Neural Correlates of Successful Cognitive Aging

September 2, 2022 updated by: Sara W Lazar, Massachusetts General Hospital

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
175

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02129
        • Massachusetts General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

65 years to 85 years (Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 65-80 years of age
  • Right-handed

Exclusion Criteria:

  1. Lifetime history of schizophrenia or psychosis. Any other Axis I diagnosis in the past 12 months.
  2. Subjects must not endorse suicidality, homicidality or self-destructive acts or urges as assessed through a structured clinical interview (SCID)
  3. History of seizure or significant head trauma (i.e., extended loss of consciousness, neurological sequelae, or known structural brain lesion).
  4. Neurological or medical conditions that would interfere with study procedures or confound results, such as conditions that alter cerebral blood flow or metabolism.
  5. Use of psychotropic medications within 12 months prior to study.
  6. Daily use of any medication that alters neural metabolism or blood flow.
  7. Any concurrent psychotherapy.
  8. 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.
  9. Pregnancy.
  10. Metallic implants or devices contraindicating magnetic resonance imaging.
  11. Claustrophobia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Cognitive training program 1
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.
Behavioral: Cognitive training program
8 week cognitive training program
Experimental: Cognitive training program 2
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.
Behavioral: Cognitive training program
8 week cognitive training program

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in brain structure
Time Frame: 8 weeks
Gray matter structure will be assessed before and after the 8 week programs.
8 weeks
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.
8 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Blood markers
Time Frame: baseline, 8 weeks, 12 and 24 months
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.
baseline, 8 weeks, 12 and 24 months
Change in cognition
Time Frame: 2 years
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.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Massachusetts General Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institutes of Health (NIH)
National Institute on Aging (NIA)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 18, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 30, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 8, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 11, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 7, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 2, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2015P001851
  • R01AG048351 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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