Ketasyn in Mild to Moderate Alzheimer's Disease

This study has been completed.
Sponsor:
Information provided by:
National Institute on Aging (NIA)
ClinicalTrials.gov Identifier:
NCT00142805
First received: September 1, 2005
Last updated: December 30, 2008
Last verified: September 2006
  Purpose

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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by National Institute on Aging (NIA):

Primary Outcome Measures:
  • Changes measured by Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) at all 5 visits
  • Alzheimer's Disease Cooperative Study - Clinician's Global Impression of Change (ADCS-CGIC) at visits 2 through 5
  • Mini-Mental State Exam (MMSE) at all 5 visits

Secondary Outcome Measures:
  • Changes measured by Electrocardiogram (ECG) at visits 1 and 5
  • Beta-Hydroxybutyrate pre-dose levels at all 5 visits
  • Beta-Hydroxybutyrate 2-hour post-dose levels at visits 2, 3, and 4

Estimated Enrollment: 100
Study Start Date: October 2004
Estimated Study Completion Date: March 2006
Detailed 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, 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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00142805

Locations
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
Pharmacology Research Institute
Los Alamitos, California, United States, 90720
Pharmacology Research Institute
Newport Beach, California, United States, 92660
Pharmacology Research Institute
Northridge, California, United States, 91324
The Southwest Institute for Clinical Research
Rancho Mirage, California, United States, 92270
Pharmacology Research Institute
Riverside, California, United States, 92506
United States, Florida
Baumel-Eisner Neuromedical Institute
Boca Raton, Florida, United States, 33486
Meridien Research
Brooksville, Florida, United States, 34613
Baumel-Eisner Neuromedical Institute, Inc.
Ft. Lauderdale, Florida, United States, 33321
Sunrise Clinical Research
Hollywood, Florida, United States, 33021
Comprehensive NeuroScience
Melbourne, Florida, United States, 32935
Baumel-Eisner Neuromedical Institute
Miami Beach, Florida, United States, 33154
Anchor Research Center
Naples, Florida, United States, 34102
Renstar Medical Research
Ocala, Florida, United States, 34471
Comprehensive NeuroScience
St. Petersburg, Florida, United States, 33702
Meridien Research
St. Petersburg, Florida, United States, 33709
Meridien Research
Tampa, Florida, United States, 33609
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
Research Across America
Dallas, Texas, United States, 75234
Radiant Research
San Antonio, Texas, United States, 78229
Grayline Clinical Drug Trials
Wichita Falls, Texas, United States, 76309
Sponsors and Collaborators
Accera, Inc.
Investigators
Study Director: Sam Henderson, PhD Accera, Inc.
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00142805     History of Changes
Other Study ID Numbers: IA0076
Study First Received: September 1, 2005
Last Updated: December 30, 2008
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by National Institute on Aging (NIA):
ketones
Apolipoprotein E
ApoE genotype
cognitive function
glucose metabolism

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 18, 2014