Amyloid positron emission tomography (PET) imaging in the timely diagnosis of Alzheimer's disease
| ISRCTN | ISRCTN17685148 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17685148 |
| Protocol serial number | 18884 |
| Sponsor | Sussex Partnership NHS Foundation Trust |
| Funders | Avid Radiopharmaceuticals, Inc. (USA), Brighton and Sussex Medical School (UK) |
- Submission date
- 20/05/2015
- Registration date
- 20/05/2015
- Last edited
- 23/04/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Alzheimer’s disease (AD) is the most common type of dementia. It is most often characterised in its early stages by cognitive impairment, such as difficulty learning new things or trouble remembering. As it progresses, the symptoms of AD worsen due to the gradual death of brain cells. There are various factors considered to increase people’s risk of developing AD, particularly family history of AD and increasing age, however the exact cause of AD is unknown. Increasing evidence supports a role of abnormally accumulated amyloid protein in the brain, which is thought to contribute to the development of AD. The results of recent studies measuring amyloid protein in the brains of people with memory problems suspicious of AD has shown that about 25% of patients may incorrectly be diagnosed with AD. These patients either had normal amyloid protein levels in the fluid found in the brain and spine (cerebrospinal fluid (CSF)), or no amyloid protein was detected on positron emission tomography (PET) brain scans. Misdiagnosis can have a significant effect on patients and may stop further medical investigations to determine the real cause of memory impairment, missing a potentially treatable cause. Conditions such as depression (with or without alcoholism), and vitamin B12/folate deficiency are also associated with cognitive impairment and are not uncommon among older people. Early differentiation between AD and these conditions will inform practice and lead to correct and timely treatment for patients. The aim of this study is to assess the role of amyloid protein imaging using PET scans in confirming or excluding AD in patients with cognitive impairment.
Who can participate?
Adults aged 40 and over referred for memory problems.
What does the study involve?
All participants are given PET imaging scans to detect amyloid protein levels in the brain.
What are the possible benefits and risks of participating?
Not provided at time of registration.
Where is the study run from?
Sussex Partnership NHS Foundation Trust (UK)
When is the study starting and how long is it expected to run for?
May 2015 to February 2017
Who is funding the study?
1. Avid Radiopharmaceuticals, Inc. (USA)
2. Brighton and Sussex Medical School (UK)
Who is the main contact?
Dr N Tabet
Contact information
Scientific
Sussex Partnership NHS Foundation Trust
Cognitive Treatment and Research Unit
Grove House
Southview Close
Southview Close
TN6 1HB
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Non-randomised interventional diagnosis/screening study |
| Secondary study design | Non randomised study |
| Study type | Participant information sheet |
| Scientific title | Role of amyloid positron emission tomography (PET) imaging in the timely diagnosis of Alzheimer’s disease in patients with underlying depression or vitamin B12/Folate deficiency: feasibility study |
| Study objectives | Early differentiation between Alzheimer's disease (AD) and depression (with or without alcoholism) or vitamin B12/folate deficiency using amyloid PET imaging will inform practice and lead to correct and timely management of patients. |
| Ethics approval(s) | Multicentre Research Ethics Committee (MREC), 06/02/2015, ref: 14/LO/2276. |
| Health condition(s) or problem(s) studied | Alzheimer's disease |
| Intervention | Amyloid PET imaging to visualise in vivo presence of amyloid deposits in the brain. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
The primary outcome measure is to answer the question on whether the targeted use of the newly licensed amyloid PET imaging improves the diagnostic accuracy in patients presenting with cognitive impairment in addition to depression and/or vitamin B12 deficiency. This will be measured by calculating the number of patients whose diagnosis has changed post scan based on clinical decision. |
| Key secondary outcome measure(s) |
1. Clinician confidence levels in the diagnosis measured pre and post scan using personally administered Likert scales |
| Completion date | 01/02/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 10 |
| Key inclusion criteria | 1. Patients aged >40 referred to memory clinic 2. Presence of memory complaint suspicious of AD 3. Below normal scores on cognitive testing (CAMCOG, ACE III or sMMSE scores below the normal range) 4. Presence of specific co-morbid illnesses known to affect cognition and to complicate the diagnosis of Alzheimer’s disease, namely depression and vitamin B12 deficiency 5. MRI and/or CT brain scanning done previously as part of routine diagnostic process |
| Key exclusion criteria | 1. Evidence obtained from history, physical examination or investigations which clearly support the diagnosis of conditions such as vascular dementia, dementia with Lewy bodies and frontotemporal dementia 2. Lack of ability to give informed consent 3. Inability to undertake PET scanning or previous allergic reaction to injected investigative nuclear medicine tracers 4. Positive pregnancy test in premenopausal women and breastfeeding 5. Inability to undertake PET scanning |
| Date of first enrolment | 18/05/2015 |
| Date of final enrolment | 01/02/2017 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Grove House
Southview Road
Southview Road
TN6 1HB
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Abstract results | 01/07/2016 | 23/04/2021 | No | No | |
| HRA research summary | 28/06/2023 | No | No | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Poster results | 01/07/2016 | 23/04/2021 | No | No |
Editorial Notes
23/04/2021: Publication references added.
