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Ketasyn in Mild to Moderate Alzheimer's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00142805
Recruitment Status : Completed
First Posted : September 2, 2005
Last Update Posted : December 31, 2008
Information provided by:
National Institute on Aging (NIA)

Brief Summary:
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 or disease Intervention/treatment Phase
Alzheimer's Disease Drug: Ketasyn™ (AC-1202) Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
Study Start Date : October 2004
Study Completion Date : March 2006

Resource links provided by the National Library of Medicine

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

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00142805

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Sponsors and Collaborators
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Study Director: Sam Henderson, PhD Cerecin

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00142805    
Other Study ID Numbers: IA0076
First Posted: September 2, 2005    Key Record Dates
Last Update Posted: December 31, 2008
Last Verified: September 2006
Keywords provided by National Institute on Aging (NIA):
Apolipoprotein E
ApoE genotype
cognitive function
glucose metabolism
Additional relevant MeSH terms:
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Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders