, cognitive decline is characterized by a slow, progressive decline in abilities (frequently in memory, attention, inhibition and speed of processing) relative to younger adults, commonly called normal aging, age-associated memory impairment, age-consistent memory impairment, benign senescent forgetfulness, late-life forgetfulness, ageing-associated cognitive decline, and the preferred term, age-related cognitive decline (ARCD) As virtually all adults experience a reduction in their cognitive abilities with age, ARCD has generally been considered to be a normal, inevitable, and irreversible part of aging; and the extremely severe forms of pathological cognitive decline (e.g., Alzheimer's disease, AD) have dominated therapeutic research in this area. However, ARCD represents an important cause of quality of life decline in almost every older adult, as the impact of forgetfulness and mental slowing increasingly change the abilities of individuals to successfully manage their day-to-day activities. Therapeutic approaches targeting the specific problems of ARCD in normal aging (as opposed to the pathological problems of AD) would unto themselves represent important clinical advances.
This trial investigates the effects of a computer-based visual training exercise built on the principles of positive brain plasticity and designed for use by healthy mature individuals. The program is specifically designed to improve the fidelity of sensory representations in early visual cortex.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| I | No intervention | –No contact control (NCC) |
| II | Experimental | Behavioral: SAAGE-designed, visual memory-based cognitive trainingComputerized, SAAGE-designed, visual memory-based cognitive training |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 60 or older at the time of consent.
- Mini-Mental Status Examination (MMSE) score of 26 or higher.
- Adequate visual capacity adequate to read.
- Adequate hearing capacity.
- Willing and able to commit to study time requirements.
Key exclusion criteria (8 listed)
- Self-report of current diagnosis or history of major neurological illness.
- Self-report of current diagnosis or history of psychiatric illness. c. History of psychiatric hospitalization in the past twenty years.
- 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. - Fibromyalgia or symptoms of severe tremor.
- Self-report of current substance abuse, including alcoholism.
- Current useof medications with substantial CNS effects. Inappropriate behaviors during screening or baseline visits.
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 |
|---|---|---|
| SAAGE-designed, visual memory-based cognitive trainingAlso: HawkeyeTraining sessions take 40 minutes per day, five days per week for a total goal of 15, 40-minute sessions. | Behavioural | II |
Primary outcome
Improvement in visual memory assessment after training or no-contact period.
Time frame: 6-8 weeks
3 secondary outcomes
Improvement on at least 1 of the Computerized Visual Attention, Speed and Memory Tests conducted.
Time frame: 6-8 weeks
Improvement on the computerized cognitive assessments.
Time frame: 6-8 weeks
Improvement on exercise-based assessments.
Time frame: 6-8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2007.
- Background: PubMed 12392483Bischkopf J, Busse A, Angermeyer MC. Mild cognitive impairment--a review of prevalence, incidence and outcome according to current approaches. Acta Psychiatr Scand. 2002 Dec;106(6):403-14. doi: 10.1034/j.1600-0447.2002.01417.x.
- Background: PubMed 12108606Fillit HM, Butler RN, O'Connell AW, Albert MS, Birren JE, Cotman CW, Greenough WT, Gold PE, Kramer AF, Kuller LH, Perls TT, Sahagan BG, Tully T. Achieving and maintaining cognitive vitality with aging. Mayo Clin Proc. 2002 Jul;77(7):681-96. doi: 10.4065/77.7.681.
- Background: PubMed 11698688Ahissar E, Nagarajan S, Ahissar M, Protopapas A, Mahncke H, Merzenich MM. Speech comprehension is correlated with temporal response patterns recorded from auditory cortex. Proc Natl Acad Sci U S A. 2001 Nov 6;98(23):13367-72. doi: 10.1073/pnas.201400998.
- Background: PubMed 14677145Park HL, O'Connell JE, Thomson RG. A systematic review of cognitive decline in the general elderly population. Int J Geriatr Psychiatry. 2003 Dec;18(12):1121-34. doi: 10.1002/gps.1023.
- Background: PubMed 15324603Scarmeas N, Stern Y. Cognitive reserve: implications for diagnosis and prevention of Alzheimer's disease. Curr Neurol Neurosci Rep. 2004 Sep;4(5):374-80. doi: 10.1007/s11910-004-0084-7.
- Click here for more information about computerized cognitive trainingLink provided by the sponsor.
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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.
Joseph L Hardy, 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 Phase 1/2 study testing SAAGE-designed, visual memory-based cognitive training in people with Healthy, 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 5 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 11 Sep 2007. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Daniel Tinker, BS (4153943100 ext. 3541, daniel.tinker@positscience.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in visual memory assessment after training or no-contact period. (time frame: 6-8 weeks). 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 NCT00526942, which also lists 5 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 11 Sep 2007.