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

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(-)

Status

Withdrawn

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01211782

Acronym

ALERT

Enrollment

Registered

2010-09-30

Start date

Unknown

Completion date

Unknown

Last updated

2012-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer's Disease

Keywords

Alzheimer's disease, AD, AC-1204, ketogenic, ketosis

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).

Detailed 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.

Interventions

DRUGcaprylic triglyceride

oral, 20 gm, daily x 6 months

DRUGlong-chain triglyceride

oral, 14 gm, daily x 6 months

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

55 Years to 85 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Alzheimer's disease assessment scale - cognitive subscale (ADAS-cog)	6 months	change from baseline in ADAS-cog scores at 6 months in APOE4(-) patients

Secondary

Measure	Time frame	Description
Clinicians Interview Based Impression of Change with Caregiver Input (CIBIC+)	6 months	change from baseline in CIBIC+ scores at 6 months in APOE4(-) patients

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026