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Alzheimer's DiseasePhase 2/3NOURISH-ADNCT01741194

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

A Phase 2/3 study testing AC-1204 in people with Alzheimer's Disease, run by Cerecin at 82 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 66 to 90 years
Conditions the study is for
Alzheimer's Disease
What is being tested?
AC-1204
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
418 participants
Where
82 sitesUnited States
Study dates
Mar 2013to 14 Apr 2017
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 66 to 90 years
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
Show all 28Show fewer
  • 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
  • Laboratory values for liver function tests > 2.5 times the upper limit of normal at screening or history of severe liver disease
  • Fasting triglycerides > 2.5 times the upper limit of normal at screening
  • Clinically significant B12 deficiency within 12 month prior to screening
  • Inflammatory bowel disease or peptic ulcer disease.
  • Participants with current or a history of (within the last 5 years) complicated reflux disease or severe GERD that is not well-controlled by medication.
  • Irritable bowel syndrome, diverticular disease (e.g., diverticulosis or diverticulitis), or chronic gastritis (exclusionary if there has been a diagnosis or an acute event within 5 years prior to Screening.)
  • Has donated ≥ 2 units of blood within the 2 months prior to screening
  • History of alcohol or drug abuse within 6 months prior to screening, or positive urine drug test at screening
  • Participant or caregiver is an immediate family member or employee of the clinical site, sponsor or sponsor's agents
  • An alternative cause for dementia other than Alzheimer's disease as determined by a required CT or MRI scan within 18 months prior to screening
  • History of neoplasm or malignancies within 5 years prior to screening, except for basal cell or squamous cell carcinoma of the skin
  • Clinically significant hypothyroidism as determined thyroid function testing at screening
  • Participant has scheduled or expected hospitalization and/or surgery during the course of the study

Trial locations and contacts

82 sites in 1 country.

82 sites in 1 country

United States82 sites

  • Albuquerque Neuroscience, Inc.

    Albuquerque, New Mexico, 87109

  • NeuroTrials Research, Inc

    Atlanta, Georgia, 30342

  • Senior Adults Specialty Research, Inc

    Austin, Texas, 78757

  • Pharmasite Research, Inc.

    Baltimore, Maryland, 21208

  • CITrials, Inc.

    Bellflower, California, 90706

  • Comprehensive Clinical Research

    Berlin, New Jersey, 08009

  • Southern Research LLC

    Beverly Hills, California, 90210

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

    Birmingham, Alabama, 35294

  • Parkinson's Disease and Movement Disorders Center of Boca Raton

    Boca Raton, Florida, 33486

  • Alpine Clinical Research Center

    Boulder, Colorado, 80304

  • Integrative Clinical Trials, LLC

    Brooklyn, New York, 11229

  • SPRI Clinical Trials, LLC

    Brooklyn, New York, 11235

  • Meridian Research

    Brooksville, Florida, 34601

  • Neuro-Behavioral Clinical Research, Inc.

    Canton, Ohio, 44718

  • IMMUNOe Research Centers

    Centennial, Colorado, 80112

  • Valley Medical Research

    Centerville, Ohio, 45459

  • Medical University of South Carolina

    Charleston, South Carolina, 29406

  • New Hope Clinical Research

    Charlotte, North Carolina, 28204

  • Ani Neurology, PLLC dba Alzheimer's Memory Ctr

    Charlotte, North Carolina, 28211

  • CTI Clinical Research Center

    Cincinnati, Ohio, 45227

  • Neurology Clinic, P.C.

    Cordova, Tennessee, 38018

  • ATP Clinical Research, Inc.

    Costa Mesa, California, 92626

  • Texas Neurology

    Dallas, Texas, 75214

  • Brain Matters Research

    Delray Beach, Florida, 33445

  • The Mile High Research Center

    Denver, Colorado, 80218

  • Diligent Clinical Trials

    Downey, California, 90241

  • Neuropsychiatric Research Center of Southwest Florida

    Fort Myers, Florida, 33912

  • Clinical Research Solutions

    Franklin, Tennessee, 37064

  • MD Clinical

    Hallandale, Florida, 33009

  • Chase Medical Research of Greater New Haven

    Hamden, Connecticut, 06517

  • Principals Research Group

    Hot Springs, Arkansas, 71901

  • Baylor College of Medicine

    Houston, Texas, 77030

  • IU Health Partners Adult Neurology Clinic

    Indianapolis, Indiana, 46202

  • Borgess Research Institute

    Kalamazoo, Michigan, 49048

  • UCSD Comprehensive Alzheimer's Program

    La Jolla, California, 92037

  • Alliance Research Centers

    Laguna Hills, California, 92653

  • Senior Clinical Trials, Inc.

    Laguna Hills, California, 92653

  • Lake Charles Clinical Trials

    Lake Charles, Louisiana, 70629

  • Alzheimer's Research and Treatment Center

    Lake Worth, Florida, 33449

  • Cleveland Clinic Lou Ruvo Center for Brain Health

    Las Vegas, Nevada, 89106

  • Clinical Trials, Inc.

    Little Rock, Arkansas, 72205

  • Collaborative Neuroscience Network

    Long Beach, California, 90806

  • Alliance for Research

    Long Beach, California, 90807

  • Renew Behavioral Health

    Long Beach, California, 90807

  • The Litwin-Zucker Research Center

    Manhasset, New York, 11030

  • Clinical Neuroscience Solutions, Inc

    Memphis, Tennessee, 38119

  • Miami Jewish Health Systems

    Miami, Florida, 33137

  • NeuroCognitive Institute

    Mount Arlington, New Jersey, 07856

  • Parker Jewish Institute For Health Care & Rehabilitation

    New Hyde Park, New York, 11040

  • NYU Langone Medical Center Comprehensive Center on Brain Aging

    New York, New York, 10016

  • Eastside Comprehensive Medical Center, LLC

    New York, New York, 10021

  • IPS Research Company

    Oklahoma City, Oklahoma, 73103

  • Nathan S. Kline Institute Geriatric Psychiatry Program

    Orangeburg, New York, 10962

  • Compass Research, LLC

    Orlando, Florida, 32806

  • Alzheimer's Research Corporation

    Paterson, New Jersey, 08759

  • Drexel Neurological Associates

    Philadelphia, Pennsylvania, 19107

  • Banner Alzheimer's Institute

    Phoenix, Arizona, 85006

  • HOPE Research Institute

    Phoenix, Arizona, 85018

  • Summit Research Network (Oregon) Inc.

    Portland, Oregon, 97210

  • National Clinical Research - Richmond, Inc.

    Richmond, Virginia, 23294

  • Wasatch Clinical Research

    Salt Lake City, Utah, 84107

  • Pacific Research Network

    San Diego, California, 92103

  • Artemis Institute for Clinical Research

    San Diego, California, 92123

  • Research Across America

    Santa Ana, California, 92705

  • Neurological Research Institute

    Santa Monica, California, 90404

  • Redwood Research Medical Group

    Santa Rosa, California, 95403

  • The Roskamp Institute

    Sarasota, Florida, 34243

  • VA Puget Sound-Alzhemier's Disease Research Center

    Seattle, Washington, 98108

  • Insight Clinical Trials LLC

    Shaker Heights, Ohio, 44122

  • Alzheimers Disease Center, Quincy Medical Center

    Somerville, Massachusetts, 02169

  • Springfield Neurology Associates

    Springfield, Massachusetts, 01104

  • The Cognitive Research Center of New Jersey

    Springfield, New Jersey, 07081

  • Saint Louis University Medical School /Department of Neurology & Psychiatry

    St Louis, Missouri, 63104

  • Meridien Research

    St. Petersburg, Florida, 33709

  • Suncoast Neuroscience Associates

    St. Petersburg, Florida, 33713

  • Axiom Clinical Research of Florida

    Tampa, Florida, 33609

  • Stedman Clinical Trials

    Tampa, Florida, 33613

  • Memory Enhancement Center of NJ

    Toms River, New Jersey, 08755

  • Chase Medical Research, LLC

    Waterbury, Connecticut, 06708

  • Neurology Specialists of Monmouth County

    West Long Branch, New Jersey, 07764

  • Premiere Research Institute

    West Palm Beach, Florida, 33407

  • Abington Neurological Associates

    Willow Grove, Pennsylvania, 19090

Other trials in United States

About this study

Official title: A 26-Week, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Investigate the Effects of Daily Administration of AC-1204 in Participants With Mild to Moderate Alzheimer's Disease (AD) With an Optional 26-Week Open Label Extension

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.

Being tested
AC-1204, Placebo
Medical subject headings
Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AC-1204Drug

    AC-1204 taken once daily, by mouth

  • PlaceboDrug

    Placebo taken once daily, by mouth

Study groups in NCT01741194
Study groupRoleWhat they receive
AC-1204ExperimentalPowder 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.
Receives: Drug: AC-1204
PlaceboPlacebo comparatorPlacebo 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.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    APOE(-) participants

    Measured: 26 weeks

Secondary outcomes (7)

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

    APOE(-) participants

    Measured: 8 and 17 weeks

  2. Clock Draw Interpretation Scale (CDIS)

    APOE(-) participants

    Measured: 8 and 17 weeks

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

    APOE(-) participants

    Measured: 26 weeks

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

    APOE(-) participants

    Measured: 26 weeks

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

    APOE(-) participants

    Measured: 26 weeks

  6. Resource Utilization in Dementia (RUD-Lite)

    APOE(-) participants

    Measured: 26 weeks

  7. Incidence of treatment-emergent adverse events

    All participants

    Measured: 26 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Dec 2012 (estimated)
  2. Study startMar 2013
  3. Primary completion24 Oct 2016
  4. Study completion14 Apr 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
418 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01741194
Sponsor's protocol ID
AC-12-010
Acronym
NOURISH-AD
Status last verified
Jul 2021
First submitted
30 Nov 2012
Last updated
2 Aug 2021
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 32310169

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing AC-1204 in people with Alzheimer's Disease, run by Cerecin at 82 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 82 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) (time frame: 26 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01741194, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2021.

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