Condition category
Mental and Behavioural Disorders
Date applied
31/07/2013
Date assigned
31/07/2013
Last edited
12/02/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Katija Khan

ORCID ID

Contact details

Academic Neurology Unit
Beech Hill Road
Sheffield
S10 2RX
United Kingdom
-
kat.khan@sheffield.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

14719

Study information

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

Acronym

Study hypothesis

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 hasn’t 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

12_YH_0474

Study design

Randomised interventional trial; Design type: Screening

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Screening

Patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

Resting state functional magnetic resonance imaging (fMRI); Timepoints: Baseline and at 6 month intervals

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/02/2013

Overall trial end date

01/02/2018

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

UK Sample Size: 500

Participant 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

Recruitment start date

01/02/2013

Recruitment end date

01/02/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Academic Neurology Unit
Sheffield
S10 2RX
United Kingdom

Sponsor information

Organisation

Sheffield Teaching Hospitals NHS Trust (UK)

Sponsor details

South Yorkshire Cardiothoracic Unit
Northern General Hospital
Sheffield
S5 7AU
United Kingdom

Sponsor type

Hospital/treatment centre

Website

http://www.sth.nhs.uk/

Funders

Funder type

Government

Funder name

National Institute for Health Research (NIHR) (UK) Grant Codes: 601055

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

12/02/2016: Plain English summary added.