AC-1204 Long-term Efficacy Response Trial (ALERT Protocol) | NCT01211782

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

NCT01211782

Sponsor

Cerecin

Status

Withdrawn

Last Update Posted

Dec 4, 2012Estimated

Enrollment

0Actual

Phase

Phase 2Phase 3

Conditions

Alzheimer's Disease

Interventions

caprylic triglyceride
long-chain triglyceride

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2012

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Study never started. Study was redesgined.

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Sep 24, 2010

First Submission Date that Met QC Criteria

Sep 28, 2010

First Posted Date

Sep 30, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 3, 2012

Last Update Posted Date

Dec 4, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
AC-1204	Experimental		Drug: caprylic triglyceride
Placebo	Placebo Comparator		Drug: long-chain triglyceride

Interventions

Name	Type	Description	Arm Group Labels	Other Names
caprylic triglyceride	Drug	oral, 20 gm, daily x 6 months	AC-1204	AC-1204

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

55 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mildred Farmer, MD	Meridien Research	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Meridien Research		St. Petersburg	Florida	33709	United States

Condition Browse Module

MeSH Terms

ID	Term
D000544	Alzheimer Disease
D007662	Ketosis

Ancestor Terms

ID	Term
D003704	Dementia
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C003637	tricaprylin
D000074242	Sunflower Oil
C008315	maltodextrin

Ancestor Terms

ID	Term
D010938	Plant Oils
D028321	Plant Preparations
D001688	Biological Products
D045424	Complex Mixtures

Browse Leaves

Not provided

Browse Branches

Not provided