Dementias and Neurodegeneration Mental and Behavioural Disorders
Conditions
Interventions
IMPRINT is a longitudinal study of early neurodegenerative cognitive disorders, with patients and healthy control volunteers. We will undertake blood, saliva, urine and CSF sampling together with clin
MCI-AD and MCI-DLB) and mild dementia stages, as well as in similarly aged healthy controls. Further clinical and cognitive follow-up, up to 3 years, will be undertaken to determine the impact on long
Sponsors
Cambridgeshire and Peterborough NHS Foundation Trust
University of Cambridge
Eligibility
Sex/Gender
All
Inclusion criteria
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
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of blood and cerebrospinal fluid (CSF) immune signatures to include proportions of immune cell subsets (monocytes, dendritic cells, granulocytes, and lymphocytes) measured by the mass cytometry time of flight in between groups (mild cognitive impairment [MCI] with Lewy body and dementia with Lewy bodies, MCI-Alzheimer’s disease [AD] and AD and controls) at baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Association between baseline immune signatures and: 1.1. Change in cognitive decline over time (ACE-III and other measures) Addenbrookes measured using the Cognitive Examination revised (ACE-R) test, ACE-III test, Montreal Cognitive Assessment test, Rey Auditory Verbal Learning Task, Trails A&B test at baseline and 18 months 1.2. Change in functional decline over time measured using the Bristol Activities of Daily Living Scale at baseline and 18 months 1.3. Progression from mild cognitive impairment to dementia measured using the Clinical Dementia Rating Scale at baseline and 18 months 1.4. Progression in non-cognitive symptoms: 1.4.1. Baseline and motor function measured using the Unified Parkinson’s disease rating scale part III scores at baseline and 18 months 1.4.2. Baseline and neuropsychiatric symptoms measured using the Neuropsychiatric inventory total and subscale scores, hospital anxiety and depression scale, geriatric depression scale, Pareidolia noise test and Feeling of Presence scores at baseline and 18 months 1.4.3. Other symptoms, including smell measured using the Brief Smell Identification Test (B-SIT), colour discrimination measured using the Farnsworth D-15 colour test, fluctuations measured using the Dementia cognitive fluctuations scale and Clinician Assessment of fluctuations at baseline and 18 months 1.5. Difference in proportions of immune cell subsets, including monocytes, dendritic cells, granulocytes, and lymphocyte subsets, measured using the mass cytometry time of flight at baseline and 18 months, and the association between these differences and the above scales | — |
Countries
England, United Kingdom
Outcome results
None listed