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

Not Applicable

Completed

• Conditions: Alzheimer's disease; Mental and Behavioural Disorders; Dementia in Alzheimer disease

• Registration Number: ISRCTN17685148
• Lead Sponsor: Sussex Partnership NHS Foundation Trust

Brief Summary

2016 poster in https://doi.org/10.1016/j.jalz.2016.06.031 (added 23/04/2021) (published 01/07/2016) 2016 abstract in https://doi.org/10.1016/j.jalz.2016.06.1890 (added 23/04/2021) (published 01/07/2016)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-05-20
• Study Completion: 2017-02-01
• Last Update Posted: 3 May 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 10

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
<br> 1. Clinician confidence levels in the diagnosis measured pre and post scan using personally administered Likert scales<br> 2. Distribution of amyloid in amyloid positive patients measured by amyloid PET imaging<br>