Dementia with Lewy bodies Nervous System Diseases
Conditions
Interventions
Current interventions as of 16/05/2025:
At the initial baseline assessment, consent and clinical assessment will be carried out over two visits, each taking 1-2 hours. This will include a blood test
Sponsors
University of Southampton
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: MCI-LB/DLB group: 1. Age =60 years 2. Fulfil criteria for probable MCI-LB (McKeith et al., 2020) or DLB (McKeith et al., 2017) 3. Capacity to consent to participation in the study 4. MMSE =20 5. If on cholinesterase inhibitors and/or memantine, stable dose for 3 months Control group: 1. Age =60 years 2. MMSE =27 3. No evidence of mild cognitive impairment or dementia
Exclusion criteria
Exclusion criteria: 1. Active systemic inflammatory disease 2. Active autoimmune disease 3. Taking immune system modifying medications (e.g., oral steroids or tumour necrosis factor inhibitors) 4. Taking incretin analogues (e.g., liraglutide), minocycline or other microglial suppressing agents 5. History of clinical stroke 6. Current major depression 7. History of bipolar disorder, non-organic psychosis (e.g., longstanding schizophrenia) or recurrent severe depression 8. Chronic migraine
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 16/05/2025: Peripheral blood inflammatory profile is measured by flow cytometry of cells and analysis of inflammatory markers at baseline, 1 year and 2 years. _____ Previous primary outcome measure: Brain Mitochondrial Translocator Protein (TSPO) is measured by 18F-DPA714 binding (mean cortical and regional) at baseline and 2 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 16/05/2025: 1. Cognition is measured using the Mini Mental State Examination (MMSE) and Montreal Cognitive Assessment (MoCA) at baseline, 1 year and 2 years. 2. Global functional impairment is measured using the Clinical Dementia Rating Scale Sum of Boxes at baseline, 1 year and 2 years. _____ Previous secondary outcome measures: 1. Peripheral blood inflammatory profile is measured by flow cytometry of cells and analysis of inflammatory markers at baseline, 1 year and 2 years 2. Cognition is measured using the Mini Mental State Examination (MMSE) and Montreal Cognitive Assessment (MoCA) at baseline, 1 year and 2 years 3. Global functional impairment is measured using the Clinical Dementia Rating Scale Sum of Boxes at baseline, 1 year and 2 years | — |
Countries
England, United Kingdom
Contacts
Public ContactJay Amin
Outcome results
None listed