Cohort Descriptives

Variable Response
Cohort Name AMyloid imaging for Phenotyping LEwy body dementia
Cohort Acronym AMPLE
Study Overview The principle aim of AMPLE is to undertake amyloid PET imaging in Lewy Body Dementia (LBD) and Alzheimer's disease (AD) participants and investigate the distribution of amyloid burden in LBD relative to AD and controls at baseline. A further aim is to determine the relationship between amyloid levels at baseline, clinical features of the disease, other imaging changes and subsequent clinical course in follow up.  Primary analysis would divide LBD patients into high and low amyloid burden with participants then compared on clinical features with AD-like symptoms and cognitive profiles
#Subjects at Baseline Target 80 (40 Lewy Body dementia, 20 controls, 20 Alzheimer's disease participants).
Institution Name Newcastle University
Department Name Clinical Ageing Research Unit
City Newcastle
Study/Database Website

http://www.ncl.ac.uk/caru/research/project/5055

Principal Investigator (PI) Prof John O'Brien
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)? No
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, Clinicians. Clinical Staff
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: Only as informants.
Dementia cases ascertained as part of study: Yes
Diagnosis based on review of existing clinical data Yes
Was diagnosis/primary outcomes made blind to exposure variables? No
How many times followed up? 1
How regular is follow-up? Annually
Study start date 4/2/2013 12:00:00 AM
Is study ongoing? Yes
Is study still recruiting? Yes
Inclusion criteria All Participants: Age 60+. Sufficient English to carry out cognitive testing. Controls: MMSE greater than or equal to 26. Lewy Body/AD Dementia: MMSE greater than or equal to 12. Meet criteria for probable LBD/AD. If taking anti-cholinesterase drugs or memantine, stable for at least 3 months. Presence of reliable informant sufficient to provide information for informant rated scales.
Exclusion criteria Concurrent major psychiatric illness (e.g. major depression). Severe physical illness or comorbidity that may limit ability to fully participate in study. Past history of excess alcohol intake. Past history of neurological illness including stroke. Contra-indications for MR or PET. Psychotropic medications which may significantly interfere with cognitive testing (anti- dementia drugs not an exclusion criteria). Controls: memory complaints or signs/ symptoms of dementia. Past history of Parkinson's disease. Psychotropic medications which may significantly interfere with cognitive testing (anti- dementia drugs not an exclusion criteria). Controls: memory complaints or signs/ symptoms of dementia. Past history of Parkinson's disease. Alzheimer's patients: Past history of Parkinson's disease. All Participants: Contra-indications for MR or PET imaging.Past history of excessive alcohol intake. Past history of other neurological illness including, but not limited to stroke, intracerebral pathology. Psychotropic and other medications which may significantly interfere with cognitive testing (including but not limited to sedative antidepressants, benzodiazepines except low when used as hypnotics, centrally acting anticholinergic drugs). Use of anti dementia drugs (eg anti-cholinesterase drugs or memantine) is not an exclusion criterion. A relevant history of severe drug allergy or hypersensitivity. Have ever participated in an experimental study with an amyloid targeting agent (e.g. anti-amyloid immunotherapy, or γ-secretase inhibitor) unless it can be documented that the subject received only placebo during the course of the trial. Receiving any investigational medications, or participation in a trial with investigational medications within the last 30 days. A radiopharmaceutical imaging or treatment procedure within 7 days prior to the study imaging session.

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
Age at time of death (only if the preson is still in study at the time of death) Y
Sex Y
Years of education Y
Level of education Y
Employment Status Y

Physical Health Status

Variable type Variables generally collected
Cardiovascular disease data Y
Myocardial infarction Y
Hypertension Y
Hypotension Y
Hypercholesterolemia (if self reported in clinical interview) Y
Systolic/Diastolic BP Y
Cancer Y
Diabetic Status Y
Level of consciousness recorded Y

Health Care Utilisation

Variable type Variables generally collected
Medication Use Y
Medication Use for CVD Y

Life Functionality

Variable type Variables generally collected
Lawton IDAL (Repeated collection) Y

Psychological Status

Variable type Variables generally collected
Self report of neurological symptoms Y
Sleep Recorded Y
Nightmares recorded Y
REM sleep disorder symptoms discussed with study doctor Y
NPI Y
BADL Y
Personality evaluation (self-reported) Y
Apathy evaluation Y

Mental Health Status

Variable type Variables generally collected
Psychiatric evaluations Y
Geriatric Depression Scale (GDS) Y

Cognitive Status

Variable type Variables generally collected
Alzheimer's Dementia Y
Lewy Body disease Y

Physical Environment

Variable type Variables generally collected
Living situation 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
Obesity: Blood lipids Y

Physical Examination

Variable type Variables generally collected
Blood pressure Y
Neurological examination Y
Extrapyramidal symptons (UPDRS III) Y
Heart rate Y
Gait assessment (UPDRS III) Y
Opthalmic examination (Self report of visual hallucinations) Y
Nerve conduction (Critical nerve assessment) Y
Speech Y
Tendon reflexes Y
UPDRS III (PD specific - Repeated collection) Y

Biosample Assays

Variable type Variables generally collected
Plasma Y
Serum Y
RNA Y
DNA Y
CSF: Subgroup - Taken at baseline only, yet to be analysed. 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
MMSE (Repeated collection) Y
Addenbrooke's Cognitive Exam (ACE-III - Repeated collection) Y
Dementia Cognitive Fluctuation Scale (DCFS-R) - (Repeated collection at 1 year follow up) Y

Imaging

Variable type Variables generally collected
Structural T1 Y
Fluid attention inversion recovery (FLAIR) Y
Diffusion imaging (DTI/DWI) Y
PET: Florbetapir  

Genomics

Variable type Variables generally collected
APOE Y

Metabolomics

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