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Home: Drug Development: Drugs in Clinical Trials
Drugs In Clinical Trials

Important Notice: The Forum does not endorse any medical product or therapy. ALL medications and supplements should be taken ONLY under the supervision of a physician, due to the possibility of side-effects, drug interactions, etc.

Name: AC-1204
Other Names: caprylic triglyceride, long-chain triglyceride
Therapeutic Applications: Mild to moderate Alzheimer Disease
Therapy Types: Medical food
Mechanisms: Chronic induction of ketosis to improve mitochondrial metabolism
Development Status: investigational in U.S.
FDA Phase: Phase II/III
Primary Medical Role: AC-1204 is a ketogenic compound administered as a medical food. Ketosis induces the production of ketone bodies, predominantly beta-hydroxybutyrate (BHB) that substitutes for glucose as an energy substrate for the production of ATP.
Role in Alzheimer's Disease: AC-1204 increases ketone body production and targets glucose hypometabolism by providing increased ketone bodies as an alternative energy source in the brain. Accera's Ketasyn (AC-1202) was FDA approved as a medical food in 2009. See related Alzforum News article Medical Foods—Fallback Option for Elusive AD Drug Status?. Results of clinical testing of AC-1202 was published by Henderson et al 2009. In vitro data shows that ketone body beta-hydroxybutyrate (BHB) preserves neuronal integrity and stability (Izumi et al 1998). BHB has been shown to reduce the total Abeta40 and Abeta42 and reduces Abeta toxicity (Kashiwaya et al 2000; Van der Auwera et al 2005).
Companies: Accera, Inc.
Notes: Accera has announced a Phase II/III clinical trial to test long-term efficacy response of AC-1204 in subjects with mild to moderate Alzheimer's Disease who are APOE4(-). This study is not yet open for participant recruitment. See NCT01211782 for further details.

This entry was updated November 29, 2010.


References

Henderson ST, Vogel JL, Barr LJ, Garvin F, Jones JJ, Costantini LC. Study of the ketogenic agent AC-1202 in mild to moderate Alzheimer's disease: a randomized, double-blind, placebo-controlled, multicenter trial. Nutr Metab (Lond). 2009 Aug 10;6:31. POW link

Van der Auwera I, Wera S, Van Leuven F, Henderson ST. A ketogenic diet reduces amyloid beta 40 and 42 in a mouse model of Alzheimer's disease. Nutr Metab (Lond). 2005 Oct 17;2:28. POW link

Kashiwaya Y, Takeshima T, Mori N, Nakashima K, Clarke K, Veech RL. D-beta-hydroxybutyrate protects neurons in models of Alzheimer's and Parkinson's disease. Proc Natl Acad Sci U S A. 2000 May 9;97(10):5440-4. POW link

Izumi Y, Ishii K, Katsuki H, Benz AM, Zorumski CF. beta-Hydroxybutyrate fuels synaptic function during development. Histological and physiological evidence in rat hippocampal slices. J Clin Invest. 1998 Mar 1;101(5):1121-32. POW link


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