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O estudo clínico NCT06953167 (CPLS) para Alzheimer's Disease (AD) está em recrutamento. Consulte a visualização em cartões do Radar de Estudos Clínicos e as ferramentas de descoberta de IA para ver todos os detalhes. Ou pergunte qualquer coisa aqui. | ||
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Cognitive Health in Ageing Register: Investigational and Observational Trial Studies in Dementia Research (CHARIOT): Prospective Readiness Cohort (PRO) Longitudinal Study (CPLS) 600 Baseado em biomarcador Observacional Estilo de vida
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O estudo clínico NCT06953167 (CPLS) é um estudo observacional para Alzheimer's Disease (AD). Seu status atual é: em recrutamento. O estudo começou em 17 de março de 2025 e pretende incluir 600 participantes. Coordenado por Imperial College de Londres e deve ser concluído em 1 de fevereiro de 2029. Essas informações foram atualizadas no ClinicalTrials.gov em 21 de janeiro de 2026.
Resumo
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 ...Mostrar mais
Descrição detalhada
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,...
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Cognitive Health in Ageing Register: Investigational and Observational Trial Studies in Dementia Research (CHARIOT): Prospective Readiness Cohort (PRO) Longitudinal Study
Condições médicas
Alzheimer's Disease (AD)Outros IDs do estudo
- CPLS
- EDGE ID: 174407
- IRAS: 339745 (Outro identificador) (IRAS)
Número NCT
Data de início (real)
2025-03-17
Última atualização postada
2026-01-21
Data de conclusão (estimada)
2029-02
Inscrição (estimada)
600
Tipo de estudo
Observacional
Status
Em recrutamento
Palavras-chave
Alzheimer's disease
Dementia
Longitudinal Study
Biomarkers
CHARIOT-PRO
Amyloid
Cognition
Mild Cognitive Impairment
Dementia
Longitudinal Study
Biomarkers
CHARIOT-PRO
Amyloid
Cognition
Mild Cognitive Impairment
Braços / Intervenções
| Grupo de participantes/Braço | Intervenção/Tratamento |
|---|---|
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...Mostrar mais | N/A |
Desfecho primário
Desfecho secundário
| Medida de desfecho | Descrição da medida | Prazo |
|---|---|---|
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 |
| Medida de desfecho | Descrição da medida | Prazo |
|---|---|---|
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 |
Assistente de participação
Critérios de elegibilidade
Idades elegíveis
Idoso
Idade mínima
65 Years
Sexos elegíveis
Todos
Aceita voluntários saudáveis
Sim
To be eligible, participants must meet all inclusion criteria for the study, as follows:
- Male or Female, aged >65years
- 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.
- Have completed CPSS1 amyloid screening using either amyloid PET scanning or CSF Aβ42 measurement.
- Be fluent in and able to read and write in English and have adequate hearing and visual acuity to complete the required psychometric tests.
- 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.
- 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:
- 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.
- Unable to comply with the study-specific requirements.
- History of alcohol or drug dependence or abuse, as defined by the most current version of the DSM criteria within the last 3 years.
Sem dados de contato.
1 Locais do estudo em 1 países
Imperial College London, London, United Kingdom
Project Manager, Contato, +44 20 7594 3894, [email protected]
Em recrutamento