Feasibility And Acceptability of a UK Based Remote Brain Health Clinic For Patients With Mild Cognitive Impairment (MCI)
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- To establish acceptability and feasibility of a novel remote brain health clinic for those with MCI.
研究概览
简要总结
This project aims to understand the feasibility, acceptability and real-world evidence of a novel UK-based remote brain health clinic for patients with mild cognitive impairment (MCI). A timely and accurate diagnosis of dementia is a priority in the UK and MCI is indicative of future risk of cognitive decline. An accurate etiological diagnosis of MCI (MCI-subtyping - distinguishing those who are likely to go on to develop dementia and those who are not) is vital for treatment planning. Whilst the assessment of molecular biological markers (biomarkers) for etiological diagnosis of MCI and Alzheimer's disease (AD) is increasingly recommended and employed internationally, the uptake is low in UK memory clinics. The Brain Health Clinic (BHC) has been specifically designed as a state-of-the-art diagnostic centre for those with MCI. Procedures will include a range of clinical and biomarker assessments, with molecular biomarkers based on lumbar puncture and cerebrospinal fluid (CSF) analysis. Additionally, the clinic will employ remote neuropsychiatric assessments using digital and telephonic methods. This allows for regular contact, whilst adhering to changes in clinical practice and national guidance due to the COVID-19 pandemic. Our overarching objectives are to first establish the acceptability and feasibility of the remote Brain Health Clinic and its novel clinical and biomarker assessment programme. Then secondly establish the impact of care under the Brain Health Clinic on i) care management decisions (e.g. follow-up and treatment planning); ii) time to etiological diagnosis of MCI (MCI-subtyping); and iii) time to diagnosis of dementia and severity of dementia at the time of diagnosis.
详细描述
The Brain Health Clinic is designed to complement the existing memory clinic pathway and will complete the patient journey of patients with mild cognitive impairment (MCI). All patients referred to the new brain health clinic will be assessed using a standardized battery of clinical instruments by qualified clinicians, as per South London and Maudsley (SlaM) memory clinic pathway. In line with clinical practice changes and national guidance due to the COVID-19 pandemic, these assessments will be completed remotely via telephone and/or video conferencing and online.
Consenting participants will be invited to complete the Brain health Clinic's initial assessments. All assessments will be completed remotely. Assessments will include cognitive assessments such as Telephone Interview for Cognitive Status Modified version 39 (TICS-M v39), the Clinical Dementia Rating Scale Sum of Boxes (CDR-SoB) for telephone consultations, Computerised Integrated Cognitive Assessment (ICA-comp). The Hospital Anxiety and Depression (HADS) will be used to assess the symptoms of anxiety and depression. For the information from participants' carers/study partners, the following questionnaires will used: Amsterdam Instrumental Activities of Daily Living Questionnaire (A-IADL-Q), Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE); Adult Carer Quality of Life Questionnaire (AC-QoL) and Neuropsychiatric Inventory-Questionnaire (NPI-Q). Assessment battery can be completed in more than one session as required. Participants will be given the opportunity to complete self-assessments such as HADS in their own time, prior to the first assessment session.
Participants will be reviewed in the clinic at baseline, 6 and 12 months. A biomarker program consisting of lumbar puncture with cerebral spinal fluid (CSF) analysis following international guidelines (Engelborghs et al., 2017) saliva sampling, and electroencephalogram EEG will be applied to every consenting participant. This will be completed within two months of baseline assessment. A safety questionnaire for lumbar puncture will be administered to ensure eligibility for the procedure. The lumbar puncture facilities will be located in the BRC Clinical Research Facility. The CSF samples collected from the lumbar puncture will be shipped to Affinity Biomarker Labs where the analysis will be conducted using a Cobas® 6000 analyser for three assays: Elecsys® β-Amyloid(1-42) CSF, Elecsys® Phospho-Tau (181P) CSF, Elecsys® Total -Tau CSF. Consented samples for future studies will undergo centrifugation, transfer to new tubes, aliquoting into cryovials, and storage at -80 degrees Fahrenheit.
Saliva samples will be analysed by Cytox Group Limited, who will employ a polygenic risk scoring algorithm, genoSCORE™-LAB, to identify those at the highest genetic risk of cognitive decline and Alzheimer's disease using genetic data from the saliva sample (Daunt P et al. 2020). EEG will also be offered as an optional investigation to help support the diagnostic process. The EEG will be acquired by a trained researcher or neurophysiologist.
The consented participants will also be seen by a phlebotomy trained study researcher who will take blood plasma samples and store them at -80 degrees Fahrenheit.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Suspected Mild Cognitive Impairment requiring further diagnostic work-up to secure etiologic diagnosis, subjective cognitive impairment and mild dementia.
- •Aged 18 years or over
- •Fluent in the English language
排除标准
- •A diagnosis of moderate-severe dementia
- •Unwilling or unable to provide informed written consent to participate
结局指标
主要结局
To establish acceptability and feasibility of a novel remote brain health clinic for those with MCI.
时间窗: From enrollment to the end of the final assessment at 12 months
Number/proportion of participant and study partner (where available) experience questionnaires on the acceptability and feasibility of remote brain health clinic
次要结局
- To establish the acceptability and feasibility of the following procedures/ biomarker assessment in a Brain Health Clinic(From enrollment to the end of the final assessment at 12 months)
- 2. To establish the acceptability and feasibility of administering the following cognitive assessments remotely in a brain health clinic(From enrollment to the end of the final assessment at 12 months)
- To establish the impact of the remote Brain Health Clinics novel clinical and biomarker assessment programme(From enrollment to the end of the final assessment at 12 months)
- To establish the validity of novel MRI analysis software tools(Duration of the whole study period from June 20 2022 to June 20 2028)
- 5. To investigate the acceptability and feasibility of remote tablet-based cognitive training(From enrollment to the end of the final session at week 50)