Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
152 participants
INTERVENTIONAL
2004-11-04
2007-01-07
Brief Summary
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Detailed Description
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Participants will be randomized to receive either tricaprilin or a matching placebo, administered once a day by mixing powder in a glass of liquid. The treatment period will last 90 days, followed by a 2-week washout period. Each patient will be seen 5 times: at screening, baseline, and post-baseline days 45, 90, and 104. The visits will include physical and/or neuropsychological examinations, electrocardiograms (ECGs) and laboratory tests.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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AC-1202
Tricaprilin formulation, once daily. Administered orally
Tricaprilin
Powder formulation will be mixed in a liquid (approximately 8 oz).
Matching Placebo to AC-1202
Placebo formulation, once daily. Administered orally
Placebo
Powder formulation will be mixed in a liquid (approximately 8 oz).
Interventions
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Tricaprilin
Powder formulation will be mixed in a liquid (approximately 8 oz).
Placebo
Powder formulation will be mixed in a liquid (approximately 8 oz).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosis of probably Alzheimer's disease of mild to moderate severity
* Age 50 or older
* If female, 2 years postmenopausal or surgically sterile
* Hearing, vision, and physical abilities adequate to perform assessments (corrective aids allowed)
* Caregiver to attend all visits, perform assessments, and supervise administration of study medication
* CT or MRI within 24 months prior to screening compatible with a diagnosis of probably Alzheimer's disease
* Modified Hachinski Ischemia Scale score of 4 or less
* ADAS-Cog score between 15 and 35 inclusive at screening
* MMSE score between 14 and 24 inclusive at screening
* Stable medical condition for 3 consecutive months immediately prior to baseline
* No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening
Exclusion Criteria
* Unwillingness or inability of the patient and/or caregiver to fulfill the requirements of the study
* Resident in a skilled nursing facility
* Any significant neurological disease other than probable AD (e.g. Parkinson's disease, Huntington's disease, brain tumor, normal pressure hydrocephalus, progressive supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis, history of stroke, or history of head injury requiring hospitalization)
* An alternate cause for dementia other than AD as determined by a required CT or MRI scan within 24 months prior to screening
* Current history of major psychiatric disorder
* Major depression as determined by a Cornell Scale for Depression in Dementia
* Clinically significant hypothyroidism
* Clinically significant B12 deficiency
* Unstable or clinically significant cardiovascular disease
* Diabetes of any type
* History of tertiary syphilis
* Cancer within 3 years prior to baseline, with the exception of squamous and basal cell carcinoma
* Vital sign abnormalities
* Clinically significant renal disease or insufficiency
* Clinically significant hepatic disease or insufficiency
* Alcohol consumption greater than 2 oz of spirits per day or 14 oz per week (1 oz of spirits is equal to 6 oz of wine or 12 oz of beer)
* Current history of alcohol abuse or other substance abuse within 24 months prior to baseline
* Known HIV infection
* Use of any investigational compound within 30 days prior to screening
* Use of prohibited medications (contact site for details)
* Prior or current use of medium-chain triglycerides (MCTs) for medical purposes
* Known allergies to coconut oil
50 Years
90 Years
ALL
No
Sponsors
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Cerecin
INDUSTRY
Responsible Party
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Locations
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21st Century Neurology, a division of Xenoscience Inc.
Phoenix, Arizona, United States
Comprehensive NeuroScience
Cerritos, California, United States
Pharmacology Research Institute
Los Alamitos, California, United States
Pharmacology Research Institute
Newport Beach, California, United States
Pharmacology Research Institute
Northridge, California, United States
The Southwest Institute for Clinical Research
Rancho Mirage, California, United States
Pharmacology Research Institute
Riverside, California, United States
Baumel-Eisner Neuromedical Institute
Boca Raton, Florida, United States
Meridien Research
Brooksville, Florida, United States
Baumel-Eisner Neuromedical Institute, Inc.
Fort Lauderdale, Florida, United States
Sunrise Clinical Research
Hollywood, Florida, United States
Comprehensive NeuroScience
Melbourne, Florida, United States
Baumel-Eisner Neuromedical Institute
Miami Beach, Florida, United States
Anchor Research Center
Naples, Florida, United States
Renstar Medical Research
Ocala, Florida, United States
Comprehensive NeuroScience
St. Petersburg, Florida, United States
Meridien Research
St. Petersburg, Florida, United States
Meridien Research
Tampa, Florida, United States
Radiant Research
Chicago, Illinois, United States
Multi-Specialty Research Associates of North Carolina
Raleigh, North Carolina, United States
Radiant Research
Portland, Oregon, United States
Radiant Research
Dallas, Texas, United States
Research Across America
Dallas, Texas, United States
Radiant Research
San Antonio, Texas, United States
Grayline Clinical Drug Trials
Wichita Falls, Texas, United States
Countries
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References
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Blass JP, Zemcov A. Alzheimer's disease. A metabolic systems degeneration? Neurochem Pathol. 1984 Summer;2(2):103-14. doi: 10.1007/BF02834249.
Reiman EM, Caselli RJ, Yun LS, Chen K, Bandy D, Minoshima S, Thibodeau SN, Osborne D. Preclinical evidence of Alzheimer's disease in persons homozygous for the epsilon 4 allele for apolipoprotein E. N Engl J Med. 1996 Mar 21;334(12):752-8. doi: 10.1056/NEJM199603213341202.
Small GW, Ercoli LM, Silverman DH, Huang SC, Komo S, Bookheimer SY, Lavretsky H, Miller K, Siddarth P, Rasgon NL, Mazziotta JC, Saxena S, Wu HM, Mega MS, Cummings JL, Saunders AM, Pericak-Vance MA, Roses AD, Barrio JR, Phelps ME. Cerebral metabolic and cognitive decline in persons at genetic risk for Alzheimer's disease. Proc Natl Acad Sci U S A. 2000 May 23;97(11):6037-42. doi: 10.1073/pnas.090106797.
Swaab DF, Lucassen PJ, Salehi A, Scherder EJ, van Someren EJ, Verwer RW. Reduced neuronal activity and reactivation in Alzheimer's disease. Prog Brain Res. 1998;117:343-77. doi: 10.1016/s0079-6123(08)64027-3.
Laffel L. Ketone bodies: a review of physiology, pathophysiology and application of monitoring to diabetes. Diabetes Metab Res Rev. 1999 Nov-Dec;15(6):412-26. doi: 10.1002/(sici)1520-7560(199911/12)15:63.0.co;2-8.
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. doi: 10.1073/pnas.97.10.5440.
Henderson ST, Poirier J. Pharmacogenetic analysis of the effects of polymorphisms in APOE, IDE and IL1B on a ketone body based therapeutic on cognition in mild to moderate Alzheimer's disease; a randomized, double-blind, placebo-controlled study. BMC Med Genet. 2011 Oct 12;12:137. doi: 10.1186/1471-2350-12-137.
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. doi: 10.1186/1743-7075-6-31.
Related Links
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Accera Pharmaceuticals Clinical Trials Query Form
Other Identifiers
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KET-04-001
Identifier Type: -
Identifier Source: org_study_id
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