Tricaprilin in Mild to Moderate Alzheimer's Disease

Completed · Phase 2 · Has a placebo group

Conditions studied: Alzheimer's Disease

In brief

The purpose of this study is to evaluate the safety, tolerability and effectiveness of tricaprilin administered once a day for ninety days in subjects with mild to moderate, probable Alzheimer's disease.

Key facts

Study ID

NCT00142805

Run by

Cerecin

People needed

152

Starts

2004-11-04

Expected to finish

2007-01-07

Last updated by the study team

2020-09-21

Who can join

Age: 50 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Informed Consent Form signed by patient and caregiver
• 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

You may not qualify if…

• Any condition that would, in the opinion of the Principal Investigator, render the patient or the caregiver unsuitable for the study, or place them at substantial risk of adverse outcome
• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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