Condition category
Mental and Behavioural Disorders
Date applied
12/05/2010
Date assigned
12/05/2010
Last edited
27/05/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mrs Nicola Barnett

ORCID ID

Contact details

Institute for Ageing and Health
Newcastle University
Wolfson Research Centre
Campus for Ageing and Vitality
Newcastle upon Tyne
NE4 5PL
United Kingdom
+44 (0)191 248 1322
n.a.barnett@ncl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

7622

Study information

Scientific title

A multicentre cohort study of the clinical utility, patient preference and cost benefit of single photon emission computed tomography (SPECT) and positron emission tomography computed tomography (PET-CT) brain imaging in the evaluation and diagnosis of Alzheimer's disease

Acronym

Suspected-AD

Study hypothesis

This study investigates which of two brain imaging techniques, single photon emission computed tomography (SPECT) or positron emission tomography combined with computed tomography (PET/CT) brain imaging, is more accurate in the diagnosis of different types of dementia (specifically Alzheimer's disease and dementia with Lewy bodies). We will recruit 100 subjects of both sexes who are aged over 60 years (40 with Alzheimer's disease, 30 with dementia with Lewy bodies, and 30 similarly aged controls) who will then undergo blood flow SPECT and glucose (FDG) PET/CT scanning.

The diagnostic accuracy of each scanning method compared to expert clinical diagnosis using validated criteria will be assessed. Scans will be assessed in a way similar to that used clinically, meaning that findings will be directly applicable to the wider NHS setting. We will also use questionnaires and willingness to pay methods to determine whether one scan is preferred over another by patients and carers. This study will be important in determining which form of brain imaging is best to use for assessing people with dementia, an important question since PET is much more expensive than SPECT and may prove slightly less acceptable to patients. The study will be conducted over a 3-year period (2 years for patient recruitment, one year for scan and data analysis).

More details can be found here: http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=7622

Ethics approval

Newcastle & North Tyneside 1 Research Ethics Committee, 29/01/2010, ref: 09/H0906/88

Study design

Multicentre non-randomised diagnosis cohort study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Topic: Dementias and Neurodegenerative Diseases Research Network; Subtopic: Dementia; Disease: Dementia

Intervention

Clinical assessment:
Motor features of parkinsonism will be assessed using the motor subsection of the Unified Parkinson's Disease Rating Scale (UPDRS III).

Cognitive assessment:
This will involve Cognitive testing with the Cambridge Cognitive Examination (CAMCOG), the Rey Auditory Verbal Learning Test) and executive function tests (verbal fluency and trails A & B). Standardised assessments of mood (Cornell scale for depression in dementia), neuropsychiatric features (Neuropsychiatric Inventory) and fluctuating attention will also be performed.

Imaging:
All participants will have a SPECT scan and a PET scan. Scans will be undertaken in a balanced order, so half of subjects will have the SPECT scan first followed by the PET, and half vice versa.

Preference questionnaires:
After each scan, patient and carer preference questionnaires will be administered. The carer would also be approached for a brief telephone interview 2 - 5 days after the scan.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Visual Reporting of scans (PET and SPECT), measured at baseline

Secondary outcome measures

1. Patient preference and cost, measured at end of recruitment phase
2. PET and SPECT maps compared for patients, measured at end of recruitment phase
3. Semi-automated region of interest analysis, measured at end of recruitment phase
4. Visual ratings of medial temporal lobe atrophy using the Scheltens scale, measured at end of recruitment phase
5. Visual ratings of scans on a semi-quantitative 4-point scale, measured at end of recruitment phase
6. Voxel based analysis using SPM5, measured at end of recruitment phase

Overall trial start date

01/04/2010

Overall trial end date

31/12/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. Diagnosis of probable Alzheimer's disease or probable dementia with Lewy bodies or healthy age matched controls
2. Aged over 60 years, either sex
3. Dementia patients to have mild to moderate dementia severity (mini mental state examination [MMSE] greater than 12)
4. Sufficient English to complete cognitive and psychiatric ratings

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

Planned sample size: 100; UK sample size: 100

Participant exclusion criteria

1. Physical disability that would render the patient unable to undergo PET and SPECT scanning
2. Contraindications to PET or SPECT scanning
3. Unwillingness to undergo scanning

Recruitment start date

01/04/2010

Recruitment end date

31/12/2012

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Newcastle University
Newcastle upon Tyne
NE4 5PL
United Kingdom

Sponsor information

Organisation

Northumberland, Tyne and Wear NHS Trust (UK)

Sponsor details

St Nicholas Hospital
Jubilee Road
Gosforth
Newcastle Upon Tyne
NE3 3XT
United Kingdom
-
Ali.Zaatar@ntw.nhs.uk

Sponsor type

Hospital/treatment centre

Website

http://www.ntw.nhs.uk

Funders

Funder type

Government

Funder name

National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) Programme

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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