PUSKAS V1.0
Research type
Research Study
Full title
Punch Biopsy for Skin α-Synuclein in Dementia with Lewy Bodies(PuSkAS). A Pilot and Feasibility Study.
IRAS ID
195054
Contact name
Alan Thomas
Contact email
Sponsor organisation
Newcsatle upon Tyne Hospitals NHS Foundation Trust
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
Dementia with Lewy bodies (DLB) is the second most common type of degenerative dementia following Alzheimer’s disease (AD). It is closely related to Parkinsons’ disease (PD). It accounts for at least 4.2% of all dementia diagnosed in the community.
It is important to differentiate DLB from other types of dementia because specific types of drugs called antipsychotics can be very harmful in DLB. However, DLB can be difficult to diagnose, with only 30% of cases being identified in many centres. Often more than 10 clinic visits are needed before a correct diagnosis is made. A test that is able to differentiate between DLB and other types of dementia may help to improve rates of diagnosis.
α-Synuclein (αSyn) is a protein found in the brain and other parts of the nervous system of people with DLB and PD. Recent studies using a simple and safe technique called a punch biopsy have found that αSyn can be identified in the skin (cutaneous) nerves of people with Parkinson’s disease (PD).
In this pilot study we will recruit 10 people with DLB, 10 with PD and 10 healthy older people. Each will have two punch biopsies along with a clinical assessment. The punch biopsy removes a cylindrical sample of skin that is 3mm in diameter (less than half a centimetre wide). Following two biopsies, volunteers will have the option of another two biopsies in the same areas on the opposite site of the body.
This pilot study aims to confirm that we can identify αSyn in the skin nerves of people with PD and DLB. If this is the case, and healthy older people do not have αSyn in their cutaneous nerves then it may be a useful diagnostic test for DLB.
REC name
North East - Newcastle & North Tyneside 1 Research Ethics Committee
REC reference
16/NE/0359
Date of REC Opinion
12 Dec 2016
REC opinion
Further Information Favourable Opinion