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

Cerecin

Status and phase: Withdrawn; Phase 3; Phase 2

Conditions: Alzheimer's Disease

Treatments: Drug: caprylic triglyceride; Drug: long-chain triglyceride

Study type: Interventional

Funder types: Industry

Identifiers

NCT01211782

AC-10-006

Details and patient eligibility

About

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).

Full 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.

Sex: All

Ages: 55 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 2 patient groups, including a placebo group

AC-1204

Experimental group

Treatment:

Drug: caprylic triglyceride

Placebo

Placebo Comparator group

Treatment:

Drug: long-chain triglyceride