NCT02628548

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
175

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 30, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 11, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

January 18, 2016

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

September 7, 2022

Status Verified

September 1, 2022

Enrollment Period

6 years

First QC Date

November 30, 2015

Last Update Submit

September 2, 2022

Conditions

Aging

Outcome Measures

Primary Outcomes (2)

  • Change in brain structure

    Gray matter structure will be assessed before and after the 8 week programs.

    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.

    8 weeks

Secondary Outcomes (2)

  • Blood markers

    baseline, 8 weeks, 12 and 24 months

  • Change in cognition

    2 years

Study Arms (2)

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.

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.

Behavioral: Cognitive training program

Interventions

Cognitive training programBEHAVIORAL

8 week cognitive training program

Cognitive training program 1Cognitive training program 2

Eligibility Criteria

Age65 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • years of age
  • Right-handed

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02129, United States

Location

Related Publications (1)

  • 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.

    PMID: 34512305DERIVED

Study Officials

  • Sara Lazar, PhD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Research Scientist

Study Record Dates

First Submitted

November 30, 2015

First Posted

December 11, 2015

Study Start

January 18, 2016

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

September 7, 2022

Record last verified: 2022-09

Locations

US(1)