BP45085 Prescreening for Roche Alzheimer’s studies
Research type
Research Study
Full title
PRESCREENING STUDY FOR THE IDENTIFICATION OF POSSIBLE ELIGIBLE PARTICIPANTS FOR INTERVENTIONAL ALZHEIMER’S DISEASE ROCHE CLINICAL TRIALS
IRAS ID
338330
Contact name
Head, EU/ROW Regulatory Affairs Pharmaceutical Division
Contact email
Sponsor organisation
F Hoffmann-La Roche Ltd
Duration of Study in the UK
3 years, 8 months, 6 days
Research summary
The purpose of this prescreening study is to identify potential candidates for Roche interventional Alzheimer’s disease clinical trials.
Approximately 3000 participants will take part in this study
If a participant agrees to take part in the study, they will be asked to sign a informed consent form allowing the following evaluations to be completed:
• Recording of demographic information, any pre-existing medical conditions (including AD family history) and any medications
• Mini-Mental State Examination (MMSE): a simple questionnaire which will take approximately 10-15 minutes to complete, commonly used to check for general mental health of the study participant (i.e., cognitive impairments such as problems with thinking, communication, understanding and/or memory)
If the participant has a study companion (i.e., a family member or a caregiver) who will be able to accompany them to the clinic and who consents to take part in the study the following evaluation can be completed:
• Clinical Dementia Rating (CDR): detailed interview where the study participant and the study companion are asked about memory and daily activities of the study participant, which will take approx. 45 minutes to complete.
If the results of the pre-screening assessments show that participants might meet eligibility criteria for Roche interventional AD Clinical trials, the study doctor or related site personnel will detailed information on that study so they can decide whether or not to take part.
Some information and data collected in the pre-screening study might then be used within the settings of the Roche interventional AD clinical trial.Total time in the study will be 1-3 hours for participants and approx 1 hour for study companions. It will involve completing a small number of evaluations. Consent/assessments may be completed in clinic/hospital, at a mobile clinic or at the participant's home.
REC name
South West - Frenchay Research Ethics Committee
REC reference
24/SW/0059
Date of REC Opinion
20 May 2024
REC opinion
Unfavourable Opinion