Ignite Creation Date:
2024-05-05 @ 10:56 PM
Last Modification Date:
2024-10-26 @ 10:25 AM
Study NCT ID:
NCT01211782
Status:
WITHDRAWN
Last Update Posted:
2012-12-04
First Post:
2010-09-24
Brief Title:
AC-1204 Long-term Efficacy Response Trial ALERT Protocol
Sponsor:
Cerecin
Organization:
Cerecin
Study Overview
Official Title:
A Phase 2-3 6-12 Month Double-blind Randomized Placebo-controlled Parallel-group Study to Investigate the Effects of Daily Administration of AC-1204 in Subjects With Mild to Moderate Alzheimers Disease Who Are APOE4-
Status:
WITHDRAWN
Status Verified Date:
2012-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study never started Study was redesgined
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ALERT
Brief Summary:
The study will evaluate the safety efficacy of AC-1204 a ketogenic compound administered orally on a daily basis for 6 months Following the 6 month double-blind phase of the study subjects may enroll in an optional 6 month open-label extension phase Efficacy will be evaluated by standard tests of memory and cognition along with other measurements of activities of daily living and quality of life Safety will be assessed by frequency of adverse events and changes in laboratory test results Subjects will be stratified and outcomes will be separately analyzed based on apolipoprotein E4 genotype APOE4
Detailed Description:
Two primary outcome measures will be assessed in APOE4- patients
1 differences from baseline between AC-1204 and placebo groups ADAS-cog scores at 6 months
2 differences from baseline between AC-1204 and placebo groups CIBIC scores at 6 months Secondary endpoints will include differences between AC-1204 placebo groups scores for these same instruments at 3 months
1 differences from baseline between AC-1204 and placebo groups ADAS-cog scores at 6 months
2 differences from baseline between AC-1204 and placebo groups CIBIC scores at 6 months Secondary endpoints will include differences between AC-1204 placebo groups scores for these same instruments at 3 months
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