Condition category
Mental and Behavioural Disorders
Date applied
20/05/2015
Date assigned
20/05/2015
Last edited
25/08/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Naji Tabet

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

18884

Study information

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

Acronym

Study hypothesis

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

Multicentre Research Ethics Committee (MREC), 06/02/2015, ref: 14/LO/2276.

Study design

Non-randomised interventional diagnosis/screening study

Primary study design

Interventional

Secondary study design

Non randomised 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

Alzheimer's disease

Intervention

Amyloid PET imaging to visualise in vivo presence of amyloid deposits in the brain.

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measures

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.

Secondary outcome measures

1. 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 trial start date

18/05/2015

Overall trial end date

01/02/2017

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

UK Sample Size: 10

Participant 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

Recruitment start date

18/05/2015

Recruitment end date

01/02/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

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

Sponsor information

Organisation

Sussex Partnership NHS Foundation Trust

Sponsor details

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

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Other

Funder name

Avid Radiopharmaceuticals, Inc. (USA)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Brighton and Sussex Medical School (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The 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.

Intention to publish date

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes