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Tricaprilin 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 : September 21, 2020
Sponsor:
Information provided by (Responsible Party):
Cerecin

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.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Drug: Tricaprilin Other: Placebo 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, tricaprilin, 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 tricaprilin 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)
Actual Enrollment : 152 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : November 4, 2004
Actual Primary Completion Date : June 29, 2006
Actual Study Completion Date : January 7, 2007

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: AC-1202
Tricaprilin formulation, once daily. Administered orally
Drug: Tricaprilin
Powder formulation will be mixed in a liquid (approximately 8 oz).
Other Name: AC-1202

Placebo Comparator: Matching Placebo to AC-1202
Placebo formulation, once daily. Administered orally
Other: Placebo
Powder formulation will be mixed in a liquid (approximately 8 oz).
Other Name: Matching placebo to AC-1202




Primary Outcome Measures :
  1. Number of subjects with treatment related adverse events [ Time Frame: 104 days ]
    AE incidence rate per treatment group


Secondary Outcome Measures :
  1. Pharmacokinetics (PK) profile of tricaprilin [ Time Frame: Baseline, Day 45, Day 90 ]
    Correlations between the Cmax serum BHB level on Day 90 and the change from baseline total score for the three efficacy scales was determined by the Pearson correlation statistics

  2. Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) [ Time Frame: 90 days ]
    Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog 11) is an 11- item cognitive subscale that objectively measures memory, language, orientation, and praxis with a total score range of 0 (no impairment) to 70 (severe impairment)

  3. Clinical Global Impression of Change [ Time Frame: 90 days ]
    Clinician's global impression rated with Alzheimer's Disease cooperative Study - Clinical Global Impression of Change (ADCS-CGIC). The rating is from marked improvement to marked worsening.

  4. Mini-Mental State Exam (MMSE) [ Time Frame: 90 days ]
    Change in MMSE



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

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 ClinicalTrials.gov identifier (NCT number): NCT00142805


Locations
Show Show 25 study locations
Sponsors and Collaborators
Cerecin
Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Cerecin
ClinicalTrials.gov Identifier: NCT00142805    
Other Study ID Numbers: KET-04-001
First Posted: September 2, 2005    Key Record Dates
Last Update Posted: September 21, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Cerecin:
ketones
Apolipoprotein E
ApoE genotype
cognitive function
glucose metabolism
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders