Improving detection and prevention of cognitive decline in ageing
| ISRCTN | ISRCTN42025084 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN42025084 |
| Secondary identifying numbers | 14719 |
- Submission date
- 31/07/2013
- Registration date
- 31/07/2013
- Last edited
- 12/02/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
The rapid and reliable identification of cognitive (thinking) changes has become more urgent as patients are presenting earlier with subjective memory loss and milder memory impairments. Early detection is therefore increasingly important for planning the clinical management of these diseases along with the use of protective strategies. The influence of early patterns of cognitive deficits and regional brain dysfunction on the development of behavioural symptoms in patients with dementia and stroke hasn’t been extensively studied. Early prediction of potential symptoms and their causes will improve the management of such patients. We aim to assess changes in smaller patient groups to find what determines response and non-response to treatment and better inform clinical practice. This study will establish local norms for cognitive tests and compile a database of assessments of patients with degenerative and vascular brain disease
Who can participate?
Volunteers aged over 18 with no history of neurological or psychiatric disorders, and patients aged over 18 who experience cognitive change as a result of neurodegenerative disease, vascular brain disease or dementia due to other causes.
What does the study involve?
The study is undertaken over a 5-year period. Patients are tested every 6 months and the progression of cognitive deficits is monitored to find patterns to identify the different forms of dementia, monitor the formation/development of abnormal beliefs, and assess and monitor the effects of non-drug treatments.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
Royal Hallamshire Hospital Neuropsychology Clinic (UK)
When is the study starting and how long is it expected to run for?
February 2013 to February 2018
Who is funding the study?
National Institute for Health Research (NIHR) (UK)
Who is the main contact?
Dr Katija Khan
kat.khan@sheffield.ac.uk
Contact information
Scientific
Academic Neurology Unit
Beech Hill Road
Sheffield
S10 2RX
United Kingdom
| kat.khan@sheffield.ac.uk |
Study information
| Study design | Randomised interventional trial; Design type: Screening |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Screening |
| Scientific title | Assessment of age and disease related cognitive impairment in normal volunteers and people with degenerative and vascular brain disease and assessment of the potential neuroplastic effect of non pharmacological treatment |
| Study objectives | The rapid and reliable identification of cognitive changes has become more urgent as patients are presenting earlier with subjective memory loss and milder memory impairments. Early detection is therefore increasingly important for planning clinical management of these diseases along with the employment of protective strategies like vascular risk factor and intensive cognitive stimulation which are gaining credibility. Influence of early patterns of cognitive deficits and regional brain dysfunction on the development of behavioural symptoms in patients with dementia and stroke hasnt been extensively studied. Early prediction of potential neuropsychiatric symptoms and their neurological causes will improve management of such patients. Also effects of non-pharmacological treatment for dementia have been studied mostly in large non controllable industry sponsored trials in poorly characterized groups of patients. Our centre aims at detailed assessment of changes in smaller patient groups to identify the determinants of response and non-response and better inform clinical practice. This research will establish local norms for cognitive tests and compile a database of clinical, neuropsychological and neuroimaging assessments of patients with degenerative and vascular brain disease referred to the Royal Hallamshire Hospital Neuropsychology Clinic. The research will be undertaken longitudinally over a 5yr period. Patients will be tested at 6mnth intervals and progression of deficits will be monitored to identify distinct neuropsychological patterns that permit early differentiation of different forms of dementia, monitor formation/development of abnormal beliefs, assess and monitor effects of non-pharmacological treatments. The data will be used to: establish the earliest cognitive impairments which strongly predict pathological brain aging, establish patterns of impairments after focal brain lesions useful in differential diagnosis, develop models of brain dysfunction. More details can be found at: http://public.ukcrn.org.uk/search/StudyDetail.aspx?StudyID=14719 |
| Ethics approval(s) | 12_YH_0474 |
| Health condition(s) or problem(s) studied | Topic: Dementias and Neurodegenerative Diseases Research Network; Subtopic: Dementia; Disease: Dementia |
| Intervention | Cognitive Stimulation, Face to Face interview and Psychometric tests, administered by experienced research neuropsychologists at Royal Hallamshire Hospital. |
| Intervention type | Other |
| Primary outcome measure | Resting state functional magnetic resonance imaging (fMRI); Timepoints: Baseline and at 6 month intervals |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/02/2013 |
| Completion date | 01/02/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | UK Sample Size: 500 |
| Key inclusion criteria | 1. Any volunteer with no history of neurological or psychiatric disorders, and fluent in English will be eligible for the study 2. Any patient who experiences cognitive change as a result of neurodegenerative disease, vascular brain disease or dementia due to other causes, and fluent in English may be included 3. Target Gender: Male & Female; Upper Age Limit 100 years ; Lower Age Limit 18 years |
| Key exclusion criteria | 1. Any volunteer with history of neurological or psychiatric disorders, substance abuse, persistent use of psychoactive drugs, history of traumatic brain injury with loss of consciousness, or non-fluent in English will not be eligible for inclusion 2. Patients with perceptual deficits or advanced dementia who are unable to complete assessments, or who are non-fluent in English, or patients who clearly lack capacity to give consent will not be eligible for inclusion |
| Date of first enrolment | 01/02/2013 |
| Date of final enrolment | 01/02/2018 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
S10 2RX
United Kingdom
Sponsor information
Hospital/treatment centre
South Yorkshire Cardiothoracic Unit
Northern General Hospital
Sheffield
S5 7AU
England
United Kingdom
| Website | http://www.sth.nhs.uk/ |
|---|---|
"ROR" |
https://ror.org/018hjpz25 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
12/02/2016: Plain English summary added.
