|Cohort name||Brains for Dementia Research|
|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|
|Study or database website|
|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: 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: 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: 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?||
Clinical staff: Research nurses and psychologists.
|Does this take place in participants' homes or at a central location?||
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|
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
|Age at time of diagnosis of dementia||No|
|Age at last follow-up||Yes|
|Age at time of death||Yes|
|Any physical examination performed?||Yes|
|Blood pressure||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.
|Cardiovascular disease data||No|
|Medication use for CVD||
Comments: Interview report - medical history
Comments: The study team are planning to add BP to the next round of visits.
Comments: Interview report - medical history.
|Virus testing||No data available|
Drug coding system: Interview report - medical history. Medication is coded using BNF codes.
|Any domain-specific cognitive test performed?||No|
|IQ data available?||No|
|Years of education||Yes|
|Level of education||Yes|
|Standard dementia global cognition scales?||Yes|
Subgroup: Discontinued, approximately N=300 are available.
|Addenbrooke's Cognitive Exam||No|
|Other assessments of global cognition||CERAD Clinical and Neuropsychology Assessment.|
Non-Cognitive Clinical Outcomes
|Lewy Body Disease||Yes|
|Dementia diagnosis (Other comments)||Yes|
|Functional rating scales|
|Any information on dementia rating collected?||Yes|
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).
|Blessed Dementia Scale||
|Clinical dementia rating scale (CDR)||
|Complex Activities of Daily Living||No|
|Functional Assessment Questionniare (FAQ)||No|
|Global Deterioration Scale (GDS)||
Comments: Scored within other assessments
|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|
|Beck Depression Inventory||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|
|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|
|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|
|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|
|Health service utilisation|
|Any Health Resource Utilisation Collected ?||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|
|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|
|Transient Ischemic Attack||Yes|
|Any head trauma data?||Yes|
|Loss of consciousness||Yes|
|Sports, soccer and boxing||No|
|Head trauma severity||No|
|BISQ or equivalent||No|
|CESD scale (depression)||No|
|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.|
|Blood Metabolic Analytes|
|CRP (c-reactive protein)||No|
|eGFR (estimated Glomular Filtration Rate)||No|
|Liver Function Tests||No|
|Other blood samples||No|
|Are laboratory protocols and storage information available for bloods||Yes|
Details: Brain banking.
|Are laboratory protocols and saliva storage information available?||No|
|Are CSF laboratory protocols and storage information available?||No|
|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|
Comments: Participants are asked what level of smoking: light, heavy, and asked about the duration of this.
Comments: Participants are asked what level of smoking: light, heavy, and asked about the duration of this.
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.|
|Other dietary items||No|
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||Data available|
|Socioeconomic status measures||
Comments: Postcodes are available, although this has not been specifically measured.
Ethics and 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.|
|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|
|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|
|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.|
|Consent for linkage to routine data|
|Which parts of the UK are represented by participants in your cohort?||