Tricaprilin in Mild to Moderate Alzheimer's Disease

Cerecin

Status and phase

Completed

Phase 2

Conditions

Alzheimer's Disease

Treatments

Drug: Tricaprilin

Other: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00142805

KET-04-001

Details and patient eligibility

About

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.

Full description

Substantial scientific evidence has shown that defects in glucose metabolism occur in Alzheimer's disease. Attempts to compensate for the reduced cerebral metabolic rates in AD have met with some success. Treatment of AD patients with high doses of glucose and insulin will raise cognitive scores. However, this effect is slight, and high doses of insulin can have adverse consequences. Administration of ketone bodies or their metabolic precursors such as medium chain triglycerides (MCTs) presents an attractive alternative to glucose and insulin. In a preliminary study, tricaprilin, an MCT, demonstrated pharmacological activity and statistically significant efficacy in improving short-term memory and attention performance after a single dose.

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.

Enrollment

152 patients

Sex

All

Ages

50 to 90 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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