Cohort Descriptives

Variable Response
Cohort name Platform for Research Online To investigate gEnetics and CogniTion and ageing
Cohort acronym PROTECT
General Study Overview The PROTECT Study is an online-based project that gathers research to improve understanding of the ageing brain and why some people develop dementia. Participants in PROTECT provide information such as demographics and lifestyle and complete online assessments to cognitive abilities. By repeating these assessments each year the study team are able to monitor change over the study. Participants also provide a sample of their DNA through a simple at-home kit.
Number of subjects at baseline 14,000
Institution name King's College London
Department name Institute of Psychiatry, Psychology and Neuroscience
City London
Study or database website

http://www.protectstudy.org.uk/

Principal Investigator (PI): Name Dr Anne Corbett
PI: Address Wolfson CARD, Kings College London, Wolfson Wing, Hodgkin Building, Guys Campus, London, SE1 1UL
PI: email

anne.corbett@kcl.ac.uk

PI: phone 0207 848 8185
Administrative Contact (AC): Name Zunera Khan
AC: Address Institute of Psychiatry, King's College London, Guy's Campus, London, United Kingdom SE1 1UL
AC: email Zunera.2.khan@kcl.ac.uk
AC: phone 0207 848 8071
Key study references

Open literature list

Population based study? Yes
Family based study? No
Clinical based sample? No
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)? Yes
How is data collected? Internet
Who carries out data collection? NA
Does this take place in participants' homes or at a central location? Home
Do participants take part individually or are families/partners involved? Individually
Dementia cases ascertained as part of study: No
Diagnosis based on review of existing clinical data No
Was diagnosis/primary outcomes made blind to exposure variables? No
Study start date 2014-04-01
Is study ongoing? Yes
Is study still recruiting? Yes
Inclusion criteria Aged 50 or over.
Resident in the United Kingdom.
Have not been diagnosed with dementia.
Exclusion criteria Unable to consent.
Established diagnosis of dementia.

Demographic and Clinical Information

Variable Response
Demographics
Age Yes
Age at time of diagnosis of dementia No
Age at last follow-up Yes
Age at time of death No
Sex Yes
Ethnicity Yes
Education Yes
Physical examinations
Any physical examination performed? Yes
Weight Data available
Assessed before onset of dementia
Comments: Self-report
Height Data available
Assessed before onset of dementia
Comments: Self-report
Medical conditions
Cardiovascular disease data No
Hypercholesterolemia No
Virus testing No data available
Olfactory sensitivity No
Medication use No
Cancer Data available
Comments: If self-reported
Diabetic Status Data available
Comments: If self-reported

Cognitive Outcomes

Variable Response
Any domain-specific cognitive test performed? Yes
Visual Memory Data available
Data available
N (estimate) : 14,000
List all tests: Wesnes Online Cognitive Testing System Picture Recognition
Computerised
Reaction time Data available
Data available
N (estimate): 14,000
List all tests: Simple and choice, Wesnes Online Cognitive Testing System Reaction time
Computerised
Associative learning Data available
Data available
N (estimate): 14,000
List all tests: Paired Associate Learning
Computerised
Language Data available
Data available
N (estimate): 14,000
List all tests: Baddeley Grammatical Reasoning Test, Wesnes Online Cognitive Testing System grammatical reasoning
Computerised
Vigilance Data available
Data available
N (estimate): 14,000
List all tests: Wesnes Online Cognitive Testing System Digit Vigilance
Computerised
IQ data available? No
Cognitive background? Yes
Years of education No
Level of education Yes
Parental education No
Standard dementia global cognition scales? No
MMSE No
MoCA No
ADAS-Cog No
Addenbrooke's Cognitive Exam No
3MS No
GPCOG No

Non-Cognitive Clinical Outcomes

Variable Response
Dementia diagnosis
Alzheimer's dementia No
Lewy Body Disease No
Huntingtons Disease No
Parkinsons Disease No
Frontotemporal dementia No
Vascular dementia No
MCI No
Subjective complaint No
Dementia diagnosis (Other comments) No
Functional rating scales
Any information on dementia rating collected? Yes
ADCS-ADL No
ADCS-ADL-MCI No
Blessed Dementia Scale No
Clinical dementia rating scale (CDR) No
Complex Activities of Daily Living No
Dependence Scale No
Functional Assessment Questionniare (FAQ) No
FAST No
Global Deterioration Scale (GDS) No
Katz ADL No
Lawton IADL Yes
PDQ39 (PD specific) No
UPDRS (PD specific) No
Hoehn and Yahr (PD specific) No
Schwab and England (PD specific) No
UHDRS (HD specific) No
Any information on subjective complaints collected? Yes
IQCODE Data available
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) No
Hamilton depression rating scale (HDRS) No
Montgomery-Asberg depression scale (MADRS) No
NPI No
NPI-Q No
Speilberger State Anxiety Scale No
Hospital anxiety depression scale/psychiatry (HADS) No
Specify any other scales Yes
Any Quality of Life Data Colllected? No
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
EQ-5DVAS No
Short Form (SF) 36 No
Health Utilities Index 1, 2 or 3 No
Any information on Caregivers and Caregiving Collected? No
Caregivers for Alzheimers disease Problems Scale (CAPS) No
Community Dementia Quality of Life Profile (CDQLP) No
COQoL-AD 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 ? No
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
EEG No
Psychiatric evaluations Yes
CESD scale (depression) No
Personality evaluation No
Apathy evaluation No
Anxiety measure Yes
Resilience evaluation No

Imaging

Variable Response
Structural T1 Not acquired
Not acquired
Fluid attenuation inversion recovery (FLAIR) Not acquired
Not acquired
Diffusion imaging (DTI/DWI) Not acquired
Not acquired
f-MRI (task) Not acquired
Not acquired
f-MRI (rest) Not acquired
Not acquired
PET Not acquired
Not acquired
SPECT Not acquired
Not acquired
MEG Not acquired
Not acquired
In vivo Spectroscopy Not acquired
Not acquired
Do you use an imaging data management system (e.g. XNAT or LORIS)? No

Genetics

Variable Response
Overview
Number Gwas subjects Comments
Comments: Planned
Gwas platform Psych-plus commercially available chips planned.
N Whole genome sequenced No
N samples not sequenced or genotyped Controls N
Controls N: 14,000
Comments: Planned
N not APOE genotyped Controls N
Controls N: 14,000
Comments: Planned
Gene screening
APOE No
TREM2 No
APP No
PSEN1 No
PSEN2 No
GRN No
MAPT No
C9ORF72 No
VCP No
CHMP2B No
TDP-43 No
PRNP No
SNCA No
LRRK2 No
PINK1 No
PARK2 No
NOTCH3 No
CST3 No
TTR No
GSN No
ITM2B No
HTT No
NPC1 No
NPC2 No

Biological samples

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

Brain donation

Variable Response
Is brain donation part of the existing protocol? No

Lifestyle

Variable Response
Smoking Yes
Current smoking Data available
Former smoking Data available
Comments
Alcohol Data available
Alcohol Use Disorders Identification Test (AUDIT) or other screen instrument (name) Data available
Comments: AUDIT-12
Binge drinking Data available
Drugs of abuse assessment
Drugs of abuse assessment - Data available? Data available
Obesity and associated risk factors
BMI Data available
Type of exercise: heavy, light Data available
Diet Yes
Employment status
Employment status Data available
Living situation
Living situation Data available
Socioeconomic status
Sleep assessment

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? There is a lay advisory group, which is based at the Maudsley, and there are a number of these people who are also participants.
If so, does this happen on an ongoing or an ad hoc basis? Ad hoc
Ethics
Is there an ethics advisory or ELSI group within the cohort governance? No
If yes, who is represented on it? NA
Does the cohort include participants who lack capacity? No
Is there a process in place for participants who lose capacity? Yes
Disclosure
Do procedures exist for the disclosure of incidental findings? Yes
What kinds of finding do these relate to? (imaging, genotyping, etc) Cognitive testing.
Who is responsible for disclosing incidental findings? "In the event that a significant drop in my performance on the cognitive tests is detected during the study I give permission for the study team to contact my GP to recommend further testing."
Do procedures exist for the disclosure of clinically relevant information identified as a direct focus of the study? (e.g. a diagnosis of dementia) No
Recruitment
How was the cohort recruited (NHS or not, primary or secondary care)? Online and word of mouth.
Does the study involve ongoing connections with participants' own doctors (e.g. GPs)? Yes
Consent and recontact
Is there consent for recontact? Yes
If so, under what conditions? "I give permission for members of the research team and the BioResource to contact me in the future to invite me to take part in other similar studies."

Data Management

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