AC-1204 Long-term Efficacy Response Trial (ALERT Protocol)

• Status: Withdrawn
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Accera, Inc.; Cerecin

Criteria

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