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治験 NCT05128396 (SAGE)（対象：Cognitive Health、健康な老化）は実施中／登録終了です。詳細は治験レーダーのタイル表示と AI 発見ツールで確認するか、ここで質問してください。
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Successful Aging and Enrichment (SAGE)

実施中／登録終了
治験(臨床試験)の詳細は主に英語で提供されています。しかし、治験レーダーAIが支援できます！「治験を説明」をクリックして、選択した言語で試験情報を表示し、議論してください。
治験番号 NCT05128396 (SAGE) は 介入研究 臨床試験 で、Cognitive Health、健康な老化 に関するものです。現在は 実施中／登録終了 で、2013年12月1日 から開始しています。72 名の参加者 の募集が計画されています。この治験は ブリガム・アンド・ウィメンズ病院 によって主催され、2026年12月1日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2025年11月24日 です。
概要
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.
詳細説明
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.

公式タイトル

Successful Aging and Enrichment (SAGE): Effects of Environmental Stimulation on Cognitive Health and Neuroplasticity

疾患／病気
Cognitive Health健康な老化
刊行物
この臨床試験について発表された科学記事と研究論文：
その他の研究識別子
  • SAGE
  • 2013P002266
NCT番号
NCT05128396
開始日
2013-12
最終更新日
2025-11-24
終了予定日
2026-12
目標参加者数
72
試験の種類
介入研究
治験の相・段階
該当なし
状況
実施中／登録終了
キーワード
aging
physical activity
cognitive stimulation
neural plasticity
mindfulness
主目的
その他
割付方法
無作為化
介入モデル
ファクトリアル割当
盲検化
なし（非盲検）
群（アーム）／介入
参加グループ/群介入/治療法
実薬対照薬Cognitive Training using Cogmed
Subjects will complete computerized cognitive training with varying degrees of difficulty over 5 weeks.
認知刺激
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.
実薬対照薬Awareness (mindfulness) training
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.
マインドフルネストレーニング
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.
実薬対照薬Physical Exercise Training Using an Interactive Video Platform
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.
身体活動
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.
プラセボ対照薬Low Level of Cognitive Training Using the Cogmed Program
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.
コントロールグループ
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.
主要評価項目
評価指標指標の説明時間枠
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
適格基準

対象年齢
高齢者
試験の最低年齢
65 Years
対象性別
全て
健康なボランティアを受け入れる
はい
  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

  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
Brigham and Women's Hospital logoブリガム・アンド・ウィメンズ病院395 件のアクティブな治験を探索
Linnaeus University logoLinnaeus University
責任者
Kirk Daffner, MD, 研究責任者, Chief, Division of Cognitive and Behavioral Neurology, Brigham and Women's Hospital
連絡先情報がありません。
1 1カ国の場所

Massachusetts

Brigham and Women's Hospital, Boston, Massachusetts, 02115, United States