- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02628548
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
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
Interventional
Enrollment (Actual)
175
Phase
- 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
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Massachusetts
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Boston, Massachusetts, United States, 02129
- Massachusetts General Hospital
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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
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:
- 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.
- 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
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 |
Intervention / Treatment |
|---|---|
|
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.
|
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.
|
8 week cognitive training program
|
What is the study measuring?
Primary Outcome Measures
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.
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8 weeks
|
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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.
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8 weeks
|
Secondary Outcome Measures
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.
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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.
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2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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.
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)
January 18, 2016
Primary Completion (Actual)
December 31, 2021
Study Completion (Actual)
December 31, 2021
Study Registration Dates
First Submitted
November 30, 2015
First Submitted That Met QC Criteria
December 8, 2015
First Posted (Estimate)
December 11, 2015
Study Record Updates
Last Update Posted (Actual)
September 7, 2022
Last Update Submitted That Met QC Criteria
September 2, 2022
Last Verified
September 1, 2022
More Information
Terms related to this study
Other Study ID 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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