The CHARIOT:PRO Study Protocol REGISTRYALZ0001
Research type
Research Study
Full title
The Cognitive Health in Ageing Register: Investigational, Observational, and Trial studies in dementia research (CHARIOT): Prospective Readiness cOhort Study (PRO)
IRAS ID
140764
Contact name
Chinedu Udeh-Momoh
Contact email
Sponsor organisation
Janssen R&D, LLC
Clinicaltrials.gov Identifier
Duration of Study in the UK
5 years, 10 months, 31 days
Research summary
It has been established that pathological changes in the brain of Alzheimer’s Disease (AD) patients occur many years prior to disease onset. Clinically, the lengthy “prodromal” phase may involve subtle cognitive and memory symptoms, followed by the phase of Mild Cognitive Impairment (MCI) prior to the established disease. Although the prodromal phase may remain undetected, this is the stage where drug intervention may be most successful. Hence the need to identify more reliable methods to detect the subtle cognitive changes that occur prior to a diagnosis of MCI or AD dementia and further our understanding of the disease aetiology and progression. Earlier identification of those at risk may allow for earlier intervention and greater impact on prognosis. This study may further shed light on which assessments are most sensitive in detecting cognitive changes in the earliest clinical AD stages.
Study design: The CHARIOT: PRO Study is a single-centre prospective cohort study of approximately 700 participants that will have self-referred or will have been recruited from the CHARIOT register. Over the course of the study each participant will undertake multiple neuropsychological tests, as well as completing self-report questionnaires assessing mood and lifestyle factors every six months; biological samples (blood, urine, saliva, DNA) will also be collected annually over a four year period. With the addition of the CHARIOT-PRO substudy, up to a further 500 participants without signs of cognitive impairment will be recruited. The sub study participants will undergo the same, and additional assessments, but will do so every three months over a three and a half year period. Aβ42 is a marker of elevated risk of AD. Approximately half of these participants will have evidence of amyloid-beta (Aβ42) protein pathology determined from either low Cerebrospinal Fluid (CSF) Aβ42 concentration or a PET scan showing detectable deposition of Aβ42.
REC name
London - Central Research Ethics Committee
REC reference
15/LO/0711
Date of REC Opinion
12 Jun 2015
REC opinion
Further Information Favourable Opinion