Cohort Descriptives

Variable Response
Cohort Name Identifying Predictors of dementia with Lewy bodies in People with Mild Cognitive Impairment
Cohort Acronym LewyPro
Study Overview The aim of this LewyPro is to identify people who may be in the early stages of developing Dementia with Lewy Bodies (DLB). Participants have MCI and symptoms of Lew Body Disease (LBD) and undergo a clinical examination, tests of their cognitive function, a specialised brain scan (FP-CIT), blood samples and a lumbar puncture. These people are then followed-up over the course of two years to see who develops DLB and see what factors at baseline assessment were associated with the development of DLB.
#Subjects at Baseline Target 100
Institution Name Newcastle University
Department Name Clinical Ageing Research Unit
City Newcastle
Principal Investigator (PI) Prof Alan Thomas
Population Based Study? No
Family Based Study? No
Clinical based sample? Yes
Is there follow-up data available? Yes
Were participants included prior to development of dementia (may refer to controls only)? Yes
Were participants included prior to development of MCI (may refer to controls only)? No
How is data collected? In person
Who carries out data collection? Interviewers and Clinicians: Study registrar and assistant psychologists.
Does this take place in participants' homes or at a central location? Home and Central
Do participants take part individually or are families/partners involved? Family: Partners only take part as informants.
Dementia cases ascertained as part of study: Yes
Diagnosis based on review of existing clinical data Yes
How many times followed up? 2
Study start date 1/1/2013 12:00:00 AM
Study end date 2/21/2016 12:00:00 AM
Is study ongoing? Yes
Is study still recruiting? Yes
Inclusion criteria LewyPro will recruit older adults (≥60 years old) with prodromal DLB, that is, people who have cognitive and non-cognitive symptoms consistent with Lewy body disease but do not have dementia (including MMSE ≥20 and CDR 0 or 0.5). This means subjects will meet MCI criteria (Winblad et al., 2004) and only one symptom characteristic of Lewy body disease:: MCI Criteria (Winblad et al., 2004): 1. Clinical evidence of subjective and objective cognitive decline. 2. No dementia. 3. Preserved basic activities of daily living. 4. Instrumental activities of daily living are minimally impaired or intact. Characteristic Symptoms of Lewy body disease: 1. Complex persistent visual hallucinations. 2. Spontaneous motor parkinsonism. 3. Cognitive fluctuations. 4. Severe neuroleptic sensitivity. 5. REM sleep behaviour disorder. In addition to these prodromal DLB criteria: Age ≥60. Stable medically, e.g. no delirium or recent changes (within last month) in prescribed medication. Mental Capacity to consent to research. Has provided written informed consent for participation in the study prior to any study specific procedures.
Exclusion criteria Clinical evidence of dementia. MMSE <20. CDR >0.5. Probable Dementia with Lewy Bodies. Parkinson’s Disease according to Queen Square Brain Bank Criteria. Probable Alzheimer’s disease (McKhann et al., 2011). Possible or Probable Vascular Dementia (Roman et al., 1993). Possible or Probable frontotemporal dementia (Rascovsky et al., 2011). History or evidence from neurological examination of clinical stroke. Diagnosis of a movement disorder or other serious neurological condition. Severe mental illness (major depression (current episode), bipolar disorder, schizophrenia). Pregnant or possibility of becoming pregnant.

Administration

Variable type Variables generally collected
Study ID Y
Age Y
Sex Y

Sociodemographic

Variable type Variables generally collected
Age Y
Age at time of diagnosis of dementia Y
Age at last follow-up Y
Sex Y
Years of education Y
Level of education Y
Employment status Y
Socioeconomic status measures Y

Physical Health Status

Variable type Variables generally collected
Cardiovascular disease data (If self reported in clinical interview) Y
Myocardial infarction (If self reported in clinical interview) Y
Medication use for CVD (If self reported in clinical interview) Y
Hypertension (If self reported in clinical interview) Y
Systolic/diastolic BP Y
Hypotension (If self reported in clinical interview) Y
Hypercholesterolemia (If self reported in clinical interview) Y
Cancer (If self reported in clinical interview) Y
Diabetic Status (If self reported in clinical interview) Y

Health Care Utilisation

Variable type Variables generally collected
Medication use (Drug Coding system) - If self reported in clinical interview. Y
Medication use for CVD (If self reported in clinical interview) Y

Life Functionality

Variable type Variables generally collected
Lawton IADL (Repeated collection) Y
UPDRS (PD specific) (Repeated collection) Y
UPDRS III Y

Psychological Status

Variable type Variables generally collected
Sleep assessment questionnaires Y

Mental Health Status

Variable type Variables generally collected
Geriatric Depression Scale (GDS) Y
NPI Y
Bristol Activities of Daily Living Scale Y

Cognitive Status

Variable type Variables generally collected
Lewy Body disease Y
MCI Y
Subjective complaint Y
Clinical dementia rating scale (CDR) Y

Lifestyle

Variable type Variables generally collected
Smoking Y
Pack years Y
Current smoking Y
Former smoking Y
Alcohol Y
Units per day/week vs weekend Y
Abstainers/former users Y
Drugs of abuse assessment Y

Physical Environment

Variable type Variables generally collected
Living situation Y

Physical Examination

Variable type Variables generally collected
Blood pressure (assessed before onset of dementia) Y
Weight (assessed before onset of dementia) Y
Height (assessed before onset of dementia) Y
Neurological examination (assessed before onset of dementia) Y
Extrapyramidal symptoms (UPDRS III) (assessed before onset of dementia) Y
Heart Rate (assessed before onset of dementia) Y
Gait assessment (UPDRS III) (assessed before onset of dementia) Y
Opthalmic examination (assessed before onset of dementia) Y
Clinical history structured interview with study doctor Y
BMI Y

Biosample Assays

Variable type Variables generally collected
Plasma (Repeated collection) Y
Serum (Repeated collection) Y
RNA (Repeated collection) Y
DNA Y
CSF collected (Subgroup) (Repeated collection) Y

Digital Phenotyping

Variable type Variables generally collected
Verbal memory Y
Visuospatial function Y
Attention Y
Reaction time Y
Language Y
Vigilance Y
Working memory Y
Angle discrimination test Y
David Salmon Motor Inegration Test (baseline only) Y
MMSE (Repeated collection) Y
Addenbrooke's Cognitive Exam - ACE-III (Repeated collection) Y
Clinical dementia rating scale (CDR) Y
Dementia Cognitive Fluctuation Scale (DCFS-R) Y
Clinician assessment of fluctuating confusion and quality of consciousness Y

Imaging

Variable type Variables generally collected
SPECT: FP-CIT DatSCAN Y

Genomics

Variable type Variables generally collected
APOE gene screening Y

Metabolomics

Variable type Variables generally collected
CRP (c-reactive protein) (Repeated collection) Y
Glucose (Repeated collection) Y
Liver Function Tests (Repeated collection) Y
Folate (Repeated collection) Y