Back to results

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

Primary Purpose

Alzheimer's Disease

Status

Withdrawn

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

caprylic triglyceride

long-chain triglyceride

About this trial

This is an interventional treatment trial for Alzheimer's Disease focused on measuring Alzheimer's disease, AD, AC-1204, ketogenic, ketosis

Eligibility Criteria

55 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Meridien Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

AC-1204

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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

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

Secondary Outcome Measures

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

change from baseline in CIBIC+ scores at 6 months in APOE4(-) patients

Full Information

NCT ID

NCT01211782

First Posted

September 24, 2010

Last Updated

December 3, 2012

Sponsor

Cerecin

1. Study Identification

Unique Protocol Identification Number

NCT01211782

Brief Title

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

Acronym

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(-)

Study Type

Interventional

2. Study Status

Record Verification Date

December 2012

Overall Recruitment Status

Withdrawn

Why Stopped

Study never started. Study was redesgined.

Study Start Date

undefined (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Cerecin

4. Oversight

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alzheimer's Disease

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

AC-1204

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

caprylic triglyceride

Other Intervention Name(s)

AC-1204

Intervention Description

oral, 20 gm, daily x 6 months

Intervention Type

Drug

Intervention Name(s)

long-chain triglyceride

Other Intervention Name(s)

sunflower oil + maltodextrin

Intervention Description

oral, 14 gm, daily x 6 months

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

6 months

Secondary Outcome Measure Information:

Title

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

Description

change from baseline in CIBIC+ scores at 6 months in APOE4(-) patients

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

55 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mildred Farmer, MD

Organizational Affiliation

Meridien Research

Official's Role

Principal Investigator

Facility Information:

Facility Name

Meridien Research

City

St. Petersburg

State/Province

Florida

ZIP/Postal Code

33709

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs