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

NCT ID: NCT01211782

Last Updated: 2012-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2/PHASE3

Study Classification

INTERVENTIONAL

Brief Summary

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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

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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.

Conditions

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Alzheimer's Disease

Keywords

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Alzheimer's disease AD AC-1204 ketogenic ketosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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AC-1204

Group Type EXPERIMENTAL

caprylic triglyceride

Intervention Type DRUG

oral, 20 gm, daily x 6 months

Placebo

Group Type PLACEBO_COMPARATOR

long-chain triglyceride

Intervention Type DRUG

oral, 14 gm, daily x 6 months

Interventions

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caprylic triglyceride

oral, 20 gm, daily x 6 months

Intervention Type DRUG

long-chain triglyceride

oral, 14 gm, daily x 6 months

Intervention Type DRUG

Other Intervention Names

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AC-1204 sunflower oil + maltodextrin

Eligibility Criteria

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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
Minimum Eligible Age

55 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cerecin

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mildred Farmer, MD

Role: PRINCIPAL_INVESTIGATOR

Meridien Research

Locations

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Meridien Research

St. Petersburg, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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AC-10-006

Identifier Type: -

Identifier Source: org_study_id