AC-1204 Long-term Efficacy Response Trial (ALERT Protocol)

Alzheimer's Disease Clinical Trial

— ALERT  

Official title:

A Phase 2-3, 6-12 Month, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Investigate the Effects of Daily Administration of AC-1204 in Subjects With Mild to Moderate Alzheimer's Disease Who Are APOE4(-)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01211782
• Other study ID #: AC-10-006
• Status: Withdrawn
• Phase: Phase 2/Phase 3
• First received: September 24, 2010
• Last updated: December 3, 2012

Study information

• Verified date: December 2012
• Source: Accera, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Description:

Two primary outcome measures will be assessed in APOE4(-) patients:

1. differences from baseline between AC-1204 and placebo groups' ADAS-cog scores at 6 months

2. differences from baseline between AC-1204 and placebo groups' CIBIC+ scores at 6 months Secondary endpoints will include differences between AC-1204 & placebo groups' scores for these same instruments at 3 months.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years to 85 Years

Eligibility

Inclusion Criteria:

• Males/females between age of 55 -85 years

• MMSE scores between 16-26

• Probable mild to moderate AD

Exclusion Criteria:

• Presence of other CNS disorders as alternative causes of dementia

• Type 1 or Type 2 diabetes

• Significant renal/hepatic disease

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• caprylic triglyceride
oral, 20 gm, daily x 6 months
• long-chain triglyceride
oral, 14 gm, daily x 6 months

Locations

Country	Name	City	State
United States	Meridien Research	St. Petersburg	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Accera, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Alzheimer's disease assessment scale - cognitive subscale (ADAS-cog)	change from baseline in ADAS-cog scores at 6 months in APOE4(-) patients	6 months	No
Secondary	Clinicians Interview Based Impression of Change with Caregiver Input (CIBIC+)	change from baseline in CIBIC+ scores at 6 months in APOE4(-) patients	6 months	No