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Sponsored by: |
Accera, Inc. |
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Information provided by: | National Institute on Aging (NIA) |
ClinicalTrials.gov Identifier: | NCT00142805 |
The purpose of this study is to evaluate the safety, tolerability and effectiveness of Ketasyn™ administered once a day for ninety days in subjects with mild to moderate, probable Alzheimer's disease.
Condition | Intervention | Phase |
---|---|---|
Alzheimer's Disease |
Drug: Ketasyn™ (AC-1202) |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Safety, Tolerability and Efficacy Study of Ketasyn™ (AC-1202) Administered for Ninety Days in Subjects With Probable Alzheimer's Disease of Mild to Moderate Severity |
Estimated Enrollment: | 100 |
Study Start Date: | October 2004 |
Estimated Study Completion Date: | March 2006 |
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, Ketasyn™, 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 Ketasyn™ 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.
Ages Eligible for Study: | 50 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Arizona | |
21st Century Neurology, a division of Xenoscience Inc. | |
Phoenix, Arizona, United States, 85013 | |
United States, California | |
Comprehensive NeuroScience | |
Cerritos, California, United States, 90703 | |
The Southwest Institute for Clinical Research | |
Rancho Mirage, California, United States, 92270 | |
Pharmacology Research Institute | |
Riverside, California, United States, 92506 | |
Pharmacology Research Institute | |
Los Alamitos, California, United States, 90720 | |
Pharmacology Research Institute | |
Northridge, California, United States, 91324 | |
Pharmacology Research Institute | |
Newport Beach, California, United States, 92660 | |
United States, Florida | |
Meridien Research | |
Tampa, Florida, United States, 33609 | |
Meridien Research | |
St. Petersburg, Florida, United States, 33709 | |
Meridien Research | |
Brooksville, Florida, United States, 34613 | |
Comprehensive NeuroScience | |
St. Petersburg, Florida, United States, 33702 | |
Comprehensive NeuroScience | |
Melbourne, Florida, United States, 32935 | |
Baumel-Eisner Neuromedical Institute, Inc. | |
Ft. Lauderdale, Florida, United States, 33321 | |
Baumel-Eisner Neuromedical Institute | |
Miami Beach, Florida, United States, 33154 | |
Baumel-Eisner Neuromedical Institute | |
Boca Raton, Florida, United States, 33486 | |
Renstar Medical Research | |
Ocala, Florida, United States, 34471 | |
Sunrise Clinical Research | |
Hollywood, Florida, United States, 33021 | |
Anchor Research Center | |
Naples, Florida, United States, 34102 | |
United States, Illinois | |
Radiant Research | |
Chicago, Illinois, United States, 60610 | |
United States, North Carolina | |
Multi-Specialty Research Associates of North Carolina | |
Raleigh, North Carolina, United States, 27609 | |
United States, Oregon | |
Radiant Research | |
Portland, Oregon, United States, 97239 | |
United States, Texas | |
Radiant Research | |
Dallas, Texas, United States, 75231 | |
Radiant Research | |
San Antonio, Texas, United States, 78229 | |
Grayline Clinical Drug Trials | |
Wichita Falls, Texas, United States, 76309 | |
Research Across America | |
Dallas, Texas, United States, 75234 |
Study Director: | Sam Henderson, PhD | Accera, Inc. |
Study ID Numbers: | IA0076 |
Study First Received: | September 1, 2005 |
Last Updated: | December 30, 2008 |
ClinicalTrials.gov Identifier: | NCT00142805 |
Health Authority: | United States: Institutional Review Board; United States: Federal Government |
ketones Apolipoprotein E ApoE genotype cognitive function glucose metabolism |
Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Alzheimer Disease Central Nervous System Diseases Neurodegenerative Diseases |
Brain Diseases Dementia Cognition Disorders Delirium |
Nervous System Diseases Tauopathies |