Age-related Cognitive DeclineALERTNCT02416401
Attention Training for Learning Enhancement and Resilience Trial
A study testing Computerized Plasticity-Based Adaptive Cognitive Training and Commercially available computerized training in people with Age-related Cognitive Decline, run by Posit Science Corporation at 2 sites in United States.
Trial summary
Healthy aging is associated with a decline in multiple cognitive domains, as well as motor control function. The long-term consequences of cognitive and functional impairment resulting from age-related cognitive decline are well documented in the scientific and clinical literature, with significant evidence of related… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Age-related Cognitive Decline
- What is being tested?
- Computerized Plasticity-Based Adaptive Cognitive Training and Commercially available computerized training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2015to Dec 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 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Participants must be 65 years of age or older
- Participants must have a diagnosis of age-related cognitive decline as confirmed by interview and performance on screening assessments
- Participants must be fluent English speakers
- Participants must have adequate visual, auditory, and motor capacity to use computerized intervention
Who cannot join
- Participants with diagnosis of PTSD, depression or other psychologically diagnosable emotional disorder
- Participants with a history of conditions that could affect thinking abilities, including brain injury, mental illness, cancer, or other neurological conditions (multiple sclerosis, seizure disorder), HIV/AIDS will be excluded
- Participants enrolled in another concurrent research study will be excluded
- Participants who have difficulty performing assessments or comprehending or following spoken instructions, in the judgment of the screening clinician, will be excluded
- Participants with a current or significant past history of substance abuse will be excluded
- Participants who show signs of suicidal ideations or behaviors will be excluded and referred for appropriate treatment
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Harvard Medical School
Boston, Massachusetts, 02130
University of Iowa
Iowa City, Iowa, 52242
About this study
Healthy aging is associated with a decline in multiple cognitive domains, as well as motor control function. The long-term consequences of cognitive and functional impairment resulting from age-related cognitive decline are well documented in the scientific and clinical literature, with significant evidence of related problems with independent functional abilities. This study aims to understand how the experimental computer program can affect cognition and attention in participants with age-related cognitive decline.
Read the detailed description
Following consent, participants will engage in an assessment process to determine eligibility. Once eligibility is confirmed, participants will be scheduled for another assessment session to determine current level of cognitive function. This process consists of paper-pencil surveys and computerized tests. Following the assessment process, participants will engage in an Internet browser-delivered training sessions conducted on any internet-accessible computer. The computerized training sessions can be done up to 7 times a week (once a day) or at the participant's convenience (the recommended time commitment is 5 times a week). Following the completion of training, the participant's cognitive function will be re-assessed. Participation is voluntary and participants may withdraw from the study at any time.
- Conditions
- Age-related Cognitive Decline
- Being tested
- Computerized Plasticity-Based Adaptive Cognitive Training, Commercially available computerized training
- Keywords
- healthy, aging, cognition, age-related cognitive decline
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
Commercially available computerized trainingOther
| Study group | Role | What they receive |
|---|---|---|
| Experimental Treatment | Experimental | Computerized plasticity-based adaptive cognitive training requiring a total maximum of 36 treatment sessions, 4-5 times weekly, one hour each session. Receives: Other: Computerized Plasticity-Based Adaptive Cognitive Training |
| Active Comparator | Active comparator | Commercially available computerized training requiring a total maximum of 36 treatment sessions, 4-5 times weekly, one hour each session. Receives: Other: Commercially available computerized training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Attention Measures aimed to test attention
Measures aimed to test attention
Measured: 6 months
Executive Function
Tasks targeting inhibitory control
Measured: 6 months
Functional Capacity
Performance on directly observable functional measure
Measured: 6 month
Secondary outcomes (1)
Quality of Sleep
assessing sleep quality
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 posted15 Apr 2015 (estimated)
- Study startNov 2015
- Primary completionDec 2017
- Study completionDec 2017
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 Age-related Cognitive DeclineStudies 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
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Posit Science Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Iowa, Harvard Medical School (HMS and HSDM)
- Responsible party
- Sponsor
- Investigators
- Thomas Van Vleet, PhD, Principal investigator, Posit Science Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02416401
- Sponsor's protocol ID
- PSC-1006-14
- Acronym
- ALERT
- Status last verified
- Jan 2018
- First submitted
- 7 Apr 2015
- Last updated
- 9 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Gazzaley A, Cooney JW, Rissman J, D'Esposito M. Top-down suppression deficit underlies working memory impairment in normal aging. Nat Neurosci. 2005 Oct;8(10):1298-300. doi: 10.1038/nn1543. Epub 2005 Sep 11.
PubMed 16158065Mahncke HW, Connor BB, Appelman J, Ahsanuddin ON, Hardy JL, Wood RA, Joyce NM, Boniske T, Atkins SM, Merzenich MM. Memory enhancement in healthy older adults using a brain plasticity-based training program: a randomized, controlled study. Proc Natl Acad Sci U S A. 2006 Aug 15;103(33):12523-8. doi: 10.1073/pnas.0605194103. Epub 2006 Aug 3.
PubMed 16888038Burke SN, Barnes CA. Neural plasticity in the ageing brain. Nat Rev Neurosci. 2006 Jan;7(1):30-40. doi: 10.1038/nrn1809.
PubMed 16371948Cicerone KD, Dahlberg C, Malec JF, Langenbahn DM, Felicetti T, Kneipp S, Ellmo W, Kalmar K, Giacino JT, Harley JP, Laatsch L, Morse PA, Catanese J. Evidence-based cognitive rehabilitation: updated review of the literature from 1998 through 2002. Arch Phys Med Rehabil. 2005 Aug;86(8):1681-92. doi: 10.1016/j.apmr.2005.03.024.
PubMed 16084827VanVleet T, Voss M, Dabit S, Mitko A, DeGutis J. Randomized control trial of computer-based training targeting alertness in older adults: the ALERT trial protocol. BMC Psychol. 2018 May 3;6(1):22. doi: 10.1186/s40359-018-0233-4.
PubMed 29724228
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Attention Training for Learning Enhancement and Resilience Trial
- ClinicalTrials.gov ID
- NCT02416401
- Acronym / sponsor ID
- ALERT / PSC-1006-14
- Conditions
- Age-related Cognitive Decline
- Keywords
- healthy, aging, cognition, age-related cognitive decline
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Posit Science CorporationIndustry (pharma, biotech, devices)
- Collaborators
- University of Iowa, Harvard Medical School (HMS and HSDM)
- Study start
- Nov 2015
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 15 Apr 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.
Healthy aging is associated with a decline in multiple cognitive domains, as well as motor control function. The long-term consequences of cognitive and functional impairment resulting from age-related cognitive decline are well documented in the scientific and clinical literature, with significant evidence of related problems with independent functional abilities. This study aims to understand how the experimental computer program can affect cognition and attention in participants with age-related cognitive decline.
Detailed description
Following consent, participants will engage in an assessment process to determine eligibility. Once eligibility is confirmed, participants will be scheduled for another assessment session to determine current level of cognitive function. This process consists of paper-pencil surveys and computerized tests. Following the assessment process, participants will engage in an Internet browser-delivered training sessions conducted on any internet-accessible computer. The computerized training sessions can be done up to 7 times a week (once a day) or at the participant's convenience (the recommended time commitment is 5 times a week). Following the completion of training, the participant's cognitive function will be re-assessed. Participation is voluntary and participants may withdraw from the study at any time.
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 requiring a total maximum of 36 treatment sessions, 4-5 times weekly, one hour each session. |
| Active Comparator | Active comparator | Other: Commercially available computerized trainingCommercially available computerized training requiring a total maximum of 36 treatment sessions, 4-5 times weekly, one hour each session. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Participants must be 65 years of age or older
- Participants must have a diagnosis of age-related cognitive decline as confirmed by interview and performance on screening assessments
- Participants must be fluent English speakers
- Participants must have adequate visual, auditory, and motor capacity to use computerized intervention
Key exclusion criteria (6 listed)
- Participants with diagnosis of PTSD, depression or other psychologically diagnosable emotional disorder
- Participants with a history of conditions that could affect thinking abilities, including brain injury, mental illness, cancer, or other neurological conditions (multiple sclerosis, seizure disorder), HIV/AIDS will be excluded
- Participants enrolled in another concurrent research study will be excluded
- Participants who have difficulty performing assessments or comprehending or following spoken instructions, in the judgment of the screening clinician, will be excluded
- Participants with a current or significant past history of substance abuse will be excluded
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 Training | Other | Experimental Treatment |
| Commercially available computerized training | Other | Active Comparator |
Primary outcome
Attention Measures aimed to test attention
Time frame: 6 months
Measures aimed to test attention
Executive Function
Time frame: 6 months
Tasks targeting inhibitory control
Functional Capacity
Time frame: 6 month
Performance on directly observable functional measure
1 secondary outcome
Quality of Sleep
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 9 Jan 2018.
- Background: PubMed 16158065Gazzaley A, Cooney JW, Rissman J, D'Esposito M. Top-down suppression deficit underlies working memory impairment in normal aging. Nat Neurosci. 2005 Oct;8(10):1298-300. doi: 10.1038/nn1543. Epub 2005 Sep 11.
- Background: PubMed 16888038Mahncke HW, Connor BB, Appelman J, Ahsanuddin ON, Hardy JL, Wood RA, Joyce NM, Boniske T, Atkins SM, Merzenich MM. Memory enhancement in healthy older adults using a brain plasticity-based training program: a randomized, controlled study. Proc Natl Acad Sci U S A. 2006 Aug 15;103(33):12523-8. doi: 10.1073/pnas.0605194103. Epub 2006 Aug 3.
- Background: PubMed 16371948Burke SN, Barnes CA. Neural plasticity in the ageing brain. Nat Rev Neurosci. 2006 Jan;7(1):30-40. doi: 10.1038/nrn1809.
- Background: PubMed 16084827Cicerone KD, Dahlberg C, Malec JF, Langenbahn DM, Felicetti T, Kneipp S, Ellmo W, Kalmar K, Giacino JT, Harley JP, Laatsch L, Morse PA, Catanese J. Evidence-based cognitive rehabilitation: updated review of the literature from 1998 through 2002. Arch Phys Med Rehabil. 2005 Aug;86(8):1681-92. doi: 10.1016/j.apmr.2005.03.024.
- Derived from this study: PubMed 29724228VanVleet T, Voss M, Dabit S, Mitko A, DeGutis J. Randomized control trial of computer-based training targeting alertness in older adults: the ALERT trial protocol. BMC Psychol. 2018 May 3;6(1):22. doi: 10.1186/s40359-018-0233-4.
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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.
Thomas Van Vleet, PhD principal investigator
Posit Science Corporation
2 sites 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 Commercially available computerized training in people with Age-related Cognitive Decline, run by Posit Science Corporation at 2 sites 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 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 9 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Attention Measures aimed to test attention (time frame: 6 months). The study lists 3 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 NCT02416401, 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 9 Jan 2018.