Amyloid positron emission tomography (PET) imaging in the timely diagnosis of Alzheimer's disease

ISRCTN ISRCTN17685148
DOI https://doi.org/10.1186/ISRCTN17685148
Secondary identifying numbers 18884
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
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

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

Dr Naji Tabet
Scientific

Sussex Partnership NHS Foundation Trust
Cognitive Treatment and Research Unit
Grove House
Southview Close
Southview Close
TN6 1HB
United Kingdom

Study information

Study designNon-randomised interventional diagnosis/screening study
Primary study designInterventional
Secondary study designNon randomised study
Study setting(s)Hospital
Study typeDiagnostic
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleRole 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 objectivesEarly 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) studiedAlzheimer's disease
InterventionAmyloid PET imaging to visualise in vivo presence of amyloid deposits in the brain.
Intervention typeProcedure/Surgery
Primary outcome measureThe 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.
Secondary outcome measures1. Clinician confidence levels in the diagnosis measured pre and post scan using personally administered Likert scales
2. Distribution of amyloid in amyloid positive patients measured by amyloid PET imaging
Overall study start date18/05/2015
Completion date01/02/2017

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participantsUK Sample Size: 10
Key inclusion criteria1. 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 criteria1. 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 enrolment18/05/2015
Date of final enrolment01/02/2017

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Sussex Partnership NHS Foundation Trust
Cognitive Treatment and Research Unit
Grove House
Southview Road
Southview Road
TN6 1HB
United Kingdom

Sponsor information

Sussex Partnership NHS Foundation Trust
Hospital/treatment centre

Mill View Hospital
Sussex Education Centre
Nevill Avenue
Hove
BN3 7HY
England
United Kingdom

ROR logo "ROR" https://ror.org/05fmrjg27

Funders

Funder type

Other

Avid Radiopharmaceuticals, Inc. (USA)

No information available

Brighton and Sussex Medical School (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot expected to be made available
Publication and dissemination planThe results of this study will be presented at regional and national conferences. The results will also be published after data analysis in peer review journals.
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
Poster results 01/07/2016 23/04/2021 No No
HRA research summary 28/06/2023 No No

Editorial Notes

23/04/2021: Publication references added.