Cohort Descriptives

Variable Response
Cohort name Brains for Dementia Research
Cohort acronym BDR
General Study Overview Brains for Dementia Research is an initiative funded jointly by the Alzheimer’s Society and Alzheimer’s Research UK to address the shortage of brain tissue that is so essential for research into dementia. Brain tissue is collected alongside clinical and cognitive information gathered in life. BDR currently networks six brain banks with standardised procedures for brain handling over the sites, ensuring consistency across the sites.
Number of subjects at baseline 3,200 (2,600 living approx). 70% control and 30% dementia (all dementias).
Institution name Newcastle University
Department name Brains for Dementia Research Coordinating Centre, Institute of Neuroscience
City Newcastle
Study or database website

http://www.brainsfordementiaresearch.org.uk/

Principal Investigator (PI): Name Alan Thomas
PI: Address Brains for Dementia Research Institute of Neuroscience and Newcastle University Institute for Ageing, Newcastle University, Biomedical Research Building Campus for Ageing and Vitality, Newcastle upon Tyne. NE4 5PL
PI: email

alan.thomas@newcastle.ac.uk

PI: phone 0191 208 1318
Administrative Contact (AC): Name Nicky Barnett
AC: Address Brains for Dementia Research Brains for Dementia Research Coordinating Centre Room EG02, Edwardson Building, Institute of Neuroscience, Newcastle University, Campus for Ageing and Vitality, Newcastle upon Tyne. NE4 5PL
AC: email N.a.barnett@newcastle.ac.uk
AC: phone 0191 208 2109
Technical Contact/Data manager (TC): Name Richard Cain
TC: Address Office 3.02 31 Great George St, Bristol, BS1 5QD
TC: email

richard.cain@bristol.ac.uk

TC: phone 0117 39 41721
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)? Yes
How is data collected? In person
Who carries out data collection? Interviewers
Clinical staff: Research nurses and psychologists.
Does this take place in participants' homes or at a central location? Home
Central: Assessments are carried out in participants homes and in BDR clinics. Some follow up interviews are conducted by telephone.
Do participants take part individually or are families/partners involved? Family: Study partner. Study partners are not consented, and the study partner may change over the course of the study.
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 2009-01-01
Is study ongoing? Yes
Is study still recruiting? Yes
Inclusion criteria Living in the UK.
Willingness to register for brain donation, and take part in widely used clinical and psychometric measures until the time for brain donation comes.
People with a diagnosis of dementia or MCI can register at any age, and those with no diagnosis of memory impairment can register from 65 years old.
Exclusion criteria Exclusion criteria are largely practical and related to the suitability of the donated brain tissue for research. This includes a diagnosis that indicates another brain bank might be more suitable, such as multiple sclerosis. Pre-existing conditions such as schizophrenia, bipolar disorder, brain tumours (including previous radiotherapy treatment to the head), major strokes, aneurysms, and other significant cerebrovascular incidents, can mean a person may not be an ideal ‘control’, or the brain structure is significantly changed. Infections such as meningitis, encephalitis, HIV, prion disease pose an infection risk to all coming in contact with the tissue, so also prevent brain donation.

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 Yes
Sex Yes
Ethnicity Yes
Education Yes
Physical examinations
Any physical examination performed? Yes
Blood pressure Data available
Opthalmic examination Data available
Assessed before onset of dementia
Comments: Self report about eye sight, use of glasses and contacts.
Specify any others Hip/waist measures and blood pressure added in a recent ethics amendment.
Hearing specifically asked about.
Medical conditions
Cardiovascular disease data No
Medication use for CVD Data available
Comments: Interview report - medical history
Systolic/diastolic BP Data available
Comments: The study team are planning to add BP to the next round of visits.
Hypotension Data available
Comments: Interview report - medical history.
Hypercholesterolemia No
Virus testing No data available
Olfactory sensitivity No
Medication use Yes
Drug coding system: Interview report - medical history. Medication is coded using BNF codes.
Cancer Data available
Diabetic Status Data available
Comments

Cognitive Outcomes

Variable Response
Any domain-specific cognitive test performed? No
IQ data available? No
NART No
Cognitive background? Yes
Years of education Yes
Level of education Yes
Parental education No
Standard dementia global cognition scales? Yes
MMSE Yes
Repeated Collection
MoCA Yes
Repeated Collection
ADAS-Cog Yes
Subgroup: Discontinued, approximately N=300 are available.
Addenbrooke's Cognitive Exam No
3MS No
GPCOG No
Other assessments of global cognition CERAD Clinical and Neuropsychology Assessment.

Non-Cognitive Clinical Outcomes

Variable Response
Dementia diagnosis
Alzheimer's dementia Yes
Lewy Body Disease Yes
Huntingtons Disease No
Parkinsons Disease No
Frontotemporal dementia Yes
Vascular dementia Yes
MCI Yes
Subjective complaint Yes
Dementia diagnosis (Other comments) Yes
Functional rating scales
Any information on dementia rating collected? Yes
ADCS-ADL Yes
Subgroup
Repeated Collection
Comments: There are approximately 90 completed ADLs. The Bristol Activities of Daily Living Scale will be used (or other common ADL scale such as ADCS-ADL if the participant is already part of another study using these measures).
ADCS-ADL-MCI No
Blessed Dementia Scale Yes
Repeated Collection
Comments
Clinical dementia rating scale (CDR) Yes
Repeated Collection
Complex Activities of Daily Living No
Dependence Scale No
Functional Assessment Questionniare (FAQ) No
FAST No
Global Deterioration Scale (GDS) Yes
Repeated Collection
Comments: Scored within other assessments
Katz ADL No
Lawton IADL No
PDQ39 (PD specific) No
UPDRS (PD specific) No
Hoehn and Yahr (PD specific) No
Schwab and England (PD specific) No
UHDRS (HD specific) No
Specify any other dementia rating scales The Bristol Activities of Daily Living Scale will be used (or other common ADL scale such as ADCS-ADL if the participant is already part of another study using these measures).
Hachinski Ischaemic Score, Moroney, J.T., Meta-analysis of the Hachinski Ischaemic Score in pathologically verified dementias. Neurology, 49, 1096 – 1105.
Any information on subjective complaints collected? Yes
Specify any other scales A free text section from the CAMDEX informant interview alllows for noting subjective complaints.
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 Yes
Geriatric Depression Scale (GDS) Yes
Hamilton depression rating scale (HDRS) No
Montgomery-Asberg depression scale (MADRS) No
NPI Yes
NPI-Q Yes
Speilberger State Anxiety Scale No
Hospital anxiety depression scale/psychiatry (HADS) No
Specify any other scales No
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 ? Yes
Hospital utilisation Yes
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 Yes
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? Yes
Stroke type No
Transient Ischemic Attack Yes
Carotid plaques Yes
Any head trauma data? Yes
Loss of consciousness Yes
Sports, soccer and boxing No
Head trauma severity No
BISQ or equivalent No
EEG No
Psychiatric evaluations Yes
CESD scale (depression) No
Personality evaluation No
Apathy evaluation No
Anxiety measure No
Resilience evaluation No

Imaging

Variable Response
Other (please specify) Some of the London group have been imaged as part of Simon Lovestone's biomarker cohort and this data theoretically could be requested.

Genetics

Variable Response
Overview
Gene screening

Biological samples

Variable Response
Blood collected Yes
Plasma Yes
Repeated Collection
Comments
Serum Yes
Repeated Collection
Comments
RNA Yes
Repeated Collection
Comments
DNA Yes
Repeated Collection
Comments
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 Yes
Urine collection
Urine No
Autopsy data
Autopsy Yes
Details: Brain banking.
Saliva
Saliva collected No
Cortisol No
Are laboratory protocols and saliva storage information available? No
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? Yes
Are information sheets made available to representative or consultees? Yes
Are retrospective interviews carried out after the participant's death? Yes
Is there a procedure for declining donation/failed recruitment/project termination? Yes
Has an actuarial analysis been completed? Yes

Lifestyle

Variable Response
Smoking Yes
Current smoking Data available
Comments: Participants are asked what level of smoking: light, heavy, and asked about the duration of this.
Former smoking Data available
Comments: Participants are asked what level of smoking: light, heavy, and asked about the duration of this.
Alcohol Data available
Abstainers/former users Data available
Comments: Participants are specifically asked if they have been a heavy drinker, and did the drinking ever cause life problems.
Drugs of abuse assessment
Obesity and associated risk factors
Hip/waist circumference Data available
Metabolic syndrome Comments: This is known if self-reported in medical history.
Diet No
Other dietary items No
Employment status
Employment status Data available
Comments: Participants are asked about their highest job ever held and that of the spouse and are asked about employment in the CAMDEX interview.
Living situation
Living situation Data available
Socioeconomic status
Socioeconomic status measures Data available
Comments: Postcodes are available, although this has not been specifically measured.
Sleep assessment

Ethics and Engagement

Variable Response
Participant engagement
Is there participant representation in the governance of the cohort? There is lay representation (not participants) on the committee.
Do existing mechanisms for consulting/involving participants exist? The participants have been asked how they found the research experience at some sites.
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, but the team run ethics training days for staff to ensure expertise in ethical issues throughout the study.
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
Disclosure
Do procedures exist for the disclosure of incidental findings? Yes
What kinds of finding do these relate to? (imaging, genotyping, etc) Post mortem this would include issues that have consequences for the family, eg finding out that someone had a diagnosis of Huntington's disease or of CJD.
Who is responsible for disclosing incidental findings? Post mortem with consequences for the family: the procedure would be agreed with REC and then the neuropathologist from the brain bank will report to the family. Research nurses may offer to have consultations with the family. The family can request a detailed post mortem report sent to their GP or a letter of diagnosis based on PM findings. Families will be informed that the post mortem results have been done and warned that a letter will be sent.
In life: research team discuss with the participant if depressed/cognitively impaired. The team would ask the participant if they would like the GP to be informed. If the participant refuses to pass information on to the GP, they are followed up with a phone call a few weeks later.
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
Recruitment
How was the cohort recruited (NHS or not, primary or secondary care)? For the most part, potential Brains for Dementia Research donors contact the coordinating centre for the project. Both the funding charities, the AS and ARUK have regular circulations to their membership and have featured the project in articles or as part of articles on other aspects of the charities involvement with dementia research. The Coordinating Centre is given as the contact point for anyone wishing to find out more about taking part, or to register their interest in taking part. People active in their support of dementia research in their communities provide information about the project in diverse places such as at carer and support groups, other organisations such as U3A, WI, and magazines aimed at an older readership. A previously ethically- approved leaflet has been produced in collaboration with the AS press team and lay volunteers and was designed so as to be accessible outside the healthcare professional setting. BDR have also benefitted from national press and radio coverage, and the funding charities, AS and ARUK, have given information and contact details for Brains for Dementia Research as part of articles about dementia in local press and radio. Brains for Dementia Research has a dedicated website with links from the Alzheimer's Society, Alzheimer's Research UK, MRC, HTA and other websites. The BDR website provides sufficient information to people with no memory impairment to consider brain donation, as normal or non−memory impaired control tissue is in extremely short supply. Another major avenue of recruitment is by word of mouth from our existing participants. Each collaborating centre has patient cohorts that are receiving longitudinal assessment as part of other research studies or standard care. These individuals (memory impaired and controls) and those without any other study involvement can pick up information in waiting areas (posters, leaflets) or be given information in clinics (leaflets) about Brains for Dementia Research.
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? Participants give consent on an assessment by assessment basis to ongoing participation in the study and also to receiving information about other relevant studies. Participants are asked to give consent for BDR to access research data that they may have provided to other projects/studies and medical/dental records as part of their consent form.

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