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

NCT06379594 | Enrolling By Invitation DMC

• 1 other identifier: 294633
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Mild Cognitive Impairment; Mild Cognitive Impairment Due to Alzheimer's Disease

Keywords

Remote Brain Health Clinic; Mild Cognitive Impairment; Old Age Psychiatry; Biomarkers; Dementia; Feasibility and acceptability

Outcome Measures

Primary Outcomes (2)

• To establish acceptability and feasibility of a novel remote brain health clinic for those with MCI.

  Number/ proportion of participants accepting each brain health clinic procedures for biomarker testing.

  From enrollment to the end of the final assessment at 12 months

• To establish acceptability and feasibility of a novel remote brain health clinic for those with MCI.

  Number/proportion of participant and study partner (where available) experience questionnaires on the acceptability and feasibility of remote brain health clinic

  From enrollment to the end of the final assessment at 12 months

Secondary Outcomes (8)

• 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 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

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be recruited via South London and Maudsley (SLaM) NHS Foundation trust memory services and referred by the memory clinic Psychiatrists.

You may qualify if:

• 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

You may not qualify if:

• A diagnosis of moderate-severe dementia
• Unwilling or unable to provide informed written consent to participate

Sponsors & Collaborators

• South London and Maudsley NHS Foundation Trust: lead

Study Sites (1)

King's College London

London, Denmark Hill, SE5 8AF, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

Saliva and Plasma

MeSH Terms

Conditions

Cognitive Dysfunction; Dementia

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Dag Aarsland

  King's College London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2024
• First Posted: April 23, 2024
• Study Start: June 20, 2022
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: April 23, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)