Ignite Creation Date:
2024-05-06 @ 3:15 AM
Last Modification Date:
2024-10-26 @ 11:30 AM
Study NCT ID:
NCT02245737
Status:
TERMINATED
Last Update Posted:
2019-12-03
First Post:
2014-09-18
Brief Title:
An Efficacy and Safety Study of Lanabecestat LY3314814 in Early Alzheimers Disease
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
Official Title:
A 24-month Multicenter Randomized Double-blind Placebo-controlled Parallel-group Efficacy Safety Tolerability Biomarker and Pharmacokinetic Study of AZD3293 in Early Alzheimers Disease The AMARANTH Study
Status:
TERMINATED
Status Verified Date:
2019-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
An independent assessment concluded the trial was not likely to meet the primary endpoint upon completion and therefore trial stopped for futility
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AMARANTH
Brief Summary:
The purpose of this study is to assess the efficacy and safety of lanabecestat compared with placebo administered for 104 weeks in the treatment of early Alzheimers disease The study will test the hypothesis that lanabecestat is a disease-modifying treatment for participants with early Alzheimers disease defined as the continuum of participants with mild cognitive impairment MCI due to Alzheimers disease and participants diagnosed with mild dementia of the Alzheimers type as measured by change from baseline on the 13-item Alzheimers Disease Assessment Scale - Cognitive Subscale ADAS-Cog13 score at week 104 in each of the 2 lanabecestat treatment groups compared with placebo
Detailed Description:
Participants who meet other study entry requirements will be required to undergo either an amyloid positron emission tomography PET scan or a lumbar puncture for cerebrospinal fluid CSF sampling at screening to document presence of abnormal levels of brain and CSF amyloid for study inclusion The study includes 2 sub-studies the participants that undergo a PET scan at screening will be included in the PET-substudy and participants who undergo a lumbar puncture at screening will be included in the CSF substudy until each of these substudies are completed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| I8D-MC-AZES | OTHER | None | None |
| 2014-002601-38 | EUDRACT_NUMBER | None | None |
| D5010C00009 | OTHER | AstraZeneca | None |