CLEARLY - Janssen PACC ALZ0001 Study
Research type
Research Study
Full title
A Cross-sectional, Multinational, Noninterventional Study to Evaluate the Psychometric Comparability of Culturally Adapted Versions of the Global Preclinical Alzheimer’s Cognitive Composite (G-PACC)
IRAS ID
207365
Contact name
Fraser Inglis
Contact email
Sponsor organisation
Janssen-Cilag International N.V
Duration of Study in the UK
0 years, 9 months, 16 days
Research summary
The aim of this multinational study is to evaluate how similar translated forms of several study tests are to their original tests in English. This is a global study being conducted in 16 countries with 18 translations representing 10 languages. About 4275 people aged 60-85 in approximately 80 study centres will participate in the study. About half of the participants will have normal memory and thinking and half will have mild difficulty affecting only memory. Five sites will participate in UK and each site is targeted to enrol approximately 45 people. Participation in this study is expected to last 8 days. During this time, participants will take tests and questionnaires on 2 visits about one week apart administered by trained and certified Raters or Test Supervisors.
REC name
East Midlands - Derby Research Ethics Committee
REC reference
16/EM/0247
Date of REC Opinion
1 Jul 2016
REC opinion
Further Information Favourable Opinion