Successful Aging and Enrichment (SAGE)

NCT05128396 | Active Not Recruiting

• 1 other identifier: 2013P002266
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

Progress has been made in understanding the impact of different kinds of structured intervention programs in improving cognitive processing and performance in older adults, and in determining whether there is electrophysiological evidence for neuroplasticity in individuals over the age of 65.

Conditions

Cognitive Health; Healthy Aging

Keywords

aging; physical activity; cognitive stimulation; neural plasticity; mindfulness

Outcome Measures

Primary Outcomes (12)

• Cambridge Neuropsychological Test Automated Battery (CANTAB), a computerized assessment of cognitive functions

  * CANTAB Paired Associate Learning (PAL) - assesses visual memory and new learning * CANTAB Attention Switching Task (AST) - measures cued attentional set-shifting * CANTAB Reaction Time (RTI) - measures speed of response to visual target when the stimulus is either predictable (simple RT) or unpredictable (choice RT) * CANTAB Spatial Span (SSP) - assesses working memory * CANTAB One Touch Stockings of Cambridge (OTS) - a test of non-verbal reasoning

  Baseline

• Cambridge Neuropsychological Test Automated Battery (CANTAB), a computerized assessment of cognitive functions

  * CANTAB Paired Associate Learning (PAL) - assesses visual memory and new learning * CANTAB Attention Switching Task (AST) - measures cued attentional set-shifting * CANTAB Reaction Time (RTI) - measures speed of response to visual target when the stimulus is either predictable (simple RT) or unpredictable (choice RT) * CANTAB Spatial Span (SSP) - assesses working memory * CANTAB One Touch Stockings of Cambridge (OTS) - a test of non-verbal reasoning

  End of Study - 5 weeks post-baseline

• Trail Making Test A

  Tests of visual attention and task switching Timed task - Max time allotted: 150 seconds

  Baseline

• Trail Making Test A

  Tests of visual attention and task switching Timed task - Max time allotted: 150 seconds

  End of Study - 5 weeks post-baseline

• Trail Making Test B

  Tests of visual attention and task switching Timed task - Max time allotted: 300 seconds

  Baseline

• Trail Making Test B

  Tests of visual attention and task switching Timed - Max time allotted: 300 seconds

  End of Study - 5 weeks post-baseline

• Digit Symbol Coding, Weschler Adult Intelligence Scale (WAIS-IV)

  A test of processing speed 90 seconds allowed - Higher scores indicate faster processing speed Maximum Score: 91 Minimum Score: 0

  Baseline

• Digit Symbol Coding, Weschler Adult Intelligence Scale (WAIS-IV)

  A test of processing speed 90 seconds allowed - Higher scores indicate faster processing speed Maximum Score: 91 Minimum Score: 0

  End of Study - 5 weeks post-baseline

• Controlled Oral Word Association Test (COWAT)

  A test of verbal retrieval and word generation Total score is measured by calculating the total number of acceptable words produced for all three letters.

  Baseline

• Controlled Oral Word Association Test (COWAT)

  A test of verbal retrieval and word generation Total score is measured by calculating the total number of acceptable words produced for all three letters

  End of Study - 5 weeks post-baseline

• Categorical Fluency

  A test of rapid retrieval of semantic knowledge Scored by counting the number of correct unique semantic category items produced

  Baseline

• Categorical Fluency

  A test of rapid retrieval of semantic knowledge Scored by counting the number of correct unique semantic category items produced

  End of study - 5 weeks post-baseline

Study Arms (4)

Cognitive Training using Cogmed

ACTIVE COMPARATOR

Subjects will complete computerized cognitive training with varying degrees of difficulty over 5 weeks.

Behavioral: Cognitive Stimulation

Awareness (mindfulness) training

ACTIVE COMPARATOR

Subject participate in mindfulness training. The meditation and tasks will become increasingly more self-directed over the 5 weeks; the degree of guidance will decrease to keep the subjective effort approximately constant and moderately challenging through the 5 weeks.

Behavioral: Mindfulness training

Physical Exercise Training Using an Interactive Video Platform

ACTIVE COMPARATOR

Subjects will participate in a structured physical exercise training program that aims to progressively increase their level of activity over the 5 week training period.

Behavioral: Physical Activity

Low Level of Cognitive Training Using the Cogmed Program

PLACEBO COMPARATOR

Subjects will complete the same computerized training as the active cognitive arm over the course of 5 weeks, but the main difference is that for the control group task difficulty will remain at the same low starting level, rather than increasing over time.

Behavioral: Control Group

Interventions

Cognitive Stimulation BEHAVIORAL

During the initial session, a member of the research team will visit the subject's home and introduce the subject to the Cogmed training program (www.cogmed.com). Individuals will start at the same low difficulty level. As training proceeds, task difficulty will be individually adjusted based on performance by increasing/decreasing the number of items individuals have to remember, such that a participant reaches approximately 60% correct per day for each task. Each training session will start at the task difficulty level where the participant ended in the previous session. Performance and reaction time data will be continuously recorded while subjects are doing the task, and these data will be sent via the internet to the research team after each session. A member of the research team will communicate with each subject on a weekly basis (via phone call or email) to provide feedback and address any questions or concerns.

Cognitive Training using Cogmed

Mindfulness training BEHAVIORAL

The mindfulness meditations will be narrated by one guide and the tasks will be narrated by a different guide. We will have 7 mindfulness tasks in total, whose order of presentation will be counterbalanced across sessions: 1. mindful observing of place, 2. mindful eating, 3. mindful observing of object, 4. mindful observing of person, 5. mindful walking, 6. mindful listening, and 7. mindful writing with the non-dominant and dominant hand. At the end of each session, participants will write brief reflections stored via the website (e.g., an estimate of the amount of time subjects experienced their thoughts as wandering) both as an integral part of the mindfulness process and as a means of increasing the likelihood that subjects fully participate in each session. Each session will be structured as follows: Login, Mindfulness Meditation Session, Mindfulness Task 1, Mindfulness Task 2, Mindfulness Task 3, Write Log Reflection, Logout.

Awareness (mindfulness) training

Physical Activity BEHAVIORAL

Aerobic exercises will include relatively low impact activities like walking, jogging, or running in place, which will aim to put limited demands on balance. Each exercise will be explained and demonstrated in the video. All exercises can be done standing, sitting, or next to a chair that provides balance support as demonstrated in the videos. After the first session, for each subsequent session the difficulty level will start at one level below the previous session's average difficulty level (e.g. if they exercise at the most difficult level for most of the time during one session, the next session will start at the medium difficulty level). Each exercise will be explained and demonstrated in the video.

Physical Exercise Training Using an Interactive Video Platform

Control Group BEHAVIORAL

Individuals in the control group will participate in the same computerized Cogmed training program as described above. The main difference is that for the control group task difficulty will remain at the same low starting level, rather than increasing over time. The instructions given to subjects will be identical to the ones used in the cognitive training intervention.

Low Level of Cognitive Training Using the Cogmed Program

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Be 65 or older
• Have ≥ 8 years of education
• Be sufficiently fluent in the English language to understand instructions and perform the neuropsychological tests (as the purpose of the project is to study healthy aging)
• Score above levels indicating possible cognitive impairment on the Mini Mental State Exam (MMSE) (≥ 26)
• Have an estimated intelligence quotient (IQ) score ≥ 90 based on the American National Reading Test (AmNART)
• Have a score within 2 standard deviations (SD) of the age-appropriate mean on the short form of the Boston Naming Test
• Have a score within 2 SD of the age-appropriate mean on the Logical Memory Subtest of the Wechsler Memory Scale-Third Edition

You may not qualify if:

• History of Central Nervous System (CNS) diseases or major psychiatric disorders based on Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria
• Score of greater than 10 on the Geriatric Depression Scale
• Corrected visual acuity worse than 20-50 as tested by a Snellen wall chart
• Severe hearing disability that would interfere with their ability to participate in the experiments (e.g., to hear instructions and participate in cognitive testing)
• Medical conditions (e.g., heart or pulmonary disease) that would prevent them from participating in the physical exercise training program
• Evidence of substantial functional decline based on interview questions and completion of a questionnaire based on the Clinical Dementia Rating Scale by an informant who knows the subject well

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Linnaeus University: collaborator

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (6)

• Feng NC, Ryan E, Kidane M, Tusch ES, McFeeley BM, Carlsson R, Mohammed AH, Hakansson K, Daffner KR. Feasibility of an at-home, web-based, interactive exercise program for older adults. Alzheimers Dement (N Y). 2019 Nov 22;5:825-833. doi: 10.1016/j.trci.2019.10.005. eCollection 2019.

  PMID: 31799367 BACKGROUND

• Ledreux A, Hakansson K, Carlsson R, Kidane M, Columbo L, Terjestam Y, Ryan E, Tusch E, Winblad B, Daffner K, Granholm AC, Mohammed AKH. Differential Effects of Physical Exercise, Cognitive Training, and Mindfulness Practice on Serum BDNF Levels in Healthy Older Adults: A Randomized Controlled Intervention Study. J Alzheimers Dis. 2019;71(4):1245-1261. doi: 10.3233/JAD-190756.

  PMID: 31498125 BACKGROUND

• Simon SS, Tusch ES, Feng NC, Hakansson K, Mohammed AH, Daffner KR. Is Computerized Working Memory Training Effective in Healthy Older Adults? Evidence from a Multi-Site, Randomized Controlled Trial. J Alzheimers Dis. 2018;65(3):931-949. doi: 10.3233/JAD-180455.

  PMID: 30103334 BACKGROUND

• Tusch ES, Alperin BR, Ryan E, Holcomb PJ, Mohammed AH, Daffner KR. Changes in Neural Activity Underlying Working Memory after Computerized Cognitive Training in Older Adults. Front Aging Neurosci. 2016 Nov 8;8:255. doi: 10.3389/fnagi.2016.00255. eCollection 2016.

  PMID: 27877122 BACKGROUND

• Hakansson K, Ledreux A, Daffner K, Terjestam Y, Bergman P, Carlsson R, Kivipelto M, Winblad B, Granholm AC, Mohammed AK. BDNF Responses in Healthy Older Persons to 35 Minutes of Physical Exercise, Cognitive Training, and Mindfulness: Associations with Working Memory Function. J Alzheimers Dis. 2017;55(2):645-657. doi: 10.3233/JAD-160593.

  PMID: 27716670 BACKGROUND

• Simon SS, Tusch ES, Holcomb PJ, Daffner KR. Increasing Working Memory Load Reduces Processing of Cross-Modal Task-Irrelevant Stimuli Even after Controlling for Task Difficulty and Executive Capacity. Front Hum Neurosci. 2016 Aug 3;10:380. doi: 10.3389/fnhum.2016.00380. eCollection 2016.

  PMID: 27536226 BACKGROUND

MeSH Terms

Conditions

Motor Activity

Interventions

Exercise; Control Groups

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Division of Cognitive and Behavioral Neurology

Study Record Dates

• First Submitted: October 28, 2021
• First Posted: November 22, 2021
• Study Start: December 1, 2013
• Primary Completion: December 1, 2015
• Study Completion (Estimated): December 1, 2026
• Last Updated: November 24, 2025

Record last verified: 2025-11

Locations

US (1)