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NCT06379594Enrolling by invitation

UK Based Remote Brain Health Clinic (BHC) for Patients With Mild Cognitive Impairment (MCI)

Feasibility And Acceptability of a UK Based Remote Brain Health Clinic For Patients With Mild Cognitive Impairment (MCI)

Source: ClinicalTrials.gov · Last updated 23 Apr 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Enrolling by invitation
Study type
Observational
Enrollment
200 (estimated)
First submitted
14 Mar 2024
Start date
20 Jun 2022
Primary completion date
31 Dec 2027
Lead sponsor
South London and Maudsley NHS Foundation Trust
NCT number
NCT06379594

What you commit to

  • Study type: Observational
  • Planned participants: 200
  • From 20 Jun 2022 to the primary completion date, 31 Dec 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • A diagnosis of moderate-severe dementia

Other

  • Unwilling or unable to provide informed written consent to participate

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
King's College London
Coordinator of this site? Confirm its status
LondonUnited KingdomUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.