Clinical trial NCT05128396: Successful Aging and Enrichment (SAGE)
Official title: Successful Aging and Enrichment (SAGE): Effects of Environmental Stimulation on Cognitive Health and Neuroplasticity
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cognitive Health
Healthy Aging
Keywords: aging
physical activity
cognitive stimulation
neural plasticity
mindfulness
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: Linnaeus University
First posted: 2021-11-22
Enrollment: 72
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: OTHER

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.

Detailed description: Study Procedures

Pre-Intervention Assessment The initial screening evaluation will take place over two half-day sessions, each lasting 3 to 3.5 hours in a designated room in the Laboratory of Healthy Cognitive Aging, Center for Brain/Mind Medicine, Brigham and Women's Hospital (BWH), 221 Longwood Avenue, Boston, Massachusetts (MA).

The sessions can be completed over one or two days, depending on the subject's preference.

Pre-Intervention Assessment Session 1 The first session will include completion of informed consent, a medical history, demographic information, including socioeconomic status (SES), survey questionnaires, and tests of visual acuity.

Screening Evaluation (for inclusion/exclusion)

Cognitive Screen

* The Mini-Mental State Examination (MMSE), a broad cognitive test on memory, spatial ability, memory and orientation, commonly used to screen for cognitive impairment
* American National Adult Reading Test (AmNART), a test of word pronunciation that provides an estimated IQ
* Logical Memory I and II, Wechsler Memory Scale-Third Edition, a test of verbal memory
* Boston Naming Test (Short-form, 15-items), a test of confrontation naming.

Depression Screen Geriatric Depression Scale

Neurological/Physical Evaluation Subjects will undergo a structured neurological examination. Height and weight will be obtained to calculate BMI. Visual acuity will be measured (Snellen wall chart).

Gait

Gait will be assessed through a procedure in which subjects walk 10 meters under two conditions:

1. Single task (walking at a comfortable pace)
2. Dual task (walking at a comfortable pace while simultaneously counting backwards by 3's, beginning with a 3 digit number told to the subject)

Every trial involving serial 3's will start from a different three digit number to reduce learning effects.

Subjects will be given an opportunity to carry out an untimed practice trial. Under the dual task condition, subjects will be instructed to perform as well as possible on both tasks (i.e., no specified prioritization). Each condition will be done 2 times, with the order counterbalanced across subjects. The first and last meter (gait start up and slow down) will not be counted in the measurements.

Time to walk 8 meters and number of steps taken will be measured. Under the dual task, investigators will also track how many numbers are generated while carrying out the serial 3's task (both correct and incorrect responses). In addition, the single task of counting backwards by 3's for 20 seconds will be tested twice in a seated position (once prior to and once after the gait testing).

Informant Questionnaire Subjects will select someone who knows them well (family member or friend) to complete a set of questionnaires. One questionnaire will provide information about a person's level of functioning (based on the Clinical Dementia Rating Scale), and another will inquire about a person's level of engagement (Apathy Scale). e questionnaires will be enclosed with a letter explaining how to complete the forms. The investigators will provide a stamped, addressed envelope to return the questionnaires to us. A backup plan will be to mail these materials directly to the informant selected. This would occur if the materials were misplaced or if the subject requests us to do so.

Eligibility criteria: Inclusion Criteria:

1. Be 65 or older
2. Have ≥ 8 years of education
3. 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)
4. Score above levels indicating possible cognitive impairment on the Mini Mental State Exam (MMSE) (≥ 26)
5. Have an estimated intelligence quotient (IQ) score ≥ 90 based on the American National Reading Test (AmNART)
6. Have a score within 2 standard deviations (SD) of the age-appropriate mean on the short form of the Boston Naming Test
7. Have a score within 2 SD of the age-appropriate mean on the Logical Memory Subtest of the Wechsler Memory Scale-Third Edition

Exclusion Criteria:

1. History of Central Nervous System (CNS) diseases or major psychiatric disorders based on Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria
2. Score of greater than 10 on the Geriatric Depression Scale
3. Corrected visual acuity worse than 20-50 as tested by a Snellen wall chart
4. Severe hearing disability that would interfere with their ability to participate in the experiments (e.g., to hear instructions and participate in cognitive testing)
5. Medical conditions (e.g., heart or pulmonary disease) that would prevent them from participating in the physical exercise training program
6. 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

Primary outcomes:
measure: Cambridge Neuropsychological Test Automated Battery (CANTAB), a computerized assessment of cognitive functions
timeFrame: Baseline
measure: Cambridge Neuropsychological Test Automated Battery (CANTAB), a computerized assessment of cognitive functions
timeFrame: End of Study - 5 weeks post-baseline
measure: Trail Making Test A
timeFrame: Baseline
measure: Trail Making Test A
timeFrame: End of Study - 5 weeks post-baseline
measure: Trail Making Test B
timeFrame: Baseline
measure: Trail Making Test B
timeFrame: End of Study - 5 weeks post-baseline
measure: Digit Symbol Coding, Weschler Adult Intelligence Scale (WAIS-IV)
timeFrame: Baseline
measure: Digit Symbol Coding, Weschler Adult Intelligence Scale (WAIS-IV)
timeFrame: End of Study - 5 weeks post-baseline
measure: Controlled Oral Word Association Test (COWAT)
timeFrame: Baseline
measure: Controlled Oral Word Association Test (COWAT)
timeFrame: End of Study - 5 weeks post-baseline
measure: Categorical Fluency
timeFrame: Baseline
measure: Categorical Fluency
timeFrame: End of study - 5 weeks post-baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.