Clinical trial NCT02628548: Neural Correlates of Successful Cognitive Aging
Official title: Neural and Cognitive Changes Associated With Mental Training in Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute on Aging (NIA)
First posted: 2015-12-11
Enrollment: 175
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in brain structure
timeFrame: 8 weeks
measure: Change in brain activity during a memory test
timeFrame: 8 weeks
Secondary outcomes:
measure: Blood markers
timeFrame: baseline, 8 weeks, 12 and 24 months
measure: Change in cognition
timeFrame: 2 years
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Mass. General Hospital
name: Sara Lazar, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sevinc 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.