TNF inhibitors in the prevention of Alzheimer’s disease

Study ID: 40861
Short Title: RESIST(TNF) - RhEumatoid arthritiS, medIcation and memory STudy
Organisation: University Hospital Southampton NHS Foundation Trust
Location: Southampton General Hospital
Condition: Parkinson's disease
Main Specialty: Neurological disorders
Expected End Date: 29/05/2020
Postcode: SO16 6YD
Contact Name: R&D department
Contact Email: R&
Active: Yes

Inclusion Criteria

• Participant is willing and able to give informed consent for participation in the study. • Participant is willing and able to participate for the 18 month study or until the participant develops dementia • Diagnosis of RA as per EULAR/ACR criteria • For TNFi arm of study: on a TNFi (Etanercept, Adalimumab, Certolizumab pegol, Golimumab, Infliximab). May also be on a sDMARD in conjunction. • For sDMARD arm of study: on a traditional synthetic DMARD (Methotrexate, Azathioprine, Lefunomide, Ciclosporin, Cyclophosphamide) • MCI participants: Clinical diagnosis of aMCI in keeping with accepted Petersen criteria (27) • Fluent in the English language

Exclusion Criteria

• Participants not able to provide consent. • Participant not able to carry out cognitive tests due to visual/hearing impairment • Participant not willing for follow-up • Loss of capacity to provide informed consent during the study • Unlikely to cooperate in the study, not be able to be present at all scheduled visits or not be able to follow study instructions • Participation in another research study with administration of any investigational drug at time of enrolment • Any previous or current medical condition that may impact on cognitive performance left to the Principal Investigator’s judgement • Participants taking cholinesterase inhibitor medication or memantine

Study summary:

TNF-α inhibitors (TNFi) are widely used in the treatment of rheumatoid arthritis (RA), a chronic inflammatory arthritis. They are usually prescribed when traditional disease modifying antirheumatic drugs (DMARDs) such as methotrexate do not work. There is a compelling and strengthening evidence base relating to the use of TNFi in cognitive protection. Longitudinal prospective studies are lacking, however, and much of the evidence to date does not control for other factors which have an impact such as age, gender, severity of rheumatoid disease etc. We wish to carry out a comprehensive longitudinal study of RA patients on TNFi who have mild cognitive impairment with a memory deficit (aMCI) and follow their cognition over 18 months. We will compare this group to a group of RA patients with aMCI who are on traditional DMARDs. Participants will be recruited from rheumatology day centres in Belfast, Antrim and Southampton. Screening cognitive tests will be carried out at baseline and every 6 months until the study end. We will compare cognitive decline in both groups using statistical methods. If TNFi are found to reduce the rate of cognitive decline in participants with RA who have aMCI this will add to the evidence base and would give enough evidence for a definitive randomised controlled trial of TNFi in MCI or people at risk of dementia.

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