AgingNCT02628548
Neural Correlates of Successful Cognitive Aging
A study testing Cognitive training program in people with Aging, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
Normal aging is associated with gradual cognitive declines. These mild neurocognitive disturbances affect daily functioning, health status, and quality of life, and likely account for the roughly $2.9 billion lost by the elderly each year to fraud. Read more about this study
- Who is it for?
- Ages 65 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- Cognitive training program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 175 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jan 2016to 31 Dec 2021
- 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 85 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 65-80 years of age
- Right-handed
Who cannot join
- Lifetime history of schizophrenia or psychosis. Any other Axis I diagnosis in the past 12 months.
- Subjects must not endorse suicidality, homicidality or self-destructive acts or urges as assessed through a structured clinical interview (SCID)
- History of seizure or significant head trauma (i.e., extended loss of consciousness, neurological sequelae, or known structural brain lesion).
- Neurological or medical conditions that would interfere with study procedures or confound results, such as conditions that alter cerebral blood flow or metabolism.
- Use of psychotropic medications within 12 months prior to study.
- Daily use of any medication that alters neural metabolism or blood flow.
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- Any concurrent psychotherapy.
- Having taken no more than 8 meditation classes (or related practices such as yoga, Tai Chi, or Chi Gong) of any kind in the past 6 months, or more than 15 classes in the past 12 months.
- Pregnancy.
- Metallic implants or devices contraindicating magnetic resonance imaging.
- Claustrophobia
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02129
About this study
Official title: Neural and Cognitive Changes Associated With Mental Training in Older Adults
Normal aging is associated with gradual cognitive declines. These mild neurocognitive disturbances affect daily functioning, health status, and quality of life, and likely account for the roughly $2.9 billion lost by the elderly each year to fraud. The goal of this project is to compare two different 8-week training programs to promote successful neural and cognitive aging. Changes in neural structure and cognitive function will be assessed in a cohort of older adults, as well as the long-term stability of these changes over 24 months.
Read the detailed description
Normal aging is associated with gradual cognitive declines. These mild neurocognitive disturbances affect daily functioning, health status, and quality of life, and likely account for the roughly $2.9 billion lost by the elderly each year to fraud. People are paying millions out of pocket for cognitive training programs like Lumosity to stave off these declines. These cognitive decreases have been strongly associated with normal age-dependent declines in neural structure and function, including cortical thickness decreases (approximately 0.02 mm per decade) across most of the cortical mantle, as well as decreases in the volume of the hippocampus (approximately 1-2% annually), white matter microstructure, and functional connectivity across the brain. Life expectancy is increasing and so identifying interventions that can be widely implemented and that can slow or reverse normal cognitive decline are clinical and public health priorities. Some training programs can improve cognitive performance in cognitively normal older adults, and gains are maintained post training. The investigators hypothesize that different techniques to boost cognition likely works through different neural mechanisms, and thus may provide different cognitive benefits. The goal of this project is to compare two different 8-week training programs to promote successful neural and cognitive aging. Changes in neural structure and cognitive function will be assessed in a cohort of older adults, as well as the long-term stability of these changes over 24 months.
- Conditions
- Aging
- Being tested
- Cognitive training program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive training programBehavioural
8 week cognitive training program
| Study group | Role | What they receive |
|---|---|---|
| Cognitive training program 1 | Experimental | This 8-week program will meet once per week for 1.5 hours. Participants will be trained in performing various cognition enhancing techniques at each class, and will practice these techniques both in class and at home each day for 45 minutes. Receives: Behavioral: Cognitive training program |
| Cognitive training program 2 | Experimental | This 8-week program will meet once per week for 1.5 hours. Participants will be trained in performing various cognition enhancing techniques at each class, and will practice these techniques both in class and at home each day for 45 minutes. Receives: Behavioral: Cognitive training program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in brain structure
Gray matter structure will be assessed before and after the 8 week programs.
Measured: 8 weeks
Change in brain activity during a memory test
Brain activity during a memory task will be assessed before and after the 8 week programs.
Measured: 8 weeks
Secondary outcomes (2)
Blood markers
Blood will be collected at baseline, 8 weeks, 12 and 24 months. This will be used to assess changes in various biomarkers that are known to change with aging.
Measured: baseline, 8 weeks, 12 and 24 months
Change in cognition
Participants will complete a series of memory and attention tests at 6 time-points: baseline, 2 months, 6 months, 12 months 18 months and 24 months.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2015 (estimated)
- Study start18 Jan 2016
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AgingStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 175 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Sara W Lazar, Massachusetts General Hospital
- Investigators
- Sara Lazar, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02628548
- Sponsor's protocol ID
- 2015P001851
- Other IDs
- R01AG048351
- Status last verified
- Sep 2022
- First submitted
- 30 Nov 2015
- Last updated
- 7 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Madl T, Lazar S. Integrated Decentering: Validating an Automated Measure of Decentering Expression Across Seven Independent Samples. Res Sq [Preprint]. 2026 Aug 14:rs.3.rs-10410851. doi: 10.21203/rs.3.rs-10410851/v1.
PubMed 42845576Sevinc G, Rusche J, Wong B, Datta T, Kaufman R, Gutz SE, Schneider M, Todorova N, Gaser C, Thomalla G, Rentz D, Dickerson BD, Lazar SW. Mindfulness Training Improves Cognition and Strengthens Intrinsic Connectivity Between the Hippocampus and Posteromedial Cortex in Healthy Older Adults. Front Aging Neurosci. 2021 Aug 27;13:702796. doi: 10.3389/fnagi.2021.702796. eCollection 2021.
PubMed 34512305
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neural and Cognitive Changes Associated With Mental Training in Older Adults
- ClinicalTrials.gov ID
- NCT02628548
- Acronym / sponsor ID
- 2015P001851
- Conditions
- Aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 175 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Aging (NIA)
- Study start
- 18 Jan 2016 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 11 Dec 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.
Normal aging is associated with gradual cognitive declines. These mild neurocognitive disturbances affect daily functioning, health status, and quality of life, and likely account for the roughly $2.9 billion lost by the elderly each year to fraud. The goal of this project is to compare two different 8-week training programs to promote successful neural and cognitive aging. Changes in neural structure and cognitive function will be assessed in a cohort of older adults, as well as the long-term stability of these changes over 24 months.
Detailed description
Normal aging is associated with gradual cognitive declines. These mild neurocognitive disturbances affect daily functioning, health status, and quality of life, and likely account for the roughly $2.9 billion lost by the elderly each year to fraud. People are paying millions out of pocket for cognitive training programs like Lumosity to stave off these declines. These cognitive decreases have been strongly associated with normal age-dependent declines in neural structure and function, including cortical thickness decreases (approximately 0.02 mm per decade) across most of the cortical mantle, as well as decreases in the volume of the hippocampus (approximately 1-2% annually), white matter microstructure, and functional connectivity across the brain. Life expectancy is increasing and so identifying interventions that can be widely implemented and that can slow or reverse normal cognitive decline are clinical and public health priorities. Some training programs can improve cognitive performance in cognitively normal older adults, and gains are maintained post training. The investigators hypothesize that different techniques to boost cognition likely works through different neural mechanisms, and thus may provide different cognitive benefits. The goal of this project is to compare two different 8-week training programs to promote successful neural and cognitive aging. Changes in neural structure and cognitive function will be assessed in a cohort of older adults, as well as the long-term stability of these changes over 24 months.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive training program 1 | Experimental | Behavioral: Cognitive training programThis 8-week program will meet once per week for 1.5 hours. Participants will be trained in performing various cognition enhancing techniques at each class, and will practice these techniques both in class and at home each day for 45 minutes. |
| Cognitive training program 2 | Experimental | Behavioral: Cognitive training programThis 8-week program will meet once per week for 1.5 hours. Participants will be trained in performing various cognition enhancing techniques at each class, and will practice these techniques both in class and at home each day for 45 minutes. |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- 65-80 years of age
- Right-handed
Key exclusion criteria (11 listed)
- Lifetime history of schizophrenia or psychosis. Any other Axis I diagnosis in the past 12 months.
- Subjects must not endorse suicidality, homicidality or self-destructive acts or urges as assessed through a structured clinical interview (SCID)
- History of seizure or significant head trauma (i.e., extended loss of consciousness, neurological sequelae, or known structural brain lesion).
- Neurological or medical conditions that would interfere with study procedures or confound results, such as conditions that alter cerebral blood flow or metabolism.
- Use of psychotropic medications within 12 months prior to study.
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 |
|---|---|---|
| Cognitive training program8 week cognitive training program | Behavioural | Cognitive training program 1, Cognitive training program 2 |
Primary outcome
Change in brain structure
Time frame: 8 weeks
Gray matter structure will be assessed before and after the 8 week programs.
Change in brain activity during a memory test
Time frame: 8 weeks
Brain activity during a memory task will be assessed before and after the 8 week programs.
2 secondary outcomes
Blood markers
Time frame: baseline, 8 weeks, 12 and 24 months
Change in cognition
Time frame: 2 years
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 7 Sep 2022.
- Derived from this study: PubMed 42845576Madl T, Lazar S. Integrated Decentering: Validating an Automated Measure of Decentering Expression Across Seven Independent Samples. Res Sq [Preprint]. 2026 Aug 14:rs.3.rs-10410851. doi: 10.21203/rs.3.rs-10410851/v1.
- Derived from this study: PubMed 34512305Sevinc G, Rusche J, Wong B, Datta T, Kaufman R, Gutz SE, Schneider M, Todorova N, Gaser C, Thomalla G, Rentz D, Dickerson BD, Lazar SW. Mindfulness Training Improves Cognition and Strengthens Intrinsic Connectivity Between the Hippocampus and Posteromedial Cortex in Healthy Older Adults. Front Aging Neurosci. 2021 Aug 27;13:702796. doi: 10.3389/fnagi.2021.702796. eCollection 2021.
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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.
Sara Lazar, PhD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive training program in people with Aging, run by Massachusetts General Hospital 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 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 7 Sep 2022. 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?
Change in brain structure (time frame: 8 weeks). The study lists 2 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 NCT02628548, which also lists 2 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 7 Sep 2022.