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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.
 
ClinicalTrials.gov Identifier: NCT00142805
Recruitment Status : Completed
First Posted : September 2, 2005
Last Update Posted : December 31, 2008
Sponsor:
Information provided by:
National Institute on Aging (NIA)

Tracking Information
First Submitted Date  ICMJE September 1, 2005
First Posted Date  ICMJE September 2, 2005
Last Update Posted Date December 31, 2008
Study Start Date  ICMJE October 2004
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: September 1, 2005)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00142805 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 1, 2005)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ketasyn in Mild to Moderate Alzheimer's Disease
Official Title  ICMJE 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
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Alzheimer's Disease
Intervention  ICMJE Drug: Ketasyn™ (AC-1202)
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: September 1, 2005)
100
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE March 2006
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00142805
Other Study ID Numbers  ICMJE IA0076
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Cerecin
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Sam Henderson, PhD Cerecin
PRS Account National Institute on Aging (NIA)
Verification Date September 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP