The role of the immune system in early Lewy Body and Alzheimer’s disease

Not Applicable

• Conditions: Dementias and Neurodegeneration; Mental and Behavioural Disorders

• Registration Number: ISRCTN62392656
• Lead Sponsor: Cambridgeshire and Peterborough NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-06-28
• Last Update Posted: 18 June 2024
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 280

Inclusion Criteria

1. Diagnosis of:
1.1. Early Alzheimer's disease (including MCI or mild AD dementia)
1.2. Lewy body disease (including MCI-Lewy body type or mild DLB)
2. Cognitively normal for age and education with MMSE >26
3. Sufficient grasp of the English language to permit meaningful cognitive testing

Exclusion Criteria

1. Severe dementia so as to be unable to comply with study procedures or MMSE< 12
2. Concurrent major psychiatric illness, severe physical illness or comorbidity that may limit ability to fully participate, including inflammatory medical conditions or taking immunosuppressants (including oral steroids).
3. Absence of reliable informant (for patients)
4. Women who are pregnant or who are breastfeeding
5. Severe impairment of vision or hearing that would make assessments difficult
6. REM sleep behaviour disorder and/or late onset depression/anxiety (healthy control group only)

Study & Design

• Study Type: Interventional
• Study Design: Not specified