Cognitive AbilitiesNCT02367898
Enhancing Cognitive Abilities With Comprehensive Training
A study testing Lumosity Cognitive Training and Crossword Puzzles in people with Cognitive Abilities, run by Lumos Labs, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to measure the efficacy of an online cognitive training program against an active control condition in a large, randomized trial. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Abilities
- What is being tested?
- Lumosity Cognitive Training and Crossword Puzzles
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11,470 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to Apr 2014
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Engaged with the Lumosity program at least 3 days in the first week after sign-up
- Access to an internet enabled computer to complete training
Who cannot join
- Paying subscriber
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Enhancing Cognitive Abilities With Comprehensive Training: A Large, Online, Randomized, Active-Controlled Trial
The purpose of this study is to measure the efficacy of an online cognitive training program against an active control condition in a large, randomized trial.
Read the detailed description
The present study aims to evaluate a targeted, progressively challenging, online cognitive training program comprised of 49 distinct exercises targeting a variety of cognitive capacities. The cognitive training program will be compared to a plausibly beneficial active control condition in which participants completed online crossword puzzles.
The investigators hypothesize that the cognitive training will show greater transfer to a range of underlying cognitive abilities than the active control, as measured by a broad battery of neuropsychological assessments and participant-reported outcomes.
- Conditions
- Cognitive Abilities
- Being tested
- Lumosity Cognitive Training, Crossword Puzzles
- Keywords
- Cognitive Training, Lumosity, Crossword Puzzles
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumosity Cognitive TrainingOther
adaptive online cognitive training
Crossword PuzzlesOther
timed online crossword puzzles
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Training | Experimental | Lumosity cognitive training program. Receives: Other: Lumosity Cognitive Training |
| Crossword Puzzles | Active comparator | Timed online crossword puzzles Receives: Other: Crossword Puzzles |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aggregate Cognitive Performance
Aggregate cognitive performance, as measured by Grand Index, on seven neuropsychological assessments (Forward Memory Span, Reverse Memory Span, Grammatical Reasoning, Progressive Matrices, Go/No-Go, Arithmetic Reasoning, Two-Target Search)
Measured: Baseline to 10 weeks
Secondary outcomes (2)
Participant-Reported Outcomes
9 questions related to everyday cognition and emotional status.
Measured: Baseline to 10 weeks
Individual Neuropsychological Assessments composite
Separate analyses of changes on each of the seven neuropsychological assessments in the battery (Forward Memory Span, Reverse Memory Span, Grammatical Reasoning, Progressive Matrices, Go/No-Go, Arithmetic Reasoning, Two-Target Search).
Measured: Baseline to 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2015 (estimated)
- Study startApr 2013
- Primary completionApr 2014
- Study completionApr 2014
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 Cognitive AbilitiesStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 11,470 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lumos Labs, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Wheaton College, Wayne State University
- Responsible party
- Sponsor
- Investigators
- Daniel Sternberg, PhD, Principal investigator, Lumos Labs, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02367898
- Sponsor's protocol ID
- LLI-001
- Status last verified
- Sep 2015
- First submitted
- 13 Feb 2015
- Last updated
- 11 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Hardy JL, Nelson RA, Thomason ME, Sternberg DA, Katovich K, Farzin F, Scanlon M. Enhancing Cognitive Abilities with Comprehensive Training: A Large, Online, Randomized, Active-Controlled Trial. PLoS One. 2015 Sep 2;10(9):e0134467. doi: 10.1371/journal.pone.0134467. eCollection 2015.
PubMed 26333022
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Cognitive Abilities With Comprehensive Training: A Large, Online, Randomized, Active-Controlled Trial
- ClinicalTrials.gov ID
- NCT02367898
- Acronym / sponsor ID
- LLI-001
- Conditions
- Cognitive Abilities
- Keywords
- Cognitive Training, Lumosity, Crossword Puzzles
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11,470 participants (actual)
- Lead sponsor
- Lumos Labs, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Wheaton College, Wayne State University
- Study start
- Apr 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 20 Feb 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 purpose of this study is to measure the efficacy of an online cognitive training program against an active control condition in a large, randomized trial.
Detailed description
The present study aims to evaluate a targeted, progressively challenging, online cognitive training program comprised of 49 distinct exercises targeting a variety of cognitive capacities. The cognitive training program will be compared to a plausibly beneficial active control condition in which participants completed online crossword puzzles.
The investigators hypothesize that the cognitive training will show greater transfer to a range of underlying cognitive abilities than the active control, as measured by a broad battery of neuropsychological assessments and participant-reported outcomes.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive Training | Experimental | Other: Lumosity Cognitive TrainingLumosity cognitive training program. |
| Crossword Puzzles | Active comparator | Other: Crossword PuzzlesTimed online crossword puzzles |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Engaged with the Lumosity program at least 3 days in the first week after sign-up
- Access to an internet enabled computer to complete training
Key exclusion criteria (1 listed)
- Paying subscriber
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 |
|---|---|---|
| Lumosity Cognitive Trainingadaptive online cognitive training | Other | Cognitive Training |
| Crossword Puzzlestimed online crossword puzzles | Other | Crossword Puzzles |
Primary outcome
Aggregate Cognitive Performance
Time frame: Baseline to 10 weeks
Aggregate cognitive performance, as measured by Grand Index, on seven neuropsychological assessments (Forward Memory Span, Reverse Memory Span, Grammatical Reasoning, Progressive Matrices, Go/No-Go, Arithmetic Reasoning, Two-Target Search)
2 secondary outcomes
Participant-Reported Outcomes
Time frame: Baseline to 10 weeks
Individual Neuropsychological Assessments composite
Time frame: Baseline to 10 weeks
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 11 Sep 2015.
- Derived from this study: PubMed 26333022Hardy JL, Nelson RA, Thomason ME, Sternberg DA, Katovich K, Farzin F, Scanlon M. Enhancing Cognitive Abilities with Comprehensive Training: A Large, Online, Randomized, Active-Controlled Trial. PLoS One. 2015 Sep 2;10(9):e0134467. doi: 10.1371/journal.pone.0134467. eCollection 2015.
- Click here for more information about Lumosity's Human Cognition Project.Link 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.
Daniel Sternberg, PhD principal investigator
Lumos Labs, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lumosity Cognitive Training and Crossword Puzzles in people with Cognitive Abilities, run by Lumos Labs, Inc. 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 1 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 11 Sep 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?
Aggregate Cognitive Performance (time frame: Baseline to 10 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 NCT02367898, 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 11 Sep 2015.