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

This study is currently recruiting participants.
Verified February 2014 by Accera, Inc.
Sponsor:
Information provided by (Responsible Party):
Accera, Inc.
ClinicalTrials.gov Identifier:
NCT01741194
First received: November 30, 2012
Last updated: February 18, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Alzheimer's Disease
Drug: AC-1204
Drug: Placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
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

Resource links provided by NLM:


Further study details as provided by Accera, Inc.:

Primary Outcome Measures:
  • Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
    APOE(-) participants


Secondary Outcome Measures:
  • Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) [ Time Frame: 8 and 17 weeks ] [ Designated as safety issue: No ]
    APOE(-) participants

  • Clock Draw Interpretation Scale (CDIS) [ Time Frame: 8 and 17 weeks ] [ Designated as safety issue: No ]
    APOE(-) participants

  • Alzheimer's Disease Co-operative Study - Clinical Global Impression of Change (ADCS-CGIC) [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
    APOE(-) participants

  • Alzheimer's Disease Co-operative Study - Activities of Daily Living (ADCS-ADL) [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
    APOE(-) participants

  • Quality of Life - Alzheimer's Disease (QoL-AD) [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
    APOE(-) participants

  • Resource Utilization in Dementia (RUD-Lite) [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
    APOE(-) participants

  • Incidence of treatment-emergent adverse events [ Time Frame: 26 weeks ] [ Designated as safety issue: Yes ]
    All participants


Other Outcome Measures:
  • Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
    APOE(+) participants

  • Clock Draw Interpretation Scale (CDIS) [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
    APOE(+) participants

  • Alzheimer's Disease Co-operative Study - Clinical Global Impression of Change (ADCS-CGIC) [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
    APOE(+) participants

  • Alzheimer's Disease Co-operative Study - Activities of Daily Living (ADCS-ADL) [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
    APOE(+) participants

  • Quality of Life - Alzheimer's Disease (QoL- AD) [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
    APOE(+) participants

  • Resource Utilization in Dementia (RUD-Lite) [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
    APOE(+) participants

  • Mini Mental State Exam (MMSE) [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
    APOE(+) participants

  • Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    All participants

  • Alzheimer's Disease Co-operative Study - Clinical Global Impression of Change (ADCS-CGIC) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    All participants

  • Alzheimer's Disease Co-operative Study - Activities of Daily Living (ADCS-ADL) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    All participants

  • Quality of Life - Alzheimer's Disease (QoL - AD) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    All participants

  • Resource Utilization in Dementia (RUD-Lite) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    All participants

  • Clock Draw Interpretation Scale (CDIS) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    All participants

  • Ketone body levels (BHB) [ Time Frame: baseline, 8, 17 and 26 weeks ] [ Designated as safety issue: No ]
    All participants

  • Incidence of treatment-emergent adverse events [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
    All participants

  • Mini Mental State Exam (MMSE) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    All participants


Estimated Enrollment: 480
Study Start Date: March 2013
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: AC-1204
AC-1204 taken once daily, by mouth
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.
Drug: Placebo
Placebo taken once daily, by mouth

  Eligibility

Ages Eligible for Study:   66 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01741194

Contacts
Contact: Janet Vogel 303.999-3703 jvogel@accerapharma.com
Contact: Sabrina Greer 303.999.3743 sgreer@accerapharma.com

  Show 65 Study Locations
Sponsors and Collaborators
Accera, Inc.
Investigators
Study Director: Samuel T Henderson, PhD Accera, Inc.
  More Information

Additional Information:
No publications provided

Responsible Party: Accera, Inc.
ClinicalTrials.gov Identifier: NCT01741194     History of Changes
Other Study ID Numbers: AC-12-010
Study First Received: November 30, 2012
Last Updated: February 18, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 16, 2014