AC-1204 Long-term Efficacy Response Trial (ALERT Protocol)
| Status: | Completed |
|---|---|
| Conditions: | Alzheimer Disease |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 11/18/2012 |
| Start Date: | October 2011 |
| End Date: | October 2013 |
| Contact: | Samuel T Henderson, PhD |
| Email: | shenderson@accerapharma.com |
| Phone: | 303-999-3702 |
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 Alzheimer's Disease Who Are APOE4(-)
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).
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.
Inclusion Criteria:
- Males/females between age of 55 -85 years
- MMSE scores between 16-26
- Probable mild to moderate AD
Exclusion Criteria:
- Presence of other CNS disorders as alternative causes of dementia
- Type 1 or Type 2 diabetes
- Significant renal/hepatic disease
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