Tricaprilin in Mild to Moderate Alzheimer's Disease
Safety, Tolerability and Efficacy Study of Tricaprilin (AC-1202) Administered for Ninety Days in Subjects With Probable Alzheimer's Disease of Mild to Moderate Severity
1 other identifier
interventional
152
1 country
25
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2004
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 4, 2004
CompletedFirst Submitted
Initial submission to the registry
September 1, 2005
CompletedFirst Posted
Study publicly available on registry
September 2, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 29, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
January 7, 2007
CompletedSeptember 21, 2020
September 1, 2020
1.6 years
September 1, 2005
September 18, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of subjects with treatment related adverse events
AE incidence rate per treatment group
104 days
Secondary Outcomes (4)
Pharmacokinetics (PK) profile of tricaprilin
Baseline, Day 45, Day 90
Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog)
90 days
Clinical Global Impression of Change
90 days
Mini-Mental State Exam (MMSE)
90 days
Study Arms (2)
AC-1202
ACTIVE COMPARATORTricaprilin formulation, once daily. Administered orally
Matching Placebo to AC-1202
PLACEBO COMPARATORPlacebo formulation, once daily. Administered orally
Interventions
Powder formulation will be mixed in a liquid (approximately 8 oz).
Powder formulation will be mixed in a liquid (approximately 8 oz).
Eligibility Criteria
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
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cerecinlead
Study Sites (25)
21st Century Neurology, a division of Xenoscience Inc.
Phoenix, Arizona, 85013, United States
Comprehensive NeuroScience
Cerritos, California, 90703, United States
Pharmacology Research Institute
Los Alamitos, California, 90720, United States
Pharmacology Research Institute
Newport Beach, California, 92660, United States
Pharmacology Research Institute
Northridge, California, 91324, United States
The Southwest Institute for Clinical Research
Rancho Mirage, California, 92270, United States
Pharmacology Research Institute
Riverside, California, 92506, United States
Baumel-Eisner Neuromedical Institute
Boca Raton, Florida, 33486, United States
Meridien Research
Brooksville, Florida, 34613, United States
Baumel-Eisner Neuromedical Institute, Inc.
Fort Lauderdale, Florida, 33321, United States
Sunrise Clinical Research
Hollywood, Florida, 33021, United States
Comprehensive NeuroScience
Melbourne, Florida, 32935, United States
Baumel-Eisner Neuromedical Institute
Miami Beach, Florida, 33154, United States
Anchor Research Center
Naples, Florida, 34102, United States
Renstar Medical Research
Ocala, Florida, 34471, United States
Comprehensive NeuroScience
St. Petersburg, Florida, 33702, United States
Meridien Research
St. Petersburg, Florida, 33709, United States
Meridien Research
Tampa, Florida, 33609, United States
Radiant Research
Chicago, Illinois, 60610, United States
Multi-Specialty Research Associates of North Carolina
Raleigh, North Carolina, 27609, United States
Radiant Research
Portland, Oregon, 97239, United States
Radiant Research
Dallas, Texas, 75231, United States
Research Across America
Dallas, Texas, 75234, United States
Radiant Research
San Antonio, Texas, 78229, United States
Grayline Clinical Drug Trials
Wichita Falls, Texas, 76309, United States
Related Publications (8)
Blass JP, Zemcov A. Alzheimer's disease. A metabolic systems degeneration? Neurochem Pathol. 1984 Summer;2(2):103-14. doi: 10.1007/BF02834249.
PMID: 6544385BACKGROUNDReiman 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.
PMID: 8592548BACKGROUNDSmall 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.
PMID: 10811879BACKGROUNDSwaab 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.
PMID: 9932420BACKGROUNDLaffel 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.
PMID: 10634967BACKGROUNDKashiwaya 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.
PMID: 10805800BACKGROUNDHenderson 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.
PMID: 21992747DERIVEDHenderson 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.
PMID: 19664276DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 1, 2005
First Posted
September 2, 2005
Study Start
November 4, 2004
Primary Completion
June 29, 2006
Study Completion
January 7, 2007
Last Updated
September 21, 2020
Record last verified: 2020-09