AC-1204 26-Week Long Term Efficacy Response Trial With Optional Open-label Ext

NCT01741194 | Completed Phase 2 DMC

• 1 other identifier: AC-12-010
• Study Type: interventional
• Target: 418
• Locations: 1 country
• Sites: 82

Brief Summary

This study will evaluate the effects of daily dosing of AC-1204 on cognition, activities of daily living, resource utilization, quality of life, pharmacokinetic measures and safety among participants with mild to moderate Alzheimer's Disease.

Conditions

Alzheimer's Disease

Outcome Measures

Primary Outcomes (1)

• Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog)

  APOE(-) participants

  26 weeks

Secondary Outcomes (7)

• Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog)

  8 and 17 weeks

• Clock Draw Interpretation Scale (CDIS)

  8 and 17 weeks

• Alzheimer's Disease Co-operative Study - Clinical Global Impression of Change (ADCS-CGIC)

  26 weeks

• Alzheimer's Disease Co-operative Study - Activities of Daily Living (ADCS-ADL)

  26 weeks

• Quality of Life - Alzheimer's Disease (QoL-AD)

  26 weeks

Other Outcomes (16)

• Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog)

  26 weeks

• Clock Draw Interpretation Scale (CDIS)

  26 weeks

• Alzheimer's Disease Co-operative Study - Clinical Global Impression of Change (ADCS-CGIC)

  26 weeks

Study Arms (2)

AC-1204

EXPERIMENTAL

Powder formulation (40 g) mixed with 4-8 ounces of water, other liquid or soft food as preferred, and shaken or blended until fully mixed. Each dosing unit of AC-1204 contains 20 g of the active ingredient, caprylic triglyceride.

Drug: AC-1204

Placebo

PLACEBO COMPARATOR

Placebo is an isocaloric formulation prepared to be virtually identical to AC-1204 in appearance, odor and taste. Powdered formulation is mixed with 4-8 ounces of water, other liquid or soft food as preferred, and shaken or blended until fully mixed.

Drug: Placebo

Interventions

AC-1204 DRUG

AC-1204 taken once daily, by mouth

AC-1204

Placebo DRUG

Placebo taken once daily, by mouth

Placebo

Eligibility Criteria

• Age: 66 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Dementia status of mild to moderate
• CT or MRI scan within 18 months prior to screening compatible with a diagnosis of probable Alzheimer's disease
• Score on the Wechsler Memory Scale - Logical Memory II recall below a pre-determined cut-off, adjusted for education level
• Confirmed apolipoprotein E genotype prior to randomization
• Prior and current use of medication that corresponds with protocol requirements
• Stable medical condition, with the exception of dementia, for at least 3 consecutive months prior to screening
• No active suicidal thoughts within 6 months of screening, no active history of suicide attempt in the previous 2 years, no more than 1 lifetime suicide attempt, no serious suicidal risk
• Able to comply with protocol testing and procedures for the duration of the study
• Has a permanent caregiver (caregiver is not expected to change during the course of the study) who is willing to attend all visits, oversee the participant's compliance with protocol procedures and study medication administration, and report on the participant's status
• Resides in the community (includes assisted living facilities, but excludes long-term care nursing facilities)
• Both participant and caregiver have the ability to read and write in English or Spanish and have hearing, vision and physical abilities adequate to perform the assessments (corrective aids allowed)
• Participant and caregiver have provided full written informed consent prior to the performance of any protocol-specified procedure. If participant is unable to provide informed consent due to cognitive status, provision of informed consent by cognitively intact legally acceptable representative (where this is in accordance with local laws, regulations and ethics committee policy)
• Participant is able to ingest oral medication

You may not qualify if:

• Current use, or use within 3 months of baseline, of medium-chain triglyceride-containing products
• Use of any other investigational agent within 60 days prior to screening
• Known allergy or hypersensitivity to milk or soy products
• In the opinion of the investigator, presence or history of advanced, severe, progressive or unstable disease of any type that could interfere with protocol assessments or put the participant at particular risk
• Any medical or neurological condition other than Alzheimer's disease that could explain the patient's dementia
• History or clinical laboratory evidence of moderate congestive heart failure
• Clinically significant ECG abnormalities at screening
• History of new cardiovascular events within 6 months prior to baseline
• History of or current psychiatric illness
• Major depression as determined by Cornell Scale for Depression in Dementia
• Insulin-dependent diabetics
• Systolic blood pressure \> 165 mmHg or diastolic blood pressure \> 95 mmHg
• Drop of 20 mm Hg systolic blood pressure or greater upon standing upright from a seated position within 3 minutes at screening
• Clinically significant anemia at screening
• Clinically significant renal disease or insufficiency at screening

Sponsors & Collaborators

• Cerecin: lead

Study Sites (82)

University of Alabama at Birmingham, Department of Neurology, Memory Disorders Division

Birmingham, Alabama, 35294, United States

Location

Banner Alzheimer's Institute

Phoenix, Arizona, 85006, United States

Location

HOPE Research Institute

Phoenix, Arizona, 85018, United States

Location

Principals Research Group

Hot Springs, Arkansas, 71901, United States

Location

Clinical Trials, Inc.

Little Rock, Arkansas, 72205, United States

Location

CITrials, Inc.

Bellflower, California, 90706, United States

Location

Southern Research LLC

Beverly Hills, California, 90210, United States

Location

ATP Clinical Research, Inc.

Costa Mesa, California, 92626, United States

Location

Diligent Clinical Trials

Downey, California, 90241, United States

Location

UCSD Comprehensive Alzheimer's Program

La Jolla, California, 92037, United States

Location

Alliance Research Centers

Laguna Hills, California, 92653, United States

Location

Senior Clinical Trials, Inc.

Laguna Hills, California, 92653, United States

Location

Collaborative Neuroscience Network

Long Beach, California, 90806, United States

Location

Alliance for Research

Long Beach, California, 90807, United States

Location

Renew Behavioral Health

Long Beach, California, 90807, United States

Location

Pacific Research Network

San Diego, California, 92103, United States

Location

Artemis Institute for Clinical Research

San Diego, California, 92123, United States

Location

Research Across America

Santa Ana, California, 92705, United States

Location

Neurological Research Institute

Santa Monica, California, 90404, United States

Location

Redwood Research Medical Group

Santa Rosa, California, 95403, United States

Location

Alpine Clinical Research Center

Boulder, Colorado, 80304, United States

Location

IMMUNOe Research Centers

Centennial, Colorado, 80112, United States

Location

The Mile High Research Center

Denver, Colorado, 80218, United States

Location

Chase Medical Research of Greater New Haven

Hamden, Connecticut, 06517, United States

Location

Chase Medical Research, LLC

Waterbury, Connecticut, 06708, United States

Location

Parkinson's Disease and Movement Disorders Center of Boca Raton

Boca Raton, Florida, 33486, United States

Location

Meridian Research

Brooksville, Florida, 34601, United States

Location

Brain Matters Research

Delray Beach, Florida, 33445, United States

Location

Neuropsychiatric Research Center of Southwest Florida

Fort Myers, Florida, 33912, United States

Location

MD Clinical

Hallandale, Florida, 33009, United States

Location

Alzheimer's Research and Treatment Center

Lake Worth, Florida, 33449, United States

Location

Miami Jewish Health Systems

Miami, Florida, 33137, United States

Location

Compass Research, LLC

Orlando, Florida, 32806, United States

Location

The Roskamp Institute

Sarasota, Florida, 34243, United States

Location

Meridien Research

St. Petersburg, Florida, 33709, United States

Location

Suncoast Neuroscience Associates

St. Petersburg, Florida, 33713, United States

Location

Axiom Clinical Research of Florida

Tampa, Florida, 33609, United States

Location

Stedman Clinical Trials

Tampa, Florida, 33613, United States

Location

Premiere Research Institute

West Palm Beach, Florida, 33407, United States

Location

NeuroTrials Research, Inc

Atlanta, Georgia, 30342, United States

Location

IU Health Partners Adult Neurology Clinic

Indianapolis, Indiana, 46202, United States

Location

Lake Charles Clinical Trials

Lake Charles, Louisiana, 70629, United States

Location

Pharmasite Research, Inc.

Baltimore, Maryland, 21208, United States

Location

Alzheimers Disease Center, Quincy Medical Center

Somerville, Massachusetts, 02169, United States

Location

Springfield Neurology Associates

Springfield, Massachusetts, 01104, United States

Location

Borgess Research Institute

Kalamazoo, Michigan, 49048, United States

Location

Saint Louis University Medical School /Department of Neurology & Psychiatry

St Louis, Missouri, 63104, United States

Location

Cleveland Clinic Lou Ruvo Center for Brain Health

Las Vegas, Nevada, 89106, United States

Location

Comprehensive Clinical Research

Berlin, New Jersey, 08009, United States

Location

NeuroCognitive Institute

Mount Arlington, New Jersey, 07856, United States

Location

Alzheimer's Research Corporation

Paterson, New Jersey, 08759, United States

Location

The Cognitive Research Center of New Jersey

Springfield, New Jersey, 07081, United States

Location

Memory Enhancement Center of NJ

Toms River, New Jersey, 08755, United States

Location

Neurology Specialists of Monmouth County

West Long Branch, New Jersey, 07764, United States

Location

Albuquerque Neuroscience, Inc.

Albuquerque, New Mexico, 87109, United States

Location

Integrative Clinical Trials, LLC

Brooklyn, New York, 11229, United States

Location

SPRI Clinical Trials, LLC

Brooklyn, New York, 11235, United States

Location

The Litwin-Zucker Research Center

Manhasset, New York, 11030, United States

Location

Parker Jewish Institute For Health Care & Rehabilitation

New Hyde Park, New York, 11040, United States

Location

NYU Langone Medical Center Comprehensive Center on Brain Aging

New York, New York, 10016, United States

Location

Eastside Comprehensive Medical Center, LLC

New York, New York, 10021, United States

Location

Nathan S. Kline Institute Geriatric Psychiatry Program

Orangeburg, New York, 10962, United States

Location

New Hope Clinical Research

Charlotte, North Carolina, 28204, United States

Location

Ani Neurology, PLLC dba Alzheimer's Memory Ctr

Charlotte, North Carolina, 28211, United States

Location

Neuro-Behavioral Clinical Research, Inc.

Canton, Ohio, 44718, United States

Location

Valley Medical Research

Centerville, Ohio, 45459, United States

Location

CTI Clinical Research Center

Cincinnati, Ohio, 45227, United States

Location

Insight Clinical Trials LLC

Shaker Heights, Ohio, 44122, United States

Location

IPS Research Company

Oklahoma City, Oklahoma, 73103, United States

Location

Summit Research Network (Oregon) Inc.

Portland, Oregon, 97210, United States

Location

Drexel Neurological Associates

Philadelphia, Pennsylvania, 19107, United States

Location

Abington Neurological Associates

Willow Grove, Pennsylvania, 19090, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29406, United States

Location

Neurology Clinic, P.C.

Cordova, Tennessee, 38018, United States

Location

Clinical Research Solutions

Franklin, Tennessee, 37064, United States

Location

Clinical Neuroscience Solutions, Inc

Memphis, Tennessee, 38119, United States

Location

Senior Adults Specialty Research, Inc

Austin, Texas, 78757, United States

Location

Texas Neurology

Dallas, Texas, 75214, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Wasatch Clinical Research

Salt Lake City, Utah, 84107, United States

Location

National Clinical Research - Richmond, Inc.

Richmond, Virginia, 23294, United States

Location

VA Puget Sound-Alzhemier's Disease Research Center

Seattle, Washington, 98108, United States

Location

Related Publications (1)

• Henderson ST, Morimoto BH, Cummings JL, Farlow MR, Walker J. A Placebo-Controlled, Parallel-Group, Randomized Clinical Trial of AC-1204 in Mild-to-Moderate Alzheimer's Disease. J Alzheimers Dis. 2020;75(2):547-557. doi: 10.3233/JAD-191302.

  PMID: 32310169 DERIVED

Related Links

• Alzheimer's Survey

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Samuel T Henderson, PhD

  Cerecin

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2012
• First Posted: December 4, 2012
• Study Start: March 1, 2013
• Primary Completion: October 24, 2016
• Study Completion: April 14, 2017
• Last Updated: August 2, 2021

Record last verified: 2021-07

Locations

US (82)