Older Adults, Aging BrainPACR-ADNCT02331784
Plasticity-based Adaptive Cognitive Remediation for Alzheimer Disease
A study testing Computerized Plasticity-based Software and Commercially available Video Game in people with Older Adults, Aging Brain, 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 the experimental treatment (cognitive training) further outlined in this protocol on the cognitive abilities (e.g., processing speed, attention, working memory, and executive function), brain functionality, functional status and quality of life of… Read more about this study
- Who is it for?
- Ages 65 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Older Adults, Aging Brain
- What is being tested?
- Computerized Plasticity-based Software and Commercially available Video Game
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2015to 20 Apr 2017
- 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 to 79 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Age 65-79 years at the time of consent
- Fluent English speakers, to ensure reasonable results neuropsychological assessments
- Adequate sensorimotor capacity to perform the program, including visual capacity adequate to read from a computer screen at a normal viewing distance, auditory capacity adequate to understand normal speech, and motor capacity adequate to control a computer mouse
- No evidence of dementia as indicated by Montreal Cognitive Assessment (MoCA) scores >25
Who cannot join
- Diagnosis with Alzheimer's disease or related dementias
- Requiring caregiver assistance in dressing/personal hygiene
- Medical conditions predisposing to imminent functional decline
- Recent participation of computer-delivered cognitive training
- Diagnosis of an illness or condition with known cognitive consequences (e.g., schizophrenia, bipolar disorder, cancer, multiple sclerosis) will be excluded due to the confound with cognitive impairment from normal aging.
- Uncorrectable acuity greater than 20/40
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- Self-reported cardiovascular disease
- Claustrophobia or any other contraindication to MRI scanning
- Inability to complete a 1-hour MRI
- Any implanted devices above the waist (e.g., cardiac pacemaker or auto-defibrillators, neural pacemaker, aneurysm clips, cochlear implant, metallic bodies in the eye or central nervous system, any form of wires or metal devices that may concentrate radio frequency fields)
- History of brain surgery; removal of brain tissue; or history of stroke.
Trial locations and contacts
1 site in 1 country.
About this study
The primary objective of this study is to evaluate the effects of the experimental treatment (cognitive training) further outlined in this protocol on the cognitive abilities (e.g., processing speed, attention, working memory, and executive function), brain functionality, functional status and quality of life of individuals with age-related cognitive decline as compared to a computer-based active control.
Read the detailed description
The normal aging has a devastating effect on our cognitive ability to learn and remember, on the speed with which the investigators process information, and on our ability to reason. By 2050, nearly 14 million individuals in the US will be living with Alzheimer's disease (AD), up from 5 million in 2013. AD is the most common cause of dementia, resulting in the loss of cognitive functions such as memory, reasoning, language, and cognitive, social, physical, and emotional control, to the extent that losses interfere with activities of daily living and necessitate continuous monitoring and care. Many studies now show that the processing machinery of the brain is plastic and remodeled throughout life by learning and experience, enabling the strengthening of cognitive skills or abilities. Research has shown that brief, daily computerized cognitive training that is sufficiently challenging, goal-directed and adaptive enables intact brain structures to restore balance in attention and compensate for disruptions in cognitive functioning. The study aims to understand how our computer program can affect cognition and attention in those with aging brain.
- Conditions
- Older Adults, Aging Brain
- Being tested
- Computerized Plasticity-based Software, Commercially available Video Game
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computerized Plasticity-based SoftwareBehavioural
Participants will be asked to use their assigned training program for forty minutes per session, up to five sessions per week, over 10 weeks (50 total sessions).
Commercially available Video GameBehavioural
Participants will be asked to use their assigned video games for forty minutes per session, up to five sessions per week, over 10 weeks (50 total sessions).
| Study group | Role | What they receive |
|---|---|---|
| Computerized Plasticity-based Software | Experimental | Computerized Plasticity-based software training requiring a total maximum of 50 treatment sessions, 4-5 times weekly, 40 minutes each session. Receives: Behavioral: Computerized Plasticity-based Software |
| Commercially available video game | Active comparator | Commercially available video game training. Treatment is software based, will occur up to 50 times throughout study duration, 4-5 times per week, 40 minutes each session.. Receives: Behavioral: Commercially available Video Game |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in performance on global cognitive composite score
Change in performance on global cognitive composite score based on the average of all normalized assessment measures.
Measured: Baseline and at the completion of 10 weeks of training
Secondary outcomes (6)
Changes in brain function
Change in resting state functional connectivity will be measured by resting State T2*weighted EPI-BOLD, a 10-minute task-free BOLD contrast sequence consisting of 300 volumes (TR=2000 ms/TE=30ms) at 3.4mm3 in-plane resolution and 3mm slice thickness. Participants will be instructed to keep their eyes open and maintain attention on a central gray fixation cross on a black screen.
Measured: Baseline and at the completion of 10 weeks of training
Changes in brain structure
3D T1-Weighted multi-echo MPRAGE. Morphometric analyses will be based on this MRI sequence (not accelerated because the reliability of acceleration for multi-site studies has not yet been established). We will achieve spatial resolution of 1 x 1 x 1 mm voxels.
Measured: Baseline and at the completion of 10 weeks of training
Changes in task-related brain activation
Change in functional connectivity and brain activation will be measured while performing Flanker Task.
Measured: Baseline and at the completion of 10 weeks of training
Changes in performance on memory composite score
Change in performance on memory will be measured using the composite score created by averaging the z-scores of Visual Short Term Memory, Spatial Working Memory and N-Back tasks.
Measured: Baseline and at the completion of 10 weeks of training
Changes in performance on executive function composite score
Change in performance on executive function will be measured using the composite score created by averaging the z-scores for the Flanker, Stroop and Trail Making tasks.
Measured: Baseline and at the completion of 10 weeks of training
Changes in performance on processing speed composite score
Change in performance on processing speed will be measured using the composite score created by averaging the z-scores of Pattern Comparison, Letter Comparison, and Digit Symbol Coding tasks.
Measured: Baseline and at the completion of 10 weeks of training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2015 (estimated)
- Study startApr 2015
- Primary completion20 Apr 2017
- Study completion20 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Older Adults, Aging BrainStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Posit Science Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Iowa
- Responsible party
- Sponsor
- Investigators
- Hyunkyu Lee, Ph.D., Principal investigator, Posit Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02331784
- Sponsor's protocol ID
- PSC-PACR-AD-01
- Acronym
- PACR-AD
- Status last verified
- Apr 2019
- First submitted
- 18 Dec 2014
- Last updated
- 19 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plasticity-based Adaptive Cognitive Remediation for Alzheimer Disease
- ClinicalTrials.gov ID
- NCT02331784
- Acronym / sponsor ID
- PACR-AD / PSC-PACR-AD-01
- Conditions
- Older Adults, Aging Brain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Posit Science CorporationIndustry (pharma, biotech, devices)
- Collaborators
- University of Iowa
- Study start
- Apr 2015
- Primary completion
- 20 Apr 2017 (actual)
- Study completion
- 20 Apr 2017 (actual)
- First posted
- 6 Jan 2015 (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 the experimental treatment (cognitive training) further outlined in this protocol on the cognitive abilities (e.g., processing speed, attention, working memory, and executive function), brain functionality, functional status and quality of life of individuals with age-related cognitive decline as compared to a computer-based active control.
Detailed description
The normal aging has a devastating effect on our cognitive ability to learn and remember, on the speed with which the investigators process information, and on our ability to reason. By 2050, nearly 14 million individuals in the US will be living with Alzheimer's disease (AD), up from 5 million in 2013. AD is the most common cause of dementia, resulting in the loss of cognitive functions such as memory, reasoning, language, and cognitive, social, physical, and emotional control, to the extent that losses interfere with activities of daily living and necessitate continuous monitoring and care. Many studies now show that the processing machinery of the brain is plastic and remodeled throughout life by learning and experience, enabling the strengthening of cognitive skills or abilities. Research has shown that brief, daily computerized cognitive training that is sufficiently challenging, goal-directed and adaptive enables intact brain structures to restore balance in attention and compensate for disruptions in cognitive functioning. The study aims to understand how our computer program can affect cognition and attention in those with aging brain.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Computerized Plasticity-based Software | Experimental | Behavioral: Computerized Plasticity-based SoftwareComputerized Plasticity-based software training requiring a total maximum of 50 treatment sessions, 4-5 times weekly, 40 minutes each session. |
| Commercially available video game | Active comparator | Behavioral: Commercially available Video GameCommercially available video game training. Treatment is software based, will occur up to 50 times throughout study duration, 4-5 times per week, 40 minutes each session.. |
Who may qualify
- Ages
- 65 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Age 65-79 years at the time of consent
- Fluent English speakers, to ensure reasonable results neuropsychological assessments
- Adequate sensorimotor capacity to perform the program, including visual capacity adequate to read from a computer screen at a normal viewing distance, auditory capacity adequate to understand normal speech, and motor capacity adequate to control a computer mouse
- No evidence of dementia as indicated by Montreal Cognitive Assessment (MoCA) scores >25
Key exclusion criteria (11 listed)
- Diagnosis with Alzheimer's disease or related dementias
- Requiring caregiver assistance in dressing/personal hygiene
- Medical conditions predisposing to imminent functional decline
- Recent participation of computer-delivered cognitive training
- Diagnosis of an illness or condition with known cognitive consequences (e.g., schizophrenia, bipolar disorder, cancer, multiple sclerosis) will be excluded due to the confound with cognitive impairment from normal aging.
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 SoftwareParticipants will be asked to use their assigned training program for forty minutes per session, up to five sessions per week, over 10 weeks (50 total sessions). | Behavioural | Computerized Plasticity-based Software |
| Commercially available Video GameParticipants will be asked to use their assigned video games for forty minutes per session, up to five sessions per week, over 10 weeks (50 total sessions). | Behavioural | Commercially available video game |
Primary outcome
Changes in performance on global cognitive composite score
Time frame: Baseline and at the completion of 10 weeks of training
Change in performance on global cognitive composite score based on the average of all normalized assessment measures.
6 secondary outcomes
Changes in brain function
Time frame: Baseline and at the completion of 10 weeks of training
Changes in brain structure
Time frame: Baseline and at the completion of 10 weeks of training
Changes in task-related brain activation
Time frame: Baseline and at the completion of 10 weeks of training
Changes in performance on memory composite score
Time frame: Baseline and at the completion of 10 weeks of training
Changes in performance on executive function composite score
Time frame: Baseline and at the completion of 10 weeks of training
Changes in performance on processing speed composite score
Time frame: Baseline and at the completion of 10 weeks of training
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 19 Apr 2019.
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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.
Hyunkyu Lee, Ph.D. principal investigator
Posit Science
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 Software and Commercially available Video Game in people with Older Adults, Aging Brain, 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 4 inclusion and 11 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 19 Apr 2019. 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?
Changes in performance on global cognitive composite score (time frame: Baseline and at the completion of 10 weeks of training). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Apr 2019.