Synonyms: Caprylic triglyceride, Long-chain triglycerides
Therapy Type: Dietary Supplement
Target Type: Other
Condition(s): Alzheimer's Disease
U.S. FDA Status: Alzheimer's Disease (Phase 2/3)
Company: Accera, Inc.
Approved for: None
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.
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 enrolliing 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
- Reiman EM, Chen K, Alexander GE, Caselli RJ, Bandy D, Osborne D, Saunders AM, Hardy J. 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.
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