nderstanding Brain Inflammation in Cognitive Problems (BRIC)
- Conditions
- Dementia with Lewy bodiesNervous System Diseases
- Registration Number
- ISRCTN11195489
- Lead Sponsor
- ewcastle upon Tyne Hospitals NHS Foundation Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 110
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
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
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Brain Mitochondrial Translocator Protein (TSPO) is measured by 18F-DPA714 binding (mean cortical and regional) at baseline and 2 years
- Secondary Outcome Measures
Name Time Method 1. Peripheral blood inflammatory profile is measured by flow cytometry of cells and analysis of inflammatory markers at baseline, 1 year and 2 years<br>2. Cognition is measured using the Mini Mental State Examination (MMSE) and Montreal Cognitive Assessment (MoCA) at baseline, 1 year and 2 years <br>3. Global functional impairment is measured using the Clinical Dementia Rating Scale Sum of Boxes at baseline, 1 year and 2 years