Evaluation of Tau depositions with [18F]PI-2620 PET in aMCI and AD
Research type
Research Study
Full title
An Open Label, Single Center Study, to evaluate the Safety and Imaging Characteristics of [18F]PI-2620 as PET Radioligand for Imaging Tau deposition in the brains of subjects with amnestic mild cognitive impairment (aMCI) and mild to moderate Alzheimer’s disease (AD) in comparison with non-demented controls
IRAS ID
254854
Contact name
Marios Politis
Contact email
Sponsor organisation
Life Molecular Imaging GmbH
Eudract number
2018-003891-11
Duration of Study in the UK
1 years, 7 months, 31 days
Research summary
Alzheimer’s disease (AD) is a progressive neurodegenerative disorder and the main cause of dementia in the population over 65 years old. The number of people who will be affected by AD is expected to grow dramatically in the western countries, along with the increase in life expectancy.
Unfortunately, we do not know yet what causes AD. It is known that an abnormal aggregation of some proteins (called beta-amyloid and tau), is found in abnormal amounts in the brain of people who have died with AD. Indeed, AD is defined as a dementing disease with beta-amyloid plaques and tau tangles in the brain. However, we are still unaware about what mechanism underlies this process.
It is important, therefore, to understand whether, when, and how these proteins accumulate in patients with AD and to which extent.
Positron Emission Tomography (PET), is a non-invasive imaging technique that, with the aid of substances called tracers, allows to measure the quantity and the distribution of these proteins in vivo.
PET tracers for the detection of beta-amyloid are already available (such as [18F]Florbetaben) and are used in the clinical setting to understand if a patient with cognitive problems has AD. Three beta-amyloid tracers have been validated and are approved by the EMA and FDA. However, it has been recently understood that the amount of another substance called tau is associated with cognitive impairment in AD. This study aims to find a method to measure the amount of tau in the brain through a PET scan using a substance called [18F]PI-2620, which is a novel tracer able to detect the presence of tau-aggregate.
Our purpose in this study, therefore, is to perform PET scans with [18F]PI-2620 in non-demented healthy controls (baseline and 18-month follow-up scans) and in AD patients (mild and advanced), and in patients with amnestic Mild Cognitive Impairment (aMCI) at three different time points (baseline, 6-9-month and 17-20-month follow-up scans)to assess the amount of tau in the brain and how it accumulates over time.REC name
East of England - Cambridge South Research Ethics Committee
REC reference
19/EE/0021
Date of REC Opinion
11 Feb 2019
REC opinion
Unfavourable Opinion