Cohort Descriptives

Variable Response
Cohort name Project Cygnus
Cohort acronym Cygnus
General Study Overview This study is a feasibility study which has a Longitudinal Cohort design, following up participants at selected time points over a 1 year duration. The study will recruit 2 distinct groups: (1) patients with symptoms of cognitive impairment, and (2) study partners who are cognitively normal. The patients recruited to group 1 will have been recently referred to a Memory Assessment Service by their GP with suspected Mild Cognitive Impairment (MCI) & mild dementia. All patients referred to a Memory Assessment Service for this reason will be potentially eligible for inclusion in the study. Close friends or family members involved in looking after the cognitively impaired participants will also be asked to participate as study partners to attempt to measure the impact that looking after a partner, friend or family member with memory problems can have on a carer’s Quality of Life and other variables such as financial burden. Both cognitively impaired participants and their study partners will be given the option of additionally participating in two sub-studies:
- Mobile data collection: Using a web/mobile app to collect self-reported data on a more regular basis from home
- Wearable device: Using a wearable device that looks like a watch to collect information on activity and sleep
Number of subjects at baseline 500
Institution name IXICO PLC., University of Manchester, Northern Health Science Alliance Network (NHSA)
City London, Manchester
Study or database website

http://www.ecygnus.com

Principal Investigator (PI): Name Derek Hill
PI: Address IXICO plc, 4th Floor Griffin Court, 15 Long Lane, London. EC1A 9PN
PI: email

derek.hill@ixico.com

PI: phone +44 20 3763 7490
Administrative Contact (AC): Name Francine Jury
AC: Address Genomics Research, Stopford Building, Oxford Road, Manchester, M13 9PT
AC: email Francine.jury@manchester.ac.uk
AC: phone 0161 275 1623
Technical Contact/Data manager (TC): Name Samuel Akinlabi
TC: email

samuel.akinlabi@ixico.com

Population based study? Yes
Family based study? Yes
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? Combination: In person, via questionnaire, via wearable device
Who carries out data collection? Interviewers
Clinicians
Clinical staff
Does this take place in participants' homes or at a central location? Both - wearables is ongoing, clinical measurements are taken and questionnaire used for base data collection
Do participants take part individually or are families/partners involved? Individually
Family
Dementia cases ascertained as part of study: Yes
Diagnosis based on review of existing clinical data Unknown
Was diagnosis/primary outcomes made blind to exposure variables? Unknown
How many times followed up? 3
Study start date 2016-04-01
Study end date 2017-09-30
Is study ongoing? Yes
Is study still recruiting? Yes
Inclusion criteria - Aged 18 years or older
- Partner, Family Member or Close Friend is a participant in CYGNUS in the cognitively impaired participant group
- English speaking/able to understand study documents
Exclusion criteria - Aged younger than 18 years
- Do not have capacity to consent
- Previously referred to a memory assessment service themselves

Demographic and Clinical Information

Variable Response
Demographics
Age Yes
Age at last follow-up Yes
Sex Yes
Ethnicity Yes
Education Yes
Physical examinations
Any physical examination performed? Yes
Weight Data available
Height Data available
Neurological examination Data available
Cardiovascular examination Data available
Respiratory examination Data available
Specify any others BMI
Medical conditions
Cardiovascular disease data Yes
Medication use Subgroup

Cognitive Outcomes

Variable Response
Any domain-specific cognitive test performed? Yes
Visual Memory Data available
Data available
Language Data available
Data available
Working memory Data available
Data available
Cognitive background? Yes
Years of education Yes
Standard dementia global cognition scales? Yes

Non-Cognitive Clinical Outcomes

Variable Response
Dementia diagnosis
Alzheimer's dementia Yes
Lewy Body Disease Yes
Huntingtons Disease Yes
Parkinsons Disease Yes
Frontotemporal dementia Yes
Vascular dementia Yes
MCI Yes
Subjective complaint Yes
Dementia diagnosis (Other comments) Not necessarily all the variables above will be existent, but they will be included if present in a participant.
Functional rating scales
Any information on dementia rating collected? Yes
Any information on subjective complaints collected? Yes
Memory Functioning Questionnaire Data available
Any neuropsychiatric rating scale administered? Unknown
Any Quality of Life Data Colllected? Yes
Quality of Life-Alzheimers Disease (QOL-AD) Yes
Specify any other quality of life scales EQ-5D-5L - study partners only
UCLA-3 Items Loneliness Scale - Both cognitively impaired participants and study partners
Any information on Caregivers and Caregiving Collected? Yes
Zairit Burden Yes
Specify any other caregiver scales Time Spent Caring - study partners only
Full Time Care - Cognitively impaired participants only
Health service utilisation
Any Health Resource Utilisation Collected ? Yes
Hospital utilisation Yes
Home care- domestic Yes
Home care- personal care Yes
Other neurological or psychiatric measurements? Yes
Any head trauma data? Yes

Imaging

Variable Response

Genetics

Variable Response
Overview
Gene screening

Biological samples

Variable Response
Blood collected No
Plasma No
Serum No
RNA No
DNA No
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 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
synuclein No

Brain donation

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

Lifestyle

Variable Response
Smoking Yes
Passive smoking Data available
Current smoking Data available
Former smoking Data available
Alcohol Data available
Drugs of abuse assessment
Obesity and associated risk factors
BMI Data available
Physical activity and exercise Yes
Employment status
Employment status Data available
Living situation
Living situation Data available
Socioeconomic status
Socioeconomic status measures Data available
Sleep assessment
Questionnaires Data available
Other sleep recording (specify) Pittsburgh Sleep Quality Index

Ethics and Engagement

Variable Response
Participant engagement
Is there participant representation in the governance of the cohort? - Patients were involved in the ICHOM Dementia Standard Set development. “In an effort to have more significant involvement of patients in our Standard Set development, we have expanded our interactions with patients and taken patient engagement to another level. All of our active Working Groups have involved patients through formalized patient focus groups to produce a list of outcome domains that have mattered most to them. Patient surveys developed through these groups have been distributed to patients through affiliated patient societies to assess their perspective on the final list of outcome domains to include in our Standard Sets. Our Breast Cancer group recently validated a patient survey with input from 959 patients”
Ethics
Disclosure
Recruitment
Consent and recontact
Is there consent for recontact? Yes
If so, under what conditions? When consent is taken participants will be asked to agree for personal details to be transferred to the co-ordinating centre at the University of Manchester and to the Study Sponsor, IXICO. This will be used to contact participants with updates about the project and to invite them to any related projects that are undertaken. Participants will be asked to specifically consent to being approached about further research.

Data Management

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