SUPErB version 1.0
Research type
Research Study
Full title
123I-MIGB Scintigraphy Utility as a biomarker for Prodromal DEmentia with Lewy Bodies (SUPErB)
IRAS ID
188206
Contact name
Aaron Jackson
Contact email
Sponsor organisation
Newcastle upon Tyne Hospitals NHS Foundation Trust
Duration of Study in the UK
7 years, 0 months, 1 days
Research summary
Dementia with Lewy Bodies (DLB) is the second commonest cause of dementia in the UK. If we are to manage the disease effectively and maximise the future use of disease-modifying treatments, we must establish accurate diagnoses at a much earlier stage in the disease process, during the prodromal or pre-dementia phases of the disease. Currently there are no validated, diagnostic criteria for prodromal DLB but biomarkers have been shown to facilitate the early and accurate diagnosis of DLB.
There are four modalities of imaging biomarkers:(1) MRI: Can be used to measure the volume of tissue damage, specifically of the hippocampal region (part of the brain associated with memory).
(2) Amyloid PET: The presence or absence of amyloid in the brain may be useful in terms of assessing the prognosis of DLB and thus a tool for selecting patients for amyloid therapeutics should they become available in the future.
(3) FP-CIT SPECT: Look at changes in the levels of dopamine (a neuro-transmitter essential for healthy brain functioning) and serial FP-CIT imaging can look at progressive changes over time.
(4) 123I-MIBG: This is known as imaging of the heart or Myocardial Scintigraphy (MIBG). It focuses on the nerves which project from the brain towards the heart and can detect damage to those nerves (synuclein pathology).
Although FP-CIT findings are encouraging, MIBG is likely to prove a better earlier biomarker because cardiac synuclein pathology occurs very early on in the disease process. Both imagining techniques have good diagnostic accuracy in established DLB and are already available in the NHS.
Other related biological abnormalities worthy of further investigation focus on the autonomic nervous system and include using an autonomic symptom scale (known as COMPASS), assessment of heart rate variability (HRV), assessment of brain wave activity (EEG) and assessment of cardiac function (ECG).
REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
15/NE/0420
Date of REC Opinion
19 Jan 2016
REC opinion
Further Information Favourable Opinion