NCT01211782

Brief Summary

The study will evaluate the safety \& efficacy of AC-1204, a ketogenic compound, administered orally on a daily basis for 6 months. Following the 6 month double-blind phase of the study, subjects may enroll in an optional 6 month open-label extension phase. Efficacy will be evaluated by standard tests of memory and cognition, along with other measurements of activities of daily living and quality of life. Safety will be assessed by frequency of adverse events and changes in laboratory test results. Subjects will be stratified and outcomes will be separately analyzed based on apolipoprotein E4 genotype (APOE4).

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 24, 2010

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 30, 2010

Completed
Last Updated

December 4, 2012

Status Verified

December 1, 2012

First QC Date

September 24, 2010

Last Update Submit

December 3, 2012

Conditions

Alzheimer's Disease

Keywords

Alzheimer's diseaseADAC-1204ketogenicketosis

Outcome Measures

Primary Outcomes (1)

  • Alzheimer's disease assessment scale - cognitive subscale (ADAS-cog)

    change from baseline in ADAS-cog scores at 6 months in APOE4(-) patients

    6 months

Secondary Outcomes (1)

  • Clinicians Interview Based Impression of Change with Caregiver Input (CIBIC+)

    6 months

Study Arms (2)

AC-1204

EXPERIMENTAL
Drug: caprylic triglyceride

Placebo

PLACEBO COMPARATOR
Drug: long-chain triglyceride

Interventions

caprylic triglycerideDRUG

oral, 20 gm, daily x 6 months

Also known as: AC-1204
AC-1204
long-chain triglycerideDRUG

oral, 14 gm, daily x 6 months

Also known as: sunflower oil + maltodextrin
Placebo

Eligibility Criteria

Age55 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males/females between age of 55 -85 years
  • MMSE scores between 16-26
  • Probable mild to moderate AD

You may not qualify if:

  • Presence of other CNS disorders as alternative causes of dementia
  • Type 1 or Type 2 diabetes
  • Significant renal/hepatic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Meridien Research

St. Petersburg, Florida, 33709, United States

Location

MeSH Terms

Conditions

Alzheimer DiseaseKetosis

Interventions

tricaprylinSunflower Oilmaltodextrin

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersAcidosisAcid-Base ImbalanceMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Plant OilsPlant PreparationsBiological ProductsComplex Mixtures

Study Officials

  • Mildred Farmer, MD

    Meridien Research

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 24, 2010

First Posted

September 30, 2010

Last Updated

December 4, 2012

Record last verified: 2012-12

Locations

US(1)