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

Withdrawn before enrolling · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Alzheimer's Disease

In brief

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).

Key facts

Study ID

NCT01211782

Run by

Cerecin

People needed

0

Last updated by the study team

2012-12-04

Who can join

Age: 55 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Males/females between age of 55 -85 years
• MMSE scores between 16-26
• Probable mild to moderate AD

You may not qualify if…

• Presence of other CNS disorders as alternative causes of dementia
• Type 1 or Type 2 diabetes
• Significant renal/hepatic disease

Where it is running

• Meridien Research — St. Petersburg, Florida, United States

Full record on ClinicalTrials.gov

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