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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02628548
Other study ID # 2015P001851
Secondary ID R01AG048351
Status Completed
Phase N/A
First received
Last updated
Start date January 18, 2016
Est. completion date December 31, 2021

Study information

Verified date September 2022
Source Massachusetts General Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 175
Est. completion date December 31, 2021
Est. primary completion date December 31, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years to 85 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Cognitive training program
8 week cognitive training program

Locations

Country Name City State
United States Massachusetts General Hospital Boston Massachusetts

Sponsors (3)

Lead Sponsor Collaborator
Massachusetts General Hospital National Institute on Aging (NIA), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in brain structure Gray matter structure will be assessed before and after the 8 week programs. 8 weeks
Primary Change in brain activity during a memory test Brain activity during a memory task will be assessed before and after the 8 week programs. 8 weeks
Secondary 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. baseline, 8 weeks, 12 and 24 months
Secondary 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. 2 years
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