רדאר קליני AI
הניסוי הקליני NCT06953167 (CPLS) עבור Alzheimer's Disease (AD) הוא מגייס. לכל הפרטים, עיינו בתצוגת הכרטיסים של רדאר ניסויים קליניים ובכלי הגילוי של AI. אפשר גם לשאול כל דבר כאן.
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תצוגת כרטיסים
חזרה לחיפוש

Cognitive Health in Ageing Register: Investigational and Observational Trial Studies in Dementia Research (CHARIOT): Prospective Readiness Cohort (PRO) Longitudinal Study (CPLS) 600 מבוסס סמנים ביולוגיים תצפיתי אורח חיים

מגייס
פרטי הניסויים הקליניים זמינים בעיקר באנגלית. רדאר קליני AI יכול לעזור! לחץ על 'הסבר את המחקר' כדי לצפות ולשוחח על מידע מהמחקר בשפה המועדפת עליך.
הניסוי הקליני NCT06953167 (CPLS) הוא מחקר מסוג תצפיתי עבור Alzheimer's Disease (AD), שנמצא כעת במצב מגייס. המחקר התחיל ב-17 במרץ 2025 ומתוכנן לכלול 600 משתתפים. המחקר מנוהל על ידי אימפריאל קולג' וצפוי להסתיים ב-1 בפברואר 2029. מידע זה עודכן לאחרונה באתר ClinicalTrials.gov ב-21 בינואר 2026.
סיכום קצר
Alzheimer's disease is a degenerative condition affecting the brain and is the most frequent form of dementia in older adults. Dementia is currently a major healthcare issue in the UK, affecting approximately a million people. The progression of the disease varies between individuals and the early stages may be characterised by only minimal changes in memory and thinking. These changes could remain undetected as the ...הצג עוד
תיאור מפורט
The aim of the study is to prospectively evaluate factors and markers associated with varying cognitive performance and longitudinal trajectories in individuals with differing levels of brain amyloid burden cross-sectionally as defined by PET imaging or Aβ42 CSF measurements (at CPSS1 screening), over a period of up to 12 years from CPSS1 screening.

Two C2N assays, i.e. the plasma Precivity AD2 and Multi-Tau assays,...

הצג עוד
כותרת רשמית

Cognitive Health in Ageing Register: Investigational and Observational Trial Studies in Dementia Research (CHARIOT): Prospective Readiness Cohort (PRO) Longitudinal Study

מצבים רפואיים
Alzheimer's Disease (AD)
מזהי מחקר נוספים
  • CPLS
  • EDGE ID: 174407
  • IRAS: 339745 (מזהה אחר) (IRAS)
מספר NCT
NCT06953167
תחילת המחקר (בפועל)
2025-03-17
עדכון אחרון שפורסם
2026-01-21
סיום המחקר (מוערך)
2029-02
משתתפים (מתוכנן)
600
סוג המחקר
תצפיתי
סטטוס
מגייס
מילות מפתח
Alzheimer's disease
Dementia
Longitudinal Study
Biomarkers
CHARIOT-PRO
Amyloid
Cognition
Mild Cognitive Impairment
זרועות / התערבויות
קבוצת משתתפים/זרועהתערבות/טיפול
Individuals who previously completed CHARIOT:PRO Substudy (CPSS1) screening.
All individuals who completed CPSS1 screening are well-characterised adults now aged \>65 years old, with documented measurement of amyloid load and a global CDR score of 0 at the time of CPSS1 screening (2015-2018). They completed all CPSS1 screening assessments including the PACC and RBANS cognitive batteries, physical and neurological evaluation, clinical laboratory tests, quantitative and functional brain MRI stu...הצג עוד
לא ישים
מדדי תוצאה ראשיים
מדד תוצאהתיאור המדידהטווח זמן
Change from baseline in the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Index scores
Raw scores are tallied for each of the 12 subtests and converted into five cognitive domain-specific Index scores (Immediate Memory, Delayed Memory, Language, Attention, Visuospatial Construction). Each Index score has a mean of 100 and an SD of 15, with a range of 40 to 160. Higher RBANS Index scores indicate better cognitive performance.
8.5 years
Change from baseline in the Preclinical Alzheimer Cognitive Composite (PACC) component scores
The raw score ranges for each test are as follows: Mini-Mental State Examination (MMSE): 0-30; Logical Memory (Wechsler Memory Scale) - Immediate Recall: 0-25; Delayed Recall: 0-25; Digit Symbol Substitution Test (DSST): 0-93; Free and Cued Selective Reminding Test (FCSRT) - Immediate Recall: 0-48 and Delayed Recall: 0-16; and Category Fluency (alternatively known as semantic fluency): 0-40. Across all PACC components, higher scores indicate better cognitive performance.
8.5 years
מדדי תוצאה משניים
מדד תוצאהתיאור המדידהטווח זמן
Change from baseline in the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Total Scale Score
RBANS raw scores are initially tallied for each of the 12 subtests and then converted into Index scores. These combined scores are further converted into a Total Scale Score, adjusted for age. The Total Scale Score is represented as a composite t-score with a mean of 100, a standard deviation (SD) of 15, and a range of 40-160. Higher RBANS Total scores indicate better cognitive performance.
8.5 years
Change from baseline in the Preclinical Alzheimer Cognitive Composite (PACC) composite score
Each component score will be transformed into a z-score. These z-scores will then be summed to form the PACC composite score. There is no fixed minimum or maximum for z-scores: a z-score of 0 represents average performance compared to a reference group; a negative z-score indicates below-average performance; and a positive z-score indicates above-average performance. Higher PACC composite scores indicate better cognitive performance.
8.5 years
עוזר השתתפות
קריטריוני זכאות

גילאים מוערכים למחקר
גיל שלישי
גיל מינימלי למחקר
65 Years
מגדרים מוערכים למחקר
הכל
מתנדבים בריאים מתקבלים
כן

  • To be eligible, participants must meet all inclusion criteria for the study, as follows:

    1. Male or Female, aged >65years
    2. Willing and having capacity (as assessed according to MCA 2005) to provide written informed consent and to participate in the study, OR (if lacking capacity) has a nominated consultee (as described in the MCA 2005 and Chapter 11 of the MCA Code of Practice 2007) who is able to advise that this is what the participant would have wished.
    3. Have completed CPSS1 amyloid screening using either amyloid PET scanning or CSF Aβ42 measurement.
    4. Be fluent in and able to read and write in English and have adequate hearing and visual acuity to complete the required psychometric tests.
    5. Be willing and able to adhere to the study visits and assessments specified in this protocol, and the reasonable requests and expectations of the study staff.
    6. Have a reliable informant - study partner (relative, partner, or friend) who is willing to provide their informed consent to participate, as a source of information. The study partner must be over 18 years old and should be fluent in and able to read and write in English. The informant must have sufficient contact with the participant and sufficient cognitive ability such that the Investigator feels that they can provide meaningful information about the participant's daily functioning. At a minimum, they must be in contact with the participant at least twice per month (in person, via telephone or other audio/visual communication). The study partner will be required in-person at the V1 visit. However, they can complete all subsequent visits remotely, or in-person if required.

  • To be eligible, participants must not meet any of the exclusion criteria for the study, as follows:

    1. Participant has any disability that would prevent completion of study procedures or assessments (e.g. blindness or significant visual impairment, deafness or significant hearing impairment, speech impairment, or sensory or motor dysfunction), or has any condition or situation/circumstance for which, in the opinion of the investigator, participation would not be in the best interest of the participant (e.g. compromise the participant's well-being), or that could prevent, limit, or confound the results of protocol-specified assessments and cognitive testing.
    2. Unable to comply with the study-specific requirements.
    3. History of alcohol or drug dependence or abuse, as defined by the most current version of the DSM criteria within the last 3 years.
Imperial College London logoאימפריאל קולג'
אין נתוני קשר.
1 מיקומי המחקר ב-1 מדינות
Imperial College London, London, United Kingdom
Project Manager, איש קשר, +44 20 7594 3894, [email protected]
מגייס