A Study of the clinical Utility, patient preference and cost benefit of Spect and PET-CT brain imaging in the Evaluation and Diagnosis of Alzheimer's Disease
| ISRCTN | ISRCTN49486383 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN49486383 |
| Secondary identifying numbers | 7622 |
- Submission date
- 12/05/2010
- Registration date
- 12/05/2010
- Last edited
- 21/09/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Not provided at time of registration
Contact information
Mrs Nicola Barnett
Scientific
Scientific
Institute for Ageing and Health
Newcastle University
Wolfson Research Centre
Campus for Ageing and Vitality
Newcastle upon Tyne
NE4 5PL
United Kingdom
| Phone | +44 (0)191 248 1322 |
|---|---|
| n.a.barnett@ncl.ac.uk |
Study information
| Study design | Multicentre non-randomised diagnosis cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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 |
| Study 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(s) | Newcastle & North Tyneside 1 Research Ethics Committee, 29/01/2010, ref: 09/H0906/88 |
| 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 |
| Primary outcome measure | 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 study start date | 01/04/2010 |
| Overall study end date | 31/12/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | Planned sample size: 100; UK sample size: 100 |
| 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 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
- England
- United Kingdom
Study participating centre
Newcastle University
Newcastle upon Tyne
NE4 5PL
United Kingdom
NE4 5PL
United Kingdom
Sponsor information
Northumberland, Tyne and Wear NHS Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
St Nicholas Hospital
Jubilee Road
Gosforth
Newcastle Upon Tyne
NE3 3XT
England
United Kingdom
| Ali.Zaatar@ntw.nhs.uk | |
| Website | http://www.ntw.nhs.uk |
"ROR" |
https://ror.org/01ajv0n48 |
Funders
Funder type
Government
National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) Programme
No information available
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 07/09/2015 | Yes | No |
Editorial Notes
21/09/2017: Publication reference added.
