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AC-1204 26-Week Long Term Efficacy Response Trial With Optional Open-label Ext (NOURISH-AD)

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ClinicalTrials.gov Identifier: NCT01741194
Recruitment Status : Completed
First Posted : December 4, 2012
Last Update Posted : May 17, 2017
Sponsor:
Information provided by (Responsible Party):
Cerecin

Tracking Information
First Submitted Date  ICMJE November 30, 2012
First Posted Date  ICMJE December 4, 2012
Last Update Posted Date May 17, 2017
Study Start Date  ICMJE March 2013
Actual Primary Completion Date October 24, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 30, 2012)
Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) [ Time Frame: 26 weeks ]
APOE(-) participants
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01741194 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 8, 2013)
  • Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) [ Time Frame: 8 and 17 weeks ]
    APOE(-) participants
  • Clock Draw Interpretation Scale (CDIS) [ Time Frame: 8 and 17 weeks ]
    APOE(-) participants
  • Alzheimer's Disease Co-operative Study - Clinical Global Impression of Change (ADCS-CGIC) [ Time Frame: 26 weeks ]
    APOE(-) participants
  • Alzheimer's Disease Co-operative Study - Activities of Daily Living (ADCS-ADL) [ Time Frame: 26 weeks ]
    APOE(-) participants
  • Quality of Life - Alzheimer's Disease (QoL-AD) [ Time Frame: 26 weeks ]
    APOE(-) participants
  • Resource Utilization in Dementia (RUD-Lite) [ Time Frame: 26 weeks ]
    APOE(-) participants
  • Incidence of treatment-emergent adverse events [ Time Frame: 26 weeks ]
    All participants
Original Secondary Outcome Measures  ICMJE
 (submitted: November 30, 2012)
  • Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) [ Time Frame: 8 and 17 weeks ]
    APOE(-) participants
  • Clock Draw Interpretation Scale (CDIS) [ Time Frame: 8 and 17 weeks ]
    APOE(-) participants
  • Alzheimer's Disease Co-operative Study - Clinical Global Impression of Change (ADCS-CGIC) [ Time Frame: 26 weeks ]
    APOE(-) participants
  • Alzheimer's Disease Co-operative Study - Activities of Daily Living (ADCS-ADL) [ Time Frame: 26 weeks ]
    APOE(-) participants
  • Quality of Life - Alzheimer's Disease (QoL-AD) [ Time Frame: 26 weeks ]
    APOE(-) participants
  • Resource Utilization in Dementia (RUD-Lite) [ Time Frame: 26 weeks ]
    APOE(-) participants
  • Mini Mental State Exam (MMSE) [ Time Frame: 26 weeks ]
    APOE(-) participants
  • Incidence of treatment-emergent adverse events [ Time Frame: 26 weeks ]
    All participants
Current Other Pre-specified Outcome Measures
 (submitted: May 8, 2013)
  • Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) [ Time Frame: 26 weeks ]
    APOE(+) participants
  • Clock Draw Interpretation Scale (CDIS) [ Time Frame: 26 weeks ]
    APOE(+) participants
  • Alzheimer's Disease Co-operative Study - Clinical Global Impression of Change (ADCS-CGIC) [ Time Frame: 26 weeks ]
    APOE(+) participants
  • Alzheimer's Disease Co-operative Study - Activities of Daily Living (ADCS-ADL) [ Time Frame: 26 weeks ]
    APOE(+) participants
  • Quality of Life - Alzheimer's Disease (QoL- AD) [ Time Frame: 26 weeks ]
    APOE(+) participants
  • Resource Utilization in Dementia (RUD-Lite) [ Time Frame: 26 weeks ]
    APOE(+) participants
  • Mini Mental State Exam (MMSE) [ Time Frame: 26 weeks ]
    APOE(+) participants
  • Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) [ Time Frame: 52 weeks ]
    All participants
  • Alzheimer's Disease Co-operative Study - Clinical Global Impression of Change (ADCS-CGIC) [ Time Frame: 52 weeks ]
    All participants
  • Alzheimer's Disease Co-operative Study - Activities of Daily Living (ADCS-ADL) [ Time Frame: 52 weeks ]
    All participants
  • Quality of Life - Alzheimer's Disease (QoL - AD) [ Time Frame: 52 weeks ]
    All participants
  • Resource Utilization in Dementia (RUD-Lite) [ Time Frame: 52 weeks ]
    All participants
  • Clock Draw Interpretation Scale (CDIS) [ Time Frame: 52 weeks ]
    All participants
  • Ketone body levels (BHB) [ Time Frame: baseline, 8, 17 and 26 weeks ]
    All participants
  • Incidence of treatment-emergent adverse events [ Time Frame: 52 weeks ]
    All participants
  • Mini Mental State Exam (MMSE) [ Time Frame: 52 weeks ]
    All participants
Original Other Pre-specified Outcome Measures
 (submitted: November 30, 2012)
  • Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) [ Time Frame: 8 and 17 weeks ]
    APOE(+) participants
  • Clock Draw Interpretation Scale (CDIS) [ Time Frame: 8 and 17 weeks ]
    APOE(+) participants
  • Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) [ Time Frame: 26 weeks ]
    APOE(+) participants
  • Alzheimer's Disease Co-operative Study - Clinical Global Impression of Change (ADCS-CGIC) [ Time Frame: 26 weeks ]
    APOE(+) participants
  • Alzheimer's Disease Co-operative Study - Activities of Daily Living (ADCS-ADL) [ Time Frame: 26 weeks ]
    APOE(+) participants
  • Quality of Life - Alzheimer's Disease (QoL- AD) [ Time Frame: 26 weeks ]
    APOE(+) participants
  • Resource Utilization in Dementia (RUD-Lite) [ Time Frame: 26 weeks ]
    APOE(+) participants
  • Clock Draw Interpretation Scale (CDIS) [ Time Frame: 26 weeks ]
    APOE(+) participants
  • Mini Mental State Exam (MMSE) [ Time Frame: 26 weeks ]
    APOE(+) participants
  • Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) [ Time Frame: 52 weeks ]
    All participants
  • Alzheimer's Disease Co-operative Study - Clinical Global Impression of Change (ADCS-CGIC) [ Time Frame: 52 weeks ]
    All participants
  • Alzheimer's Disease Co-operative Study - Activities of Daily Living (ADCS-ADL) [ Time Frame: 52 weeks ]
    All participants
  • Quality of Life - Alzheimer's Disease (QoL - AD) [ Time Frame: 52 weeks ]
    All participants
  • Resource Utilization in Dementia (RUD-Lite) [ Time Frame: 52 weeks ]
    All participants
  • Clock Draw Interpretation Scale (CDIS) [ Time Frame: 52 weeks ]
    All participants
  • Ketone body levels (BHB) [ Time Frame: baseline, 8, 17 and 26 weeks ]
    All participants
 
Descriptive Information
Brief Title  ICMJE AC-1204 26-Week Long Term Efficacy Response Trial With Optional Open-label Ext
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE Alzheimer's Disease
Intervention  ICMJE
  • Drug: AC-1204
    AC-1204 taken once daily, by mouth
  • Drug: Placebo
    Placebo taken once daily, by mouth
Study Arms  ICMJE
  • Experimental: AC-1204
    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.
    Intervention: Drug: AC-1204
  • Placebo Comparator: Placebo
    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.
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 5, 2016)
418
Original Estimated Enrollment  ICMJE
 (submitted: November 30, 2012)
480
Actual Study Completion Date  ICMJE April 14, 2017
Actual Primary Completion Date October 24, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 66 Years to 90 Years   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01741194
Other Study ID Numbers  ICMJE AC-12-010
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Cerecin
Study Sponsor  ICMJE Cerecin
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Samuel T Henderson, PhD Cerecin
PRS Account Cerecin
Verification Date May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP