Cohort Descriptives

Variable Response
Cohort name AMyloid imaging for Phenotyping LEwy body dementia
Cohort acronym AMPLE
General 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.
Number of 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 or database website

Principal Investigator (PI): Name Prof John O'Brien
PI: Address School of Clinical Medicine, Box 189, Level E4 Cambridge Biomedical Campus, Addenbrooke's Hospital, Cambridge, CB2 0QQ
PI: email

PI: phone +44 (0)1223 760682
Administrative Contact (AC): Name Ms Nicky Barnett
AC: Address Institute of Neuroscience, Newcastle University Campus for Ageing and Vitality, Newcastle upon Tyne, NE4 5PL
AC: email
AC: phone 0191 208 1322
Technical Contact/Data manager (TC): Name Clinical and cognitive information: Nicky Barnett. For imaging: Dr Michael Firbank: Tel 0191 208 1319
TC: Address Institute of Neuroscience, Newcastle University Campus for Ageing and Vitality, Newcastle upon Tyne, NE4 5PL
TC: email For imaging: Dr Michael Firbank:

TC: phone 0191 208 1322
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
Clinical staff
Does this take place in participants' homes or at a central location? Home
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 2013-04-02
Is study ongoing? Yes
Is study still recruiting? Yes
Inclusion criteria All Participants:
Age 60+.
Sufficient English to carry out cognitive testing.
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.

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.

Demographic and Clinical Information

Variable Response
Age Yes
Age at time of diagnosis of dementia Yes
Age at last follow-up Yes
Age at time of death No: Unless the person is still in study at time of death.
Sex Yes
Ethnicity No
Education Yes
Physical examinations
Any physical examination performed? Yes
Blood pressure Data available
Neurological examination Data available
Extrapyramidal symptoms Data available
Comments: UPDRS III
Heart Rate Data available
Gait assessment Data available: UPDRS III (Goetz et al., 2008).
Opthalmic examination Data available: Self report of visual hallucinations
Nerve conduction Data available: cranial nerve assessement
Specify any others Speech, tendon reflexes, level of consciousness recorded.
Self report of neurological symptoms, sleep recorded, nightmares recorded.
Medical conditions
Cardiovascular disease data Yes: If self reported in clinical interview.
Myocardial infarction Comments: If self reported in clinical interview.
Medication use for CVD Comments: If self reported in clinical interview.
Hypertension Data available: If self reported in clinical interview.
Systolic/diastolic BP Data available
Hypotension Comments: If self reported in clinical interview.
Hypercholesterolemia Yes: If self reported in clinical interview.
Virus testing No data available
Olfactory sensitivity No
Medication use Yes
Cancer Data available
Diabetic Status Data available

Cognitive Outcomes

Variable Response
Any domain-specific cognitive test performed? Yes
Verbal Memory Data available
Data available
N (estimate): 80 total target- controls, AD and LBD.
List all tests: Rey Auditory Verbal Learning Test
Pen and paper
Visuospatial Function Data available
Data available
N (estimate): 80 total target- controls, AD and LBD.
List all tests: David Salmon computerised Motor Integration test (Matlab environment).
Computerised: Matlab
Attention Data available
Data available
N (estimate): 80 total target- controls, AD and LBD.
List all tests: Trails A & B
Pen and paper
Reaction time Data available
Data available
N (estimate): 80 total target- controls, AD and LBD.
List all tests: Simple Reaction time and Choice Reaction time
Computerised: Simple (V) and Choice (< or >)
Language Data available
Data available
N (estimate): 80 total target (AD, LBD, controls).
Comments: Repeated collection.
List all tests: Graded Naming Test (McKenna and Warrington), FAS test of verbal fluency, Rey Auditory Verbal Learning Test.
Pen and paper
Vigilance Data available
Data available
N (estimate): 80 total target (AD, LBD, controls).
List all tests: Digit Vigilance: participants have to press a button whenever the see the number 9
Working memory Data available
Data available
N (estimate): 80 total target- controls, AD and LBD.
List all tests: Trails B
Pen and paper
Other cognitive tasks Angle discrimination test - computerised on Matlab.
David Salmon Motor Integration Test (baseline version only).
IQ data available? No
Cognitive background? Yes
Years of education Yes
Level of education Yes
Parental education No
Standard dementia global cognition scales? Yes
Repeated Collection
Addenbrooke's Cognitive Exam Yes
Repeated Collection: ACE-III (Mioshi et al., 2006).
3MS No
Other assessments of global cognition Clinician Assessment of Fluctuating confusion and quality of consciousness (Walker et al., 2000). Carried out with informant.
Dementia Cognitive Fluctuation Scale (DCFS-R).
Repeated collection at 1 year follow up.

Non-Cognitive Clinical Outcomes

Variable Response
Dementia diagnosis
Alzheimer's dementia Yes
Lewy Body Disease Yes
Huntingtons Disease No
Parkinsons Disease No
Frontotemporal dementia No
Vascular dementia No
Subjective complaint No
Dementia diagnosis (Other comments) No
Functional rating scales
Any information on dementia rating collected? Yes
Blessed Dementia Scale No
Clinical dementia rating scale (CDR) No
Complex Activities of Daily Living No
Dependence Scale No
Functional Assessment Questionniare (FAQ) No
Global Deterioration Scale (GDS) No
Katz ADL No
Lawton IADL Yes
Repeated Collection
PDQ39 (PD specific) No
UPDRS (PD specific) Yes
Repeated Collection
Comments: UPDRS III only
Hoehn and Yahr (PD specific) No
Schwab and England (PD specific) No
UHDRS (HD specific) No
Specify any other dementia rating scales 'Clinician Assessment of Fluctuating confusion and quality of consciousness' from Walker et al., 2000 and carried out with informant.
The Dementia Cognitive Fluctuation Scale (DCFS-R).
'Questionnaire for symptoms suggestive of Lewy Body Disease'.
Any information on subjective complaints collected? No
Any neuropsychiatric rating scale administered? Yes
Aggression Scale No
Beck Depression Inventory No
Behave-AD No
Center for Epidemiologic Studies Depression scale (CES-D) No
Connor-Davidson Resilience Scale No
Cornell depression Scale No
Geriatric Depression Scale (GDS) Yes
Hamilton depression rating scale (HDRS) No
Montgomery-Asberg depression scale (MADRS) No
Speilberger State Anxiety Scale No
Hospital anxiety depression scale/psychiatry (HADS) No
Specify any other scales No
Any Quality of Life Data Colllected? Yes
Quality of Life-Alzheimers Disease (QOL-AD) No
Dementia Quality of Life Instrument (DEMQOL) No
Discomfort Scale for Dementia of Alzheimers Type (DS-DAT) No
Progressive Deterioration Scale (PDS) No
Quality of Life in Late-Stage Dementia Scale (QUALID) No
Bedfords Alzheimers Nursing Severity Scale(BANS-S) No
Short Form (SF) 36 No
Health Utilities Index 1, 2 or 3 No
Specify any other quality of life scales Bristol Activities of Daily Living Rating Scale (BADL).
Any information on Caregivers and Caregiving Collected? No
Caregivers for Alzheimers disease Problems Scale (CAPS) No
Community Dementia Quality of Life Profile (CDQLP) No
Dementia Management Strategies Scale (DMSS) No
Caregiver Activity Survey (CAS) No
Quality of life of caregivers (CQOL) No
Screen for Caregiver Burden/Time Spent Caregiving (TSC) No
Work Productivity and Activity Impairment Questionnaire-dyad version (WPAI-DYAD) No
Zairit Burden No
Health service utilisation
Any Health Resource Utilisation Collected ? Yes
Hospital utilisation No
Prescription Medicine Cost No
Over the Counter Drug Costs No
Nursing Home Costs No
Costs of Visits to Specialists (out-patient) No
Costs of Home-Care No
Admission to nursing home No
Admission to home care No
Day care at nursing home No
Day care at home for elderly No
Home care- domestic No
Home care- personal care No
Home care- nursing No
Physical therapist No
Care of community mental health team No
Permanent stay at nursing home No
Informal ADL care No
Informal iADL care No
Days of work absence if having a paid job No
Other neurological or psychiatric measurements? Yes
Any stroke data? No
Stroke type No
Transient Ischemic Attack No
Carotid plaques No
Any head trauma data? No
Sports, soccer and boxing No
BISQ or equivalent No
Psychiatric evaluations Yes
CESD scale (depression) No
Personality evaluation Yes
Personality evaluation comments Comments: Self reported.
Apathy evaluation Yes
Anxiety measure No
Resilience evaluation No


Variable Response
For imaging data, what format(s) do you use for storing data? The PET / CT data is stored as both dicom and NIfTI. The MRI is stored as NIfTI and Philips PAR/REC files.
Structural T1 Acquired
N controls: 20
N patients: 20 AD, 40 DLB.
Manufacturer: Philips
Scanner N: Single
Field strength: 3T
Fluid attenuation inversion recovery (FLAIR) Acquired
N controls: 20
N patients: 20 AD, 40 DLB.
Manufacturer: Philips
Scanner N: Single
Field strength: 3T
Diffusion imaging (DTI/DWI) Acquired
Acquired: Processed using FSL software (
N controls: 20
N patients: 20 AD, 40 DLB.
Manufacturer: Philips
Scanner N: single
Field strengths: 3T
f-MRI (task) Not acquired
Not acquired
f-MRI (rest) Not acquired
Not acquired
PET Acquired
Acquired: Florbetapir. Single iv bolus of 370 MBq (10mCi) florbetapir (18F). Isotope paid for and provided by Avid Radiopharmaceuticals (Eli Lilly). Scans paid for by the study.
N controls: 20
N patients: 20 AD, 40 DLB
Scanner N: Single at Newcastle University PET system
SPECT Not acquired
Not acquired
MEG Not acquired
Not acquired
In vivo Spectroscopy Not acquired
Not acquired
Other (please specify) CT Axial head with FOV 500x500 mm (512x512 pixels), 221 x 1mm slices.
Do you use an imaging data management system (e.g. XNAT or LORIS)? No
Primary contact for the technical aspects of the imaging data Dr Michael Firbank:
Tel 0191 208 1319


Variable Response
Gene screening
Estimated N: 80 available by study end.
C9ORF72 No
TDP-43 No

Biological samples

Variable Response
Blood collected Yes
Plasma Yes
Serum Yes
Abeta 1-40 No
Abeta 1-42 No
Abeta x-40 No
Abeta x-42 No
Blood Metabolic Analytes
CRP (c-reactive protein) Yes
eGFR (estimated Glomular Filtration Rate) No
Glucose Yes
HbA1c No
Lipids No
Liver Function Tests Yes
Serum creatinine No
Homocysteine No
Folate Yes
Other blood samples No
Are laboratory protocols and storage information available for bloods Yes
Urine collection
Urine No
Autopsy data
Autopsy No
Measurements already performed No
Saliva collected No
Cortisol No
Are laboratory protocols and saliva storage information available? No
CSF collected Yes
Details: Taken at baseline only, yet to be analysed.
Are CSF laboratory protocols and storage information available? Yes
mtDNA abnormalities No
Oxidative stress No

Brain donation

Variable Response
Is brain donation part of the existing protocol? No
Are information sheets made available to representative or consultees? Yes
Are retrospective interviews carried out after the participant's death? No
Is there a procedure for declining donation/failed recruitment/project termination? No
Has an actuarial analysis been completed? No


Variable Response
Smoking Yes
Pack years Data available
Current smoking Data available
Former smoking Data available
Alcohol Data available
Units per day/week vs weekend Data available
Abstainers/former users Data available
Drugs of abuse assessment
Drugs of abuse assessment - Data available? Data available
Obesity and associated risk factors
Blood lipids Data available
Diet No
Other dietary items No
Employment status
Employment status Data available
Living situation
Living situation Data available
Socioeconomic status
Sleep assessment
Other sleep recording (specify) REM sleep disorder symptoms discussed with study doctor.

Ethics and Engagement

Variable Response
Participant engagement
Is there participant representation in the governance of the cohort? No.
Do existing mechanisms for consulting/involving participants exist? External PPI teams are available, namely 'Voice North'
If so, does this happen on an ongoing or an ad hoc basis? Ad hoc, for example, the team may consult with local PPI teams if there was a major ethics amendment.
Is there an ethics advisory or ELSI group within the cohort governance? No
If yes, who is represented on it? N/A
Does the cohort include participants who lack capacity? Yes
Is there a process in place for participants who lose capacity? Yes
Do participants provide contact information for a person to act as a potential consultee? Yes
Do procedures exist for the disclosure of incidental findings? Yes
What kinds of finding do these relate to? (imaging, genotyping, etc) Clinically relevant biochemistry, clinical or imaging findings.
Who is responsible for disclosing incidental findings? Imaging: radiologist paid to write a report, which is then passed to GP. The GP (and consultants) is kept informed of all information.
Do procedures exist for the disclosure of clinically relevant information identified as a direct focus of the study? (e.g. a diagnosis of dementia) Yes
How was the cohort recruited (NHS or not, primary or secondary care)? NHS secondary care via North East DeNDRON.
Does the study involve ongoing connections with participants' own doctors (e.g. GPs)? Yes
Consent and recontact
Is there consent for recontact? No

Data Management

Variable Response
Consent for linkage to routine data
Which parts of the UK are represented by participants in your cohort? England