Ignite Creation Date:
2024-05-11 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06402838
Status:
RECRUITING
Last Update Posted:
2024-07-01
First Post:
2024-05-03
Brief Title:
A Study to Evaluate the Safety and Biomarker Effects of RO7269162 in Participants at Risk for or at the Prodromal Stage of Alzheimers Disease AD
Sponsor:
Hoffmann-La Roche
Organization:
Hoffmann-La Roche
Study Overview
Official Title:
A Phase IIa Randomized Double-Blind Placebo-Controlled Multiple Dose Multicenter Parallel-Group Study to Investigate the Safety Tolerability and the Effect of RO7269162 on Amyloid and Non-Amyloid Disease-Related Biomarkers Following Daily Oral Administration in Participants at Risk for or at the Prodromal Stage of Alzheimers Disease
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This clinical trial is recruiting people who either are at risk of AD - have build-up of beta-amyloid but have no clinical symptoms or with a diagnosis of mild cognitive impairment People can take part if they have a certain level of plaques beta-amyloid in the brain shown by a positron emission tomography PET scan a medical imaging technique in which tracers are injected to visualize specific pathological processes in the brain People who take part in this clinical trial participants will be given RO7269162 OR placebo for up to about 1 and a half years The clinical trial team will see them every 3 weeks in the first 3 months and then every 6 weeks until the end of the trial These hospital visits will include checks to see how the participant responds to the treatment and any side effects they may have The total time of participation in the clinical trial will be 90 weeks
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None