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

Study Overview
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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: 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.

Official Title
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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(-)

Conditions
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Alzheimer's Disease

Intervention / Treatment
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* Drug: caprylic triglyceride
* Drug: long-chain triglyceride


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AC-1204<br> | Drug: caprylic triglyceride<br>* oral, 20 gm, daily x 6 months<br>* Other names: AC-1204;|
| Placebo Comparator: Placebo<br> | Drug: long-chain triglyceride<br>* oral, 14 gm, daily x 6 months<br>* Other names: sunflower oil + maltodextrin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alzheimer's disease, AD, AC-1204, ketogenic, ketosis