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BHC
Feasibility And Acceptability of a UK Based Remote Brain Health Clinic For Patients With Mild Cognitive Impairment (MCI)
Sponsor study identifier
observational
200
1 country
1
Study Start
June 20, 2022
Actual (reported)Primary Completion
December 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
June 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 20, 2022
Actual (reported)March 14, 2024
Actual (reported)April 23, 2024
Actual (reported)December 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
June 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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
To establish the acceptability and feasibility of the following procedures/ biomarker assessment in a Brain Health Clinic
Participants will be recruited via South London and Maudsley (SLaM) NHS Foundation trust memory services and referred by the memory clinic Psychiatrists.
King's College London
London, Denmark Hill, SE5 8AF, United Kingdom
Saliva and Plasma
Dag Aarsland
King's College London
First Submitted
March 14, 2024
First Posted
April 23, 2024
Study Start
June 20, 2022
Actual (reported)Primary Completion
December 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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
Contact the study team to confirm eligibility.
Study Completion
June 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
April 23, 2024
Record last verified: 2024-04
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Source: ClinicalTrials.gov.
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