Therapeutics

AC-1204

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Overview

Name: AC-1204
Synonyms: Caprylic triglyceride, Long-chain triglycerides
Therapy Type: Dietary Supplement (timeline)
Target Type: Other (timeline)
Condition(s): Alzheimer's Disease
U.S. FDA Status: Alzheimer's Disease (Phase 2/3)
Company: Accera, Inc.
Approved for: None

Background

AC-1204 is the follow-up formulation to Accera's AC-1202 medical food product. AC-1204 is designed to induce chronic ketosis in order to improve mitochondrial metabolism. Regional reductions in cerebral glucose utilization are an early feature of Alzheimer's disease (Reiman et al., 2004). The rationale behind AC-1204 is to boost cellular metabolism in Alzheimer's by providing a fuel alternative to glucose. Caprylic acid is metabolized into so-called ketone bodies, such as acetoacetic acid and β-hydroxybutyric acid, which can be converted to acetyl-CoA to produce energy via the citric acid cycle.

Findings

Based on clinical experience with Accera's Axona, a medical food similar to AC-1204, this new formulation entered clinical evaluation in Phase 2/3.

In December 2012, Accera withdrew ALERT, a planned six-month Phase 2/3 trial it had previously registered (NCT01211782), reportedly because it was being redesigned. 

In March 2013, Accera instead began NOURISH AD, a multicenter, six-month efficacy trial with an optional six-month, open-label extension. This trial has begun enrolling 480 patients with mild to moderate AD. It will compare as its primary outcome the effect of daily administration of AC-1204 to placebo on the Alzheimer's Disease Assessment Scale—Cognitive Subscale (ADAS—Cog) in ApoE4 non-carriers. In addition, the trial is designed to compare a number of secondary outcome measures in ApoE4 carriers and non-carriers. 

For all clinical trials on AC-1204, see clinicaltrials.gov.

Clinical Trial Timeline

  • Phase 2/3
  • Study completed / Planned end date
  • Planned end date unavailable
  • Study aborted
Sponsor Clinical Trial 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
Accera, Inc. NCT01741194
N=480

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References

Therapeutics Citations

  1. Ketasyn

Paper Citations

  1. . Functional brain abnormalities in young adults at genetic risk for late-onset Alzheimer's dementia. Proc Natl Acad Sci U S A. 2004 Jan 6;101(1):284-9. PubMed.

External Citations

  1. clinicaltrials.gov

Further Reading

No Available Further Reading